Directorate-General for Health and Food Safety
Health programme 2015
Study on the development of a EU common reporting format for
submission of data on ingredients contained in tobacco and related products and disclosure of the
collected data to the public
Final Report
European Regulatory Science on Tobacco Consortium (EUREST)
Consumers Health Agriculture and Food Executive Agency
Edited by C Vardavas amp P Behrakis
EUREST Consortium
112015
Directorate-General for Health and Food Safety
Health programme 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Directorate D mdash Health systems and products
Unit D4 mdash Substances of human origin and Tobacco control
E-mail SANTE-D4-SOHO-and-TOBACCO-CONTROLeceuropaeu
European Commission
B-1049 Brussels
European Commission B-1049 Brussels
Directorate-General for Health and Food Safety
Health programme 2015
Study on the development of a EU common reporting
format for submission of data on ingredients contained in
tobacco and related products
and disclosure of the collected data to the public
European Regulatory Science on Tobacco (EUREST)
Consortium
Led by the Biomedical Research Foundation of the Academy of Athens (BRFAA) in partnership with the European Network on
Smoking and Tobacco Prevention (ENSP)
Directorate-General for Health and Food Safety
Health programme 2015
Europe Direct is a service to help you find answers
to your questions about the European Union
Freephone number ()
00 800 6 7 8 9 10 11
() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
LEGAL NOTICE
This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract
with the Consumers Health Agriculture and Food Executive Agency (Chafea) acting on behalf of the European
Commission
The content of this report represents the views of EUREST and is its sole responsibility it can in no way be
taken to reflect the views of the European Commission andor Chafea or any other body of the European
Union
The European Commission andor Chafea do not guarantee the accuracy of the data included in this report
nor do they accept responsibility for any use made by third parties thereof
More information on the European Union is available on the Internet (httpeuropaeu)
Luxembourg Publications Office of the European Union 2015
ISBN 978-92-9200-680-8
doi10281830286
copy European Union 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme 2015
Contents
1 ABSTRACT 6
2 EXECUTIVE SUMMARY 7
3 RESUME EXECUTIF 13
4 INTRODUCTION AND BACKGROUND 20
5 OVERALL METHODOLOGY 21
6 FINDINGS AND METHODS PER WORK-PACKAGE 22
61 WP1ndash Detailed Methods and Results 22
611 Introduction 22
612 Methodological approach 22
613 Synopsis of EU-MS responses 23
614 Synopsis of Tobacco Industry Stakeholder feedback 25
615 Synopsis of E-Cigarette Industry Stakeholder responses 26
617 Synopsis of the International Experience 27
62 WP2 Detailed Methods and Results 28
621 Introduction 28
623 Data Dictionary and its scientific justification 30
63 WP3 Detailed Methods and Results 33
631 Introduction 33
632 Methodological Approach 33
64 WP4 Detailed Methods and Results 34
641 Introduction 34
642 Methodological Approach 34
643 Synopsis of tobacco industry stakeholder feedback 35
644 Synopsis of e-cigarette industry stakeholder feedback 36
645 Costbenefit analysis 37
7 CONCLUSIONS 42
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
15
Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
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Directorate-General for Health and Food Safety
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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Directorate-General for Health and Food Safety
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Directorate-General for Health and Food Safety
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
EUROPEAN COMMISSION
38
Directorate-General for Health and Food Safety
Health programme
market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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Directorate-General for Health and Food Safety
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
EUROPEAN COMMISSION
40
Directorate-General for Health and Food Safety
Health programme
timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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Directorate-General for Health and Food Safety
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
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Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
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Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
EUROPEAN COMMISSION
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Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
EUROPEAN COMMISSION
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Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
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Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
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Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
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Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
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Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
Directorate-General for Health and Food Safety
Health programme 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Directorate D mdash Health systems and products
Unit D4 mdash Substances of human origin and Tobacco control
E-mail SANTE-D4-SOHO-and-TOBACCO-CONTROLeceuropaeu
European Commission
B-1049 Brussels
European Commission B-1049 Brussels
Directorate-General for Health and Food Safety
Health programme 2015
Study on the development of a EU common reporting
format for submission of data on ingredients contained in
tobacco and related products
and disclosure of the collected data to the public
European Regulatory Science on Tobacco (EUREST)
Consortium
Led by the Biomedical Research Foundation of the Academy of Athens (BRFAA) in partnership with the European Network on
Smoking and Tobacco Prevention (ENSP)
Directorate-General for Health and Food Safety
Health programme 2015
Europe Direct is a service to help you find answers
to your questions about the European Union
Freephone number ()
00 800 6 7 8 9 10 11
() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
LEGAL NOTICE
This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract
with the Consumers Health Agriculture and Food Executive Agency (Chafea) acting on behalf of the European
Commission
The content of this report represents the views of EUREST and is its sole responsibility it can in no way be
taken to reflect the views of the European Commission andor Chafea or any other body of the European
Union
The European Commission andor Chafea do not guarantee the accuracy of the data included in this report
nor do they accept responsibility for any use made by third parties thereof
More information on the European Union is available on the Internet (httpeuropaeu)
Luxembourg Publications Office of the European Union 2015
ISBN 978-92-9200-680-8
doi10281830286
copy European Union 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme 2015
Contents
1 ABSTRACT 6
2 EXECUTIVE SUMMARY 7
3 RESUME EXECUTIF 13
4 INTRODUCTION AND BACKGROUND 20
5 OVERALL METHODOLOGY 21
6 FINDINGS AND METHODS PER WORK-PACKAGE 22
61 WP1ndash Detailed Methods and Results 22
611 Introduction 22
612 Methodological approach 22
613 Synopsis of EU-MS responses 23
614 Synopsis of Tobacco Industry Stakeholder feedback 25
615 Synopsis of E-Cigarette Industry Stakeholder responses 26
617 Synopsis of the International Experience 27
62 WP2 Detailed Methods and Results 28
621 Introduction 28
623 Data Dictionary and its scientific justification 30
63 WP3 Detailed Methods and Results 33
631 Introduction 33
632 Methodological Approach 33
64 WP4 Detailed Methods and Results 34
641 Introduction 34
642 Methodological Approach 34
643 Synopsis of tobacco industry stakeholder feedback 35
644 Synopsis of e-cigarette industry stakeholder feedback 36
645 Costbenefit analysis 37
7 CONCLUSIONS 42
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
EUROPEAN COMMISSION
6
Directorate-General for Health and Food Safety
Health programme
1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
7
Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
8
Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
9
Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
10
Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
15
Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
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Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
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Directorate-General for Health and Food Safety
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
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Directorate-General for Health and Food Safety
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timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
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Directorate-General for Health and Food Safety
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
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Directorate-General for Health and Food Safety
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8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
EUROPEAN COMMISSION
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Health programme
Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
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Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
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Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
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Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
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Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
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Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
EUROPEAN COMMISSION
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Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
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Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
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Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
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Directorate-General for Health and Food Safety
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Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
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Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
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Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
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Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
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Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
Directorate-General for Health and Food Safety
Health programme 2015
Study on the development of a EU common reporting
format for submission of data on ingredients contained in
tobacco and related products
and disclosure of the collected data to the public
European Regulatory Science on Tobacco (EUREST)
Consortium
Led by the Biomedical Research Foundation of the Academy of Athens (BRFAA) in partnership with the European Network on
Smoking and Tobacco Prevention (ENSP)
Directorate-General for Health and Food Safety
Health programme 2015
Europe Direct is a service to help you find answers
to your questions about the European Union
Freephone number ()
00 800 6 7 8 9 10 11
() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
LEGAL NOTICE
This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract
with the Consumers Health Agriculture and Food Executive Agency (Chafea) acting on behalf of the European
Commission
The content of this report represents the views of EUREST and is its sole responsibility it can in no way be
taken to reflect the views of the European Commission andor Chafea or any other body of the European
Union
The European Commission andor Chafea do not guarantee the accuracy of the data included in this report
nor do they accept responsibility for any use made by third parties thereof
More information on the European Union is available on the Internet (httpeuropaeu)
Luxembourg Publications Office of the European Union 2015
ISBN 978-92-9200-680-8
doi10281830286
copy European Union 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme 2015
Contents
1 ABSTRACT 6
2 EXECUTIVE SUMMARY 7
3 RESUME EXECUTIF 13
4 INTRODUCTION AND BACKGROUND 20
5 OVERALL METHODOLOGY 21
6 FINDINGS AND METHODS PER WORK-PACKAGE 22
61 WP1ndash Detailed Methods and Results 22
611 Introduction 22
612 Methodological approach 22
613 Synopsis of EU-MS responses 23
614 Synopsis of Tobacco Industry Stakeholder feedback 25
615 Synopsis of E-Cigarette Industry Stakeholder responses 26
617 Synopsis of the International Experience 27
62 WP2 Detailed Methods and Results 28
621 Introduction 28
623 Data Dictionary and its scientific justification 30
63 WP3 Detailed Methods and Results 33
631 Introduction 33
632 Methodological Approach 33
64 WP4 Detailed Methods and Results 34
641 Introduction 34
642 Methodological Approach 34
643 Synopsis of tobacco industry stakeholder feedback 35
644 Synopsis of e-cigarette industry stakeholder feedback 36
645 Costbenefit analysis 37
7 CONCLUSIONS 42
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
EUROPEAN COMMISSION
6
Directorate-General for Health and Food Safety
Health programme
1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
7
Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
8
Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
9
Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
10
Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
11
Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
13
Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
14
Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
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25
Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
EUROPEAN COMMISSION
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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Directorate-General for Health and Food Safety
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
EUROPEAN COMMISSION
38
Directorate-General for Health and Food Safety
Health programme
market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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39
Directorate-General for Health and Food Safety
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
EUROPEAN COMMISSION
40
Directorate-General for Health and Food Safety
Health programme
timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
EUROPEAN COMMISSION
41
Directorate-General for Health and Food Safety
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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Directorate-General for Health and Food Safety
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
43
Directorate-General for Health and Food Safety
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8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
EUROPEAN COMMISSION
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
EUROPEAN COMMISSION
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
EUROPEAN COMMISSION
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
EUROPEAN COMMISSION
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
EUROPEAN COMMISSION
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Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
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Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
Directorate-General for Health and Food Safety
Health programme 2015
Europe Direct is a service to help you find answers
to your questions about the European Union
Freephone number ()
00 800 6 7 8 9 10 11
() The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
LEGAL NOTICE
This report was produced under the EU Health Programme (2008-2013) in the frame of a service contract
with the Consumers Health Agriculture and Food Executive Agency (Chafea) acting on behalf of the European
Commission
The content of this report represents the views of EUREST and is its sole responsibility it can in no way be
taken to reflect the views of the European Commission andor Chafea or any other body of the European
Union
The European Commission andor Chafea do not guarantee the accuracy of the data included in this report
nor do they accept responsibility for any use made by third parties thereof
More information on the European Union is available on the Internet (httpeuropaeu)
Luxembourg Publications Office of the European Union 2015
ISBN 978-92-9200-680-8
doi10281830286
copy European Union 2015
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme 2015
Contents
1 ABSTRACT 6
2 EXECUTIVE SUMMARY 7
3 RESUME EXECUTIF 13
4 INTRODUCTION AND BACKGROUND 20
5 OVERALL METHODOLOGY 21
6 FINDINGS AND METHODS PER WORK-PACKAGE 22
61 WP1ndash Detailed Methods and Results 22
611 Introduction 22
612 Methodological approach 22
613 Synopsis of EU-MS responses 23
614 Synopsis of Tobacco Industry Stakeholder feedback 25
615 Synopsis of E-Cigarette Industry Stakeholder responses 26
617 Synopsis of the International Experience 27
62 WP2 Detailed Methods and Results 28
621 Introduction 28
623 Data Dictionary and its scientific justification 30
63 WP3 Detailed Methods and Results 33
631 Introduction 33
632 Methodological Approach 33
64 WP4 Detailed Methods and Results 34
641 Introduction 34
642 Methodological Approach 34
643 Synopsis of tobacco industry stakeholder feedback 35
644 Synopsis of e-cigarette industry stakeholder feedback 36
645 Costbenefit analysis 37
7 CONCLUSIONS 42
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
EUROPEAN COMMISSION
6
Directorate-General for Health and Food Safety
Health programme
1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
7
Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
8
Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
15
Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
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Directorate-General for Health and Food Safety
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
24
Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
EUROPEAN COMMISSION
25
Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
EUROPEAN COMMISSION
28
Directorate-General for Health and Food Safety
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
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market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
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timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
43
Directorate-General for Health and Food Safety
Health programme
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
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Health programme
Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
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Health programme
Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
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Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
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Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
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Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
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Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
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Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
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Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
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Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
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Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
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Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
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Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
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Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
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Directorate-General for Health and Food Safety
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Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
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Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
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Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
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Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
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Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
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Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
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Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
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Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme 2015
Contents
1 ABSTRACT 6
2 EXECUTIVE SUMMARY 7
3 RESUME EXECUTIF 13
4 INTRODUCTION AND BACKGROUND 20
5 OVERALL METHODOLOGY 21
6 FINDINGS AND METHODS PER WORK-PACKAGE 22
61 WP1ndash Detailed Methods and Results 22
611 Introduction 22
612 Methodological approach 22
613 Synopsis of EU-MS responses 23
614 Synopsis of Tobacco Industry Stakeholder feedback 25
615 Synopsis of E-Cigarette Industry Stakeholder responses 26
617 Synopsis of the International Experience 27
62 WP2 Detailed Methods and Results 28
621 Introduction 28
623 Data Dictionary and its scientific justification 30
63 WP3 Detailed Methods and Results 33
631 Introduction 33
632 Methodological Approach 33
64 WP4 Detailed Methods and Results 34
641 Introduction 34
642 Methodological Approach 34
643 Synopsis of tobacco industry stakeholder feedback 35
644 Synopsis of e-cigarette industry stakeholder feedback 36
645 Costbenefit analysis 37
7 CONCLUSIONS 42
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
11
Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
13
Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
EUROPEAN COMMISSION
25
Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
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Directorate-General for Health and Food Safety
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
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Directorate-General for Health and Food Safety
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
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Directorate-General for Health and Food Safety
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
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36
Directorate-General for Health and Food Safety
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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37
Directorate-General for Health and Food Safety
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
EUROPEAN COMMISSION
38
Directorate-General for Health and Food Safety
Health programme
market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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39
Directorate-General for Health and Food Safety
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
EUROPEAN COMMISSION
40
Directorate-General for Health and Food Safety
Health programme
timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
EUROPEAN COMMISSION
41
Directorate-General for Health and Food Safety
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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42
Directorate-General for Health and Food Safety
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
43
Directorate-General for Health and Food Safety
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8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
EUROPEAN COMMISSION
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
EUROPEAN COMMISSION
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
EUROPEAN COMMISSION
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
EUROPEAN COMMISSION
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
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Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
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Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
EUROPEAN COMMISSION
6
Directorate-General for Health and Food Safety
Health programme
1 ABSTRACT
The objective of the EUREST (European Regulatory Science on Tobacco) project was to
provide the Commission with a study concerning the development of an common reporting
format for submission of data on ingredients contained in tobacco and related products in
the EU and disclosure of the collected data to the public as laid down the provisions of the
Tobacco Products Directive (TPD) To address this objective four work packages (WPs) were
designed
The first WP aimed at providing an overview of the experience of regulators and stakeholders
with the current and previous reporting formats and mechanisms for which a questionnaire
assessment was performed and supplemented by an evaluation of the status quo of
reporting formats in other non EU areas Within WP2 through the triangulation of a) the
utilisation of the knowledge of the strengths and weaknesses of the current and previous
EU reporting formats b) the evaluation of global best practices and potential public health
impact and c) the provisions of the TPD articles we designed data dictionaries which
propose a structure for the information to be requested As the provisions of the TPD cover
both tobacco products and e-cigarettes with different reporting and notification obligations
two separate data dictionaries were designed Subsequently in WP3 a pilot submission
system platform was developed that outlined the structure and key associations between
variables within each data dictionary Finally in WP4 a qualitative evaluation of the cost
benefit projections for the proposed reporting format was performed
EUROPEAN COMMISSION
7
Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
8
Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
15
Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
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Directorate-General for Health and Food Safety
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
24
Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
EUROPEAN COMMISSION
25
Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
EUROPEAN COMMISSION
28
Directorate-General for Health and Food Safety
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
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market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
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timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
43
Directorate-General for Health and Food Safety
Health programme
8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
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Health programme
Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
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Health programme
Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
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Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
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Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
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Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
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Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
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Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
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Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
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Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
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Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
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Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
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Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
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Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
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Directorate-General for Health and Food Safety
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Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
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Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
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Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
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Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
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Health programme
Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
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Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
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Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
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Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286
EUROPEAN COMMISSION
7
Directorate-General for Health and Food Safety
Health programme
2 EXECUTIVE SUMMARY
One key aspect of the current Tobacco Products Directive (201440EU) (TPD)1 which
the EUREST project specifically addresses is the development of an EU common
reporting format for submission of data on ingredients contained in tobacco and
related products and disclosure of the collected data to the public Indeed the current
TPD stipulates that Member States (MS) require manufacturers and importers of
tobacco products to report on the ingredients used in such products the ground for
their inclusion and relevant toxicological information The TPD seeks to further
harmonise the approach on ingredients regulation in the context of the internal
market and to rationalise the reporting system for manufacturers and importers In
this sense it provides for a common and standardised electronic reporting format for
all Member States for the reporting of tobacco ingredients (Article 5) including both
tobacco leaf and additives (TPD Article 2(18)) The TPD also provides for a common
electronic notification format for electronic cigarettes and refill containers (Article 20)
In order to make the TPD fully operational and to keep up with future trends in the
tobacco sector delegated and implementing powers are foreseen to amend or
supplement the basic act and to give effect or shape the rules laid down in the basic
act Accordingly the Commission shall by means of implementing acts lay down
the common format for the submission and the making available of the required
information on tobacco products (Article 5(5)) as well as the common format for the
notification of the required information on e-cigarettes and refill containers (Article
20(13))
The project was comprised of four work packages which provide an opportunity for
both original data collection as also internal feedback between WPs as outlined below
WP1 Assessed experience with current and previous reporting formats
WP2 Developed the common reporting format
WP3 Developed the pilot submission platform
WP4 Collected feedback and performed basic costbenefit projections
The final and main deliverables of the EUREST project include a) two data dictionaries
that incorporate the domains to be reported within the common reporting format for
tobacco products and common notification format for e-cigarettes respectively and
b) the pilot submission platform that is built on the aforementioned data dictionaries
and facilitates the electronic submission of the data
1 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
Summary of WP1
The objective of WP1 was to perform a critical appraisal and deliver an assessment
of the experience with a) the current reporting format based on the Practical Guide
implemented in 2007 and b) current and previous submission mechanisms used by
manufacturers to submit information to regulators at the EU MS level To address
this objective an active data collection process was initiated during which
questionnaires were sent out to all 28 EU MS a sample of Stakeholders from the
industry as well as non-governmental organisations (NGOs) within the European
Network for Smoking and Tobacco Prevention (ENSP)
The key ldquotake homerdquo points brought forward with regards to the current status quo
on the reporting of information by the industry to regulators were the following
Submission process
Envelopes with combined paperCD submissions were the most common
method of receiving submissions with the majority of information within the
CDs Only a few EU MS were receiving submissions through an online portal
The aforementioned current process was rated as relatively unsatisfactory
with regards to the EU MS ability to check the data access the data perform
data extraction and perform comparisons with the data EU MS indicated that
the implementation of an online submission platform would substantially
improve the capacity of EU MS to address the above functions
The EU MS noted that submissions from the industry are received from
multiple parties including the headquarters if it is an international company
and external parties (ie laboratories legal offices)
The majority of the EU MS noted that the submission mechanism in its
current form does not allow them to perform comparisons of ingredient data
either across time or across companies This was attributed to the difficulties
in merging the different files and categories
Most of the EU MS would be in favour of a common data depository to allow
the sharing of data including a centralised data submission service
Reporting format
Absolute adherence to Table 1-Product Information of the common reporting
format for the submission of tobacco products ingredient information to
regulators2 as provided in the practical guide of 2007 was present in only a
percentage of EU MS
Both EU MS and stakeholders noted a gap in the ability to report unique
products a gap that is still uncovered despite the existence of multiple
product recognition types indicating the need to developdesign a new EU
wide reporting number for unique tobacco products
Both EU MS and stakeholders provided suggestions on how to improve the
component categories of the tables of the common reporting format including
a more detailed breakdown of product categories and new product functions
Ingredients within tobacco products were reported with the use of multiple
parameters including the Chemical Abstract Service (CAS) number common
name or FEMA format (Flavor and Extract Manufacturers Association of the
2 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
9
Directorate-General for Health and Food Safety
Health programme
United States) Industry stakeholders noted their preference towards the use
of the CAS number as the primary ingredient registration number
Industry stakeholders noted that within Table 1 the information provided is
not analytically derived but based more on ldquoupstreamrdquo information provided
to them by suppliers
Table 2-Toxicological data of the common reporting format is currently not
used to full extent by regulators due to a lack of time indicating the
importance of generating predefined ldquoflaggedrdquo parameters during
toxicological reporting
E-cigarettes were addressed separately during the data collection process due to the
fact that no reporting format is currently in place Key points of their feedback
included the following
Stakeholders noted the multiple types of products on the market that would
have to be reported and also the multiple types of hardware combinations
especially for modifiable electronic cigarettes All these parameters would
need to be taken into consideration when reporting a unique product
E-cigarette stakeholders noted that to some extent liquids from providers are
also used while quality control testing is performed by a number of
stakeholders especially for ingredients that may be of greater risk
The large number of existing e-cigarette products and their combinations on
the EU market must be taken into account in the evaluation and reporting of
emissions As there is no standard for measuring these emissions each
company currently uses different testing protocols
Modifications to the existing Table 1- ingredient information would be
necessary so as to facilitate the reporting of e-cigarette ingredients (ie in
ingredient categories function etc)
International best practices from Canada Brazil and the US were also assessed in
WP1 so as to identify what other aspects are routinely reported ndash and of public health
importance - by the industry to regulators outside the EU Such areas included but
were not limited to the way submissions are performed fees and expenses the
flagging of priority additives design parameters and ingredientemission analyses
Summary of WP2
The aim of WP2 was to develop a new
common reportingnotification format for
electronic reporting by manufacturers and
importers of tobacco products This should
allow for the reporting of ingredients and
quantities thereof used in the manufacture
of the tobacco products herbal products for
smoking and electronic cigarettes (including
refill containers) by brand name and type as
well as their emissions and yields to national
regulators so as to monitor and evaluate
products and assess their potential impact
on public health
Within WP2 through the triangulation of a) the utilisation of the knowledge of the
WP1 feedback
TPD Articles
Data Dictionaries
Public Health
relevance
EUROPEAN COMMISSION
10
Directorate-General for Health and Food Safety
Health programme
strengths and weaknesses of the current and previous EU reporting formats as
collected through WP1 b) the potential public health importance of reporting specific
parameters of tobacco products and c) the provisions of the TPD we designed
parameters which outline the information to be requested under the proposed EU
common reportingnotification format
As the articles of the TPD cover both tobacco products and e-cigarettes with different
reportingnotification obligations two separate data dictionaries were designed
for these products These two data dictionaries which are presented in detail within
ANNEX A (tobacco products) and ANNEX B (for e-cigarettes) of this report were
supported by a detailed assessment of the rationale behind the inclusion of each of
the parameters included (ANNEX C)
The data dictionaries are the main outcome of all work performed under the
framework of this specific tender as they present proposed EU common
reportingnotification formats for submission of data on ingredients contained in
tobacco products and e-cigarettes and their refills Ultimately the aim of the two data
dictionaries is to provide background documents that can be consulted to understand
what information is to be requested in the common reportingnotification formats
for both tobacco products and e-cigarettes In general the data dictionaries were
comprised of specific domains which correspond to different categories of
information that is to be reportednotified These domains include
a Submitter Characteristics This functional domain provides regulators with a
clear picture of who is submitting the product information with the use of a
ldquosubmitter-IDrdquo which is a unique ID provided to each submitter of products
so as to chart the association between multiple companies that may market
identical products under different names This Submitter ID is provided within
an offline procedure
b Product Submission and Description Within this domain the notion of a
ldquoProduct-IDrdquo is brought forward which is used as the ldquokeyrdquo to identify unique
products (products with a specific combination of ingredients and design
parameters) and to monitor product changes and the flow of uploading of new
information to the central reporting system This key would also include
information on the submitter the year and the product version Hence by
changing the information within this Product ID one can monitor product
development and the flow of information towards regulators For instance a
modification to a recipe or alteration of a reported design feature would lead
to a change of this product ID for tobacco or e-cigarettes products as the
product itself would not be the same On the other hand a submission of new
informationdata on an existing product (including a change in the external
packaging) NOT leading to a modification in recipe or design would not change
the product ID but update the product version number Within this section
product designingredients were separated from product external
presentation (packaging) to allow for the reporting of products that are
identical (as defined above) in different types of packages without the need
to perform multiple product submissions for each external presentation
c Description of Ingredients (tobacco and additives) These two domains
consist of the variables related to the reporting of tobacco leaf and additives
Details on a number of parameters related to tobacco parts used in tobacco
products are requested here as well as their relative concentrations within the
final product With regards to additives an important aspect within this
EUROPEAN COMMISSION
11
Directorate-General for Health and Food Safety
Health programme
domain is the ability to monitor their potential fluctuation within a specific
production timeframe ndash a key aspect in tobacco product monitoring This
section additionally contains detailed toxicological information for the
regulator in the form of an easy to use checklist
d Emissions This domain covers the reporting of emissions for tobacco
products as also for e-cigarettes As no current emission protocol for e-
cigarettes exists EUREST suggests testing the product for which information
is being submitted with a separate compatible product (hardware or liquid)
e Product specific domains The final section of the data dictionary is modified
according to the product which is being reported Within this section product
specific parameters are requested
Summary of WP3
Subsequently in WP3 a pilot submission system platform was developed outlining
the structure and key associations between variables as outlined in the data
dictionaries produced during WP2 In short WP3 was comprised of 4 consecutive
phases as follows
a) An inception phase During which the translation of the data dictionaries into the
tangible requirements for an electronic platform were produced During this phase
the main entities action types use cases and functional requirements were outlined
and agreed upon The main outcome of this phase was the Use Case document
b) The design phase The design of the pilot electronic platform included the
translation of the requirements as gathered in the analysis to detailed technical
specifications for the final product The main deliverable of this phase was the lsquoData
Modelrsquo The data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the
structure of the presented data
c) Implementation This is the phase that the pilot electronic platform was developed
according to the design which was produced during the previous phase
Implementation was based on Oracle Computer industry specific and technical best
practices and standards to produce a deliverable that is covering all requested
requirements and can be considered as a high end application The final result of the
implementation phase was the User Guide
d) Testing The final stage of the process for creating the EUREST electronic reporting
system was the testing and optimization of the functional product Based on
predefined test cases the pilot product was delivered internally for testing of the
various use cases
The deliverable of WP3 was the verified lsquoApplicationrsquo in its official format
Summary of WP4
The overall aim of WP4 was to provide feedback on the ongoing processes developed
within the previous work packages as also to perform a qualitative cost benefit
assessment of the proposed reportingnotification format and submission
mechanism
Two aspects of research were performed under WP4 The first aspect was to perform
a data collection activity to obtain feedback on draft working versions of the data
EUROPEAN COMMISSION
12
Directorate-General for Health and Food Safety
Health programme
dictionary from a convenience sample of e-cigarette and tobacco industries The
results of these questionnaires were critically appraised by EUREST experts and
constructive comments were incorporated into the data dictionaries of WP2 The
second aspect of WP4 was to perform a basic qualitative assessment of the cost
effectiveness of the proposed solution with feedback also from EU MS Key
conclusions of this process include
The slightly increased administrative burden resulting from the increased
number of parameters that would be requested would nevertheless be
substantially less than if the current status quo of CDpaper submissions
continued with the prerequisite that the submission process across Member
States could be unified to the extent possible
In light of the above central submission system costs that are foreseeable
are those related to the facilitation of an IT system at a national level and
include hardware and software costs as also costs for IT personnel to staff
the system
The administrative burden for national regulators and the Commission from
the adoption of a common reportingnotification format and accompanying IT
submission system is proportionate compared to the obtainable benefits for
the internal market and public health
Industry costs would be of two types one related to the one-off costs of
setting up of the system and one related to the recurring costs both of which
were regarded as limited if the submission process across Member States
could be unified as mentioned above and if solutions for both SMEs (eg
pdfweb submissions) and large system to system XML batch uploading for
larger submitters are provided
Parameters deployed in the data dictionaries would potentially save time and
costs for both the regulators and the industry Such parameters include the
use of a common product IDs across EU MS the ability to transfer information
between products of the same industry
Finally the proposed common reportingnotification format would significantly
increase the information on tobacco producte-cigarette constituents design
parameters and characteristics that would fuel product regulatory science both
at a European level and aid the protection of European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
3 RESUME EXECUTIF
Un des aspects cleacute de la Directive actuelle (201440EU) relative aux produits du tabac
(TPD)3 qui fait lrsquoobjet du projet EUREST est le deacuteveloppement en commun drsquoun modegravele
europeacuteen de transmission de donneacutees sur les ingreacutedients contenus dans le tabac et produits
associeacutes et la publication aupregraves du grand public de ces donneacutees recueillies En effet la TPD
actuelle stipule que les Etats membres (EM) doivent exiger des fabricants et importateurs
de produits du tabac la deacuteclaration des ingreacutedients utiliseacutes dans leurs produits les raisons
pour leur utilisation et les informations relatives agrave leur toxiciteacute La TPD reacuteviseacutee vise agrave
harmoniser encore plus lrsquoapproche de reacuteglementation des ingreacutedients dans le contexte du
marcheacute inteacuterieur et rationaliser le systegraveme de deacuteclaration des fabricants et des importateurs
En ce sens elle preacutevoit un modegravele commun et standardiseacute de deacuteclaration eacutelectronique
destineacute agrave tous les Etats membres pour la deacuteclaration des ingreacutedients du tabac (Article 5) y
compris les feuilles de tabac et les additifs (TPD Article 2(18)) La TPD preacutevoit aussi un
modegravele commun de notification eacutelectronique pour les cigarettes eacutelectroniques et les flacons
de recharge (Article 20)
Afin de permettre agrave la TPD reacuteviseacutee drsquoecirctre complegravetement opeacuterationnelle et agrave jour avec les
nouvelles tendances dans le secteur du tabac il est preacutevu que les pouvoirs deacuteleacutegueacutes et
drsquoexeacutecution changent ou complegravetent lrsquoacte de base et donnent effet ou lsquofaccedilonnent les regraveglesrsquo
inscrites dans lrsquoacte de base Ainsi la Commission doit agrave travers des actes drsquoexeacutecution
eacutetablir un modegravele commun pour la deacuteclaration et mettre agrave disposition les informations
requises lieacutes aux produits du tabac (Article 5(5)) ainsi que le modegravele commun pour la
notification des informations requises des cigarettes eacutelectroniques et flacons de recharge
(Article 20(13))
Le projet est composeacute de quatre tacircches de travail (WP) qui permettent le recueil de donneacutees
ainsi que lrsquoeacutechange interne des informations entre les diffeacuterents WPs tel que le montre le
scheacutema ci-dessous
WP1 Evaluation de lrsquoexpeacuterience avec les modegraveles de notification actuels et passeacutes
WP2 Deacuteveloppement drsquoun modegravele commun de deacuteclaration
WP3 Deacuteveloppement de la plateforme test pour la transmission
3 Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
WP4 Recueil des commentaires et reacutealisation des analyses de lrsquoeacutevaluation de coucirct
par rapport aux avantages
Les eacuteleacutements livrables les plus importants et deacutefinitifs du projet EUREST sont a) deux
dictionnaires de donneacutees comprenant les champs agrave deacuteclareacutes deacutejagrave inclus dans le modegravele
commun de deacuteclaration des produits du tabac et le modegravele commun de notification des
cigarettes eacutelectroniques et b) la plateforme test de transmission construite agrave partir des
dictionnaires de donneacutees preacuteceacutedemment citeacutes et simplifiant la transmission eacutelectronique des
informations
Reacutesumeacute du WP1
Lrsquoobjectif du WP1 est drsquoeacutetablir une analyse critique et fournir une eacutevaluation de lrsquoexpeacuterience
a) du modegravele actuel de deacuteclaration baseacute sur le Guide Pratique mis en application en 2007
et b) des meacutecanismes actuels et passeacutes utiliseacutes par les fabricants pour soumettre les
informations aux instances de reacuteglementation au niveaux des EM europeacuteens Afin drsquoatteindre
cet objectif un processus actif de recueil de donneacutees a eacuteteacute initieacute durant lequel un
questionnaire fut envoyeacute agrave tous les 28 EM europeacuteens un eacutechantillon de les intervenants de
lindustrie ainsi que les organisations non-gouvernementales (ONG) du reacuteseau de lrsquoENSP
(European Network for Smoking and Tobacco Prevention)
Les points cleacutes agrave retenir concernant la situation actuelle de deacuteclaration des informations de
lrsquoindustrie aux instances de reacuteglementation sont
Processus de transmission
Les transmissions par enveloppes comprenant des papiers et CD eacutetaient le plus
souvent utiliseacutees avec la majoriteacute des informations graveacutee sur des CDs Seulement
une poigneacutee drsquoEM recevaient les informations par des portails onlines
Le processus actuel susmentionneacute fut consideacutereacute comme insatisfaisant en ce qui
concerne la possibiliteacute des EM europeacuteens agrave veacuterifier les informations agrave y acceacuteder agrave
extraire les donneacutees et agrave effectuer des comparatifs Les EM europeacuteens ont deacuteclareacute
que la mise en place drsquoun systegraveme de deacuteclaration online pourrait consideacuterablement
ameacuteliorer leur capaciteacute agrave reacutegler les problegravemes preacuteceacutedemment citeacutes
Les EM europeacuteens ont noteacute que les deacuteclarations reccedilues de lrsquoindustrie provenaient de
diverses parties y compris des siegraveges sociaux lorsqursquoil srsquoagissait drsquoentreprises
internationales et aussi des acteurs externes telles que des laboratoires et des
services juridiques
La majoriteacute des EM europeacuteens ont remarqueacute que le processus de notification tel quel
ne leur permettait pas drsquoeffectuer des analyses comparatives de diffeacuterentes donneacutees
des ingreacutedients sur un lapse de temps ou entre les entreprises Ceci est ducirc agrave la
difficulteacute de fusionner les diffeacuterents fichiers et cateacutegories
La plupart des EM europeacuteens seraient favorables agrave une banque de donneacutees
commune ce qui permettrait lrsquoeacutechange de donneacutees y compris un service central de
transmission de donneacutees
Modegravele de deacuteclaration
Adheacutesion absolue au tableau 1 ndash Information sur le produit du modegravele de
transmission drsquoinformation sur les ingreacutedients des produits du tabac aux instances
EUROPEAN COMMISSION
15
Directorate-General for Health and Food Safety
Health programme
de reacuteglementation4 comme preacutevu dans le Guide Pratique de 2007 nrsquoeacutetait respecteacutee
que dans un pourcentage des EM europeacuteens
Les EM europeacuteens ainsi que les parties inteacuteresseacutees ont remarqueacute lrsquoimpossibiliteacute de
deacuteclarer des produits uniques une impossibiliteacute non reacutegleacutee malgreacute lrsquoexistence de
multiples moyens de reconnaissance des produits ce qui indique un besoin de
deacutevelopperconcevoir un nouveau numeacutero uniques de transmission pour les produits
du tabac au niveau europeacuteen
Les ingreacutedients contenus dans les produits du tabac sont deacuteclareacutes agrave travers
lrsquoutilisation de paramegravetres multiples y compris le numeacutero du Chemical Abstract
Service (CAS) nom commun ou bien le numeacutero FEMA (Flavour and Extract
Manufacturers Association des Etats-Unis) Les intervenants de lrsquoindustrie ont
exprimeacute leur preacutefeacuterence pour lrsquoutilisation du numeacutero de CAS en tant que numeacutero
principal drsquoenregistrement des ingreacutedients
Les intervenants de lrsquoindustrie ont expliqueacute que dans le tableau 1 les informations
fournies nrsquoont pas eacuteteacute eacutetablies de maniegravere analytique mais plutocirct baseacutees sur des
informations laquo en amont raquo qui leur a eacuteteacute communiqueacutees par les fournisseurs
Tableau 2 ndash les donneacutees toxicologiques du modegravele commun de deacuteclaration ne sont
actuellement pas utiliseacutees dans leur potentiel maximal par les instances de
reacuteglementation ducirc agrave un manque de temps ce qui indique lrsquoimportance de geacuteneacuterer
des paramegravetres laquo signaleacutes raquo preacutedeacutefinis lors de la deacuteclaration toxicologique
Les cigarettes eacutelectroniques ont eacuteteacute abordeacutees seacutepareacutement pendant le processus de collecte
des donneacutees en raison de lrsquoabsence actuelle drsquoun modegravele de notification Les points cleacutes de
leurs commentaires sont
Les parties inteacuteresseacutees ont remarqueacute les nombreux types de produits sur le marcheacute
qui doivent ecirctre deacuteclareacutes et les nombreux types de srsquoaccessoires notamment pour
les cigarettes eacutelectroniques modifiables Tous ces paramegravetres doivent ecirctre pris en
consideacuteration lors que la deacuteclaration drsquoun produit unique
Les parties inteacuteresseacutees des cigarettes eacutelectroniques ont remarqueacute que jusqursquoagrave un
certain point les liquides des fournisseurs sont aussi utiliseacutes alors que les controcircles
de qualiteacute sont effectueacutes par les parties inteacuteresseacutees et notamment pour les
ingreacutedients qui comporteraient des risques plus eacuteleveacutes
Le nombre eacuteleveacute de produits de cigarettes eacutelectroniques et leur combinaison sur le
marcheacute europeacuteen doit ecirctre pris en compte dans lrsquoanalyse et la communication des
donneacutees drsquoeacutemission Comme il nrsquoy a pas de critegraveres pour mesurer ces eacutemissions
chaque entreprise utilise actuellement des protocoles drsquoanalyse diffeacuterents
Changements dans le tableau 1 existant ndash des informations sur les ingreacutedients
seraient neacutecessaires afin de faciliter le deacuteclaration des ingreacutedients contenus dans les
cigarettes eacutelectroniques (telles que les cateacutegories drsquoingreacutedients leurs fonctions etc)
Des pratiques exemplaires du Canada du Breacutesil et des Etats-Unis ont aussi eacuteteacute eacutevalueacutees
dans le WP1 afin drsquoidentifier drsquoautres eacuteleacutements systeacutematiquement deacuteclareacutes ndash et eacutetant drsquoune
importance pour la santeacute publique ndash par lrsquoindustrie aux instances de reacuteglementation en
dehors de lrsquoUnion Europeacuteenne Ces eacuteleacutements comprenaient entre autres la faccedilon dont les
4 Transmission dinformations sur les ingreacutedients des produits du tabac GUIDE PRATIQUE Bruxelle 31 Mai 2007 Disponible httphealthbelgiumbeinternet2Prdgroupspublicpublicdg4documentsie2divers19071572_frpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
deacuteclarations sont faites les taxes et les frais le signalement des additifs prioritaires les
paramegravetres de design et les analyses des ingreacutedientseacutemissions
Reacutesumeacute du WP2
Le but du WP2 est de deacutevelopper un nouveau modegravele
commun de deacuteclarationnotification pour la deacuteclaration
eacutelectronique des fabricants et des importateurs de
produits du tabac Ceci doit permettre la deacuteclaration
des ingreacutedients et des quantiteacutes utiliseacutes dans la
fabrication des produits du tabac des produits agrave fumer
agrave base de plantes et des cigarettes eacutelectroniques (y
compris les flacons de recharge) par marque et par
type ainsi que leurs eacutemissions et teneurs aux
instances de reacuteglementation nationales afin de
controcircler et drsquoeacutevaluer les produits et analyser leur
impact eacuteventuel sur la santeacute publique
Dans le WP2 agrave travers la triangulation de a) lrsquoutilisation des connaissances des forces et
faiblesses des modegraveles europeacuteens actuels et passeacutes recueillis gracircce au WP1 b) lrsquoimportance
potentielle pour la santeacute publique de deacuteclarer des paramegravetres speacutecifiques des produits du
tabac et c) les dispositions de la TPD nous avons eacutelaboreacute des paramegravetres qui soulignent les
informations requises agrave travers cette proposition de modegravele commun europeacuteen de
deacuteclaration et notification
Puisque les articles de la TPD abordent aussi bien les produits du tabac et les cigarettes
eacutelectroniques avec des obligations de deacuteclarationnotification diffeacuterentes deux
dictionnaires distincts de donneacutees ont eacuteteacute conccedilus pour ces produits Ces deux
dictionnaires de donneacutees preacutesenteacutes de maniegravere deacutetailleacutee en ANNEXE A (produits du tabac)
et ANNEXE B (cigarettes eacutelectroniques) de ce rapport ont eacuteteacute eacutetayeacutes par une eacutevaluation
approfondie des raisons pour la prise en compte de chaque paramegravetre utiliseacute (ANNEXE C)
Les dictionnaires de donneacutees sont les reacutesultats principaux du travail effectueacute dans le cadre
de cet appel drsquooffre puisqursquoils proposent des modegraveles communs europeacuteens de
deacuteclarationnotification pour la transmission de donneacutees sur les ingreacutedients contenus dans
les produits du tabac et les cigarettes eacutelectroniques et leurs recharges
Le but final des deux dictionnaires de donneacutees est de fournir des documents de reacutefeacuterence
qui peuvent ecirctre consulteacutes et permettent de comprendre quelles informations doivent ecirctre
exigeacutees dans les modegraveles commun de deacuteclarationnotification pour les produits du tabac
ainsi que les cigarettes eacutelectroniques De maniegravere geacuteneacuterale les dictionnaires de donneacutees
ont eacuteteacute constitueacutes par des domaines speacutecifiques qui correspondent agrave des cateacutegories
drsquoinformations agrave ecirctre deacuteclareacuteesnotifieacutees Ces domaines comprennent
a) Les caracteacuteristiques de lrsquoauteur de la transmission (le transmetteur) Ce domaine
fonctionnel permet aux instances de reacuteglementation drsquoavoir une ideacutee preacutecise de qui
a effectueacute la transmission des informations du produit agrave lrsquoaide drsquoun laquo submitter-ID raquo
(laquo identifiant-transmetteur raquo) unique agrave chaque personne qui deacuteclarenotifie un
produit afin de visualiser les liens entre les entreprises multiples qui commercialisent
un produit identique avec des noms diffeacuterents Ce Submitter-ID est geacuteneacutereacute agrave travers
une proceacutedure offline
WP1 Commentaires
Articles de la TPD
Dictionnaire des
Donneacutees
Pertinance sur la Santeacute Publique
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
b) La transmission et la description des produits Sous ce domaine la notion drsquoun laquo
Product-ID raquo (laquo Identifiant-Produit raquo) est mise en avant et utiliseacutee comme la laquo cleacute raquo
pour identifier les produits uniques (produits avec une meacutelange speacutecifique
drsquoingreacutedients et de paramegravetres de design) et pour controcircler les changements
effectueacutes sur produits et le flux drsquoinformations teacuteleacutechargeacutees dans le systegraveme central
de transmission Cette cleacute comprendrait aussi des informations sur le transmetteur
lrsquoanneacutee et la version du produit Crsquoest pourquoi en changeant les informations dans
ce Product-ID il est possible de suivre le deacuteveloppement des produits et le flux
drsquoinformations destineacutees aux instances de reacuteglementation Par exemple un
changement dans la recette ou une modification dans les caracteacuteristiques de design
reacutesulterait agrave un changement du Product-ID pour les produits du tabac ou les
cigarettes eacutelectroniques puisque le produit en lui-mecircme ne serait le mecircme Drsquoun
autre cocircteacute une transmission de donneacuteesinformations nouvelles sur un produit deacutejagrave
existant (y compris un changement au niveau du packaging externe) SANS donner
lieu agrave une modification de la recette ou du design ne changerait pas le Product-ID
mais mettrait agrave jour le numeacutero de version du produit Dans cette section le design
et les ingreacutedients du produit ont eacuteteacute seacutepareacutes de la preacutesentation externe du produit
(packaging) afin de permettre agrave la deacuteclaration des produits identiques (comme
deacutefinis preacuteceacutedemment) dans diffeacuterents types de packaging sans avoir besoin de faire
des deacuteclarations de produits multiples pour chaque paquet externe
c) La description des ingreacutedients (tabac et additifs) Ces deux domaines sont composeacutes
de variables associeacutes agrave la deacuteclaration des feuilles de tabac et des additifs Des deacutetails
sur le nombre de paramegravetres associeacutes aux parties du tabac utiliseacutees dans les produits
du tabac sont demandeacutes ici ainsi que leurs concentrations relatives dans le produit
fini En ce qui concerne les additifs un aspect important dans ce domaine est la
possibiliteacute de controcircler leurs fluctuations potentielles pendant un deacutelai de production
speacutecifique ndash un aspect essentiel dans le controcircle des produits du tabac Cette partie
contient eacutegalement des informations toxicologiques deacutetailleacutees pour les instances de
reacuteglementation sous la forme drsquoune checklist facile agrave utiliser
d) Les eacutemissions Ce domaine aborde la deacuteclaration des eacutemissions des produits du
tabac ainsi que des cigarettes eacutelectroniques Comme il nrsquoexiste actuellement pas de
protocole pour les cigarettes eacutelectroniques EUREST propose de tester le produit pour
lequel les informations sont transmises avec un produit compatible distinct
(accessoire ou liquide)
e) Les domaines speacutecifiques au produit La derniegravere partie du dictionnaire des donneacutees
est modifieacutee selon le produit qui est deacuteclareacute Dans ce chapitre des paramegravetres
speacutecifiques des produits sont exigeacutes
Reacutesumeacute du WP3
Dans le WP3 une plateforme test drsquoun systegraveme de transmission a eacuteteacute deacuteveloppeacutee en
preacutecisant la structure et les principales associations entre les variables ainsi souligneacute dans
les dictionnaires agrave donneacutees geacuteneacutereacutes lors du WP2 En un mot le WP3 comprenait les 4 eacutetapes
conseacutecutives suivantes
a) Une phase de deacutemarrage Durant laquelle les dictionnaires de donneacutees ont eacuteteacute traduits
en des besoins concrets pour la plateforme eacutelectronique Au cours de cette eacutetape les
principales caracteacuteristiques les types drsquoactions les cas drsquoutilisation et les exigences
fonctionnelles ont eacuteteacute deacutefinis et convenus La principale reacutealisation de cette phase fut
le document sur les cas drsquoutilisation
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Directorate-General for Health and Food Safety
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b) La phase de conception La conception de la plateforme eacutelectronique test comprenait
la traduction des exigences ainsi recueillies dans l lsquoanalyse en caracteacuteristiques
techniques deacutetailleacutes pour le produit final Le reacutesultat principal de cette phase crsquoest le
laquo Model de Donneacutees raquo Le modegravele de donneacutees classe les variables de chaque
dictionnaire de donneacutees et normalise les eacuteleacutements de donneacutees les uns avec les autres
drsquoougrave le besoin de deacuteterminer la structure des donneacutees preacutesenteacutees
c) La mise en œuvre Crsquoest lrsquoeacutetape ougrave la plateforme eacutelectronique test est deacuteveloppeacutee selon
le design eacutelaboreacute dans lrsquoeacutetape preacuteceacutedente La mise en œuvre fut baseacutee sur les
meilleures pratiques et reacutefeacuterences speacutecifiques et techniques de lrsquoindustrie
informatiqueOracle afin drsquoobtenir un produit qui reacuteponde agrave toutes les exigences et qui
soit consideacutereacute comme un programme de tregraves haut niveau Le dernier reacutesultat de la
phase de mise en œuvre est le Mode drsquoEmploi
d) La phase de test La derniegravere eacutetape dans le processus de creacuteation drsquoun systegraveme de
notification eacutelectronique EUREST est la phase de test et drsquooptimisation du produit
fonctionnel A partir de tests preacutedeacutefinis le produit test fut livreacute en interne pour tester
les diffeacuterents cas drsquoutilisation
Lrsquoeacuteleacutement livrable du WP3 est laquo lrsquoapplication raquo veacuterifieacute dans son format officiel
Reacutesumeacute du WP4
Le but geacuteneacuteral du WP4 eacutetait de fournir des retours sur le processus de deacuteveloppement au
sein des tacircches de travail preacuteceacutedents ainsi qursquoeffectuer une eacutevaluation coucirctbeacuteneacutefices du
modegravele de deacuteclarationnotification et du meacutecanisme de transmission
Deux aspects de recherche ont eacuteteacute effectueacutes par le WP4 Le premier aspect eacutetait de recueillir
des donneacutees afin de drsquoobtenir des commentaires sur les versions provisoires des
dictionnaires de donneacutees drsquoun eacutechantillon de commoditeacute drsquoindustries du tabac et de
cigarettes eacutelectroniques Les reacutesultats de ces questionnaires furent analyseacutes de maniegravere
critique par des experts drsquoEUREST et des commentaires constructifs furent incorporeacutes dans
les dictionnaires de donneacutees du WP2 Le second aspect du WP4 eacutetait drsquoeffectuer une analyse
qualitative de base du rapport coucirctefficaciteacute de la solution proposeacutee avec les commentaires
des EM europeacuteens Les principales conclusions de ce processus sont
La leacutegegravere augmentation des frais administratifs lieacutes agrave lrsquoaugmentation du nombre de
paramegravetres exigeacutes mais consideacuterablement moins que le systegraveme actuel si les
transmissions continuent agrave ecirctre effectueacutees par CDpapier agrave condition que le
processus de transmission entre les eacutetats membres soit unifieacute autant que possible
Compte tenu du systegraveme central de transmission ci-dessus les coucircts preacutevisibles sont
ceux lieacutes agrave la mise en place drsquoun systegraveme informatique au niveau national et
comprennent les coucircts de mateacuteriel et de logiciels ainsi que les coucircts du personnel
informatique employeacute pour le systegraveme
Les frais administratifs pour les instances de reacuteglementation nationales et la
Commission agrave partir de lrsquoadoption du modegravele commun de deacuteclarationnotification
et le systegraveme de transmission informatique qui lrsquoaccompagne sont proportionnels
comparativement aux beacuteneacutefices engendreacutes pour le marcheacute interne et la santeacute
publique
Les coucircts pour lrsquoindustrie seraient de deux sortes le premier eacutetant lieacute agrave des frais
ponctuels pour la mise en place du systegraveme et lrsquoautre lieacute agrave des coucircts reacutecurrents tous
deux peuvent ecirctre minimaliseacutes si le processus de transmission entre les eacutetats
membres est unifieacute comme preacuteceacutedemment mentionneacute et si les solutions sont
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
Health programme
preacutevues aussi bien pour les PME (par exemple PDFtransmission web) que pour les
gros transmetteur (les grands systegravemes et systegraveme XML de teacuteleacutechargement en lot)
Les paramegravetres deacuteployeacutes dans les dictionnaires de donneacutees vont potentiellement
faire gagner du temps et de lrsquoargent aussi bien pour les instances de reacuteglementation
que lrsquoindustrie De tels paramegravetres impliquent lrsquoutilisation de Product-ID communs
dans les eacutetats membres europeacuteens la possibiliteacute de transfeacuterer les informations entre
les produits de la mecircme industrie
Et enfin le modegravele de deacuteclarationnotification commun suggeacutereacute augmenterait
consideacuterablement les informations sur les composants dans les produits du
tabaccigarettes eacutelectroniques concevrait des paramegravetres et caracteacuteristiques qui
alimenterait les sciences regraveglementaires des produits au niveau europeacuteen tout en
aidant agrave la protection de la santeacute publique europeacuteenne
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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4 INTRODUCTION AND BACKGROUND
The objective of this project was to provide the Commission with a study which will
propose a common mandatory format and a pilot submission platform for electronic
reporting of ingredients and emissions by manufacturers to national authorities and
mechanisms for their dissemination to the general public as laid down the provisions
of the TPD The TPD foresees a common electronic reporting format for all Member
States or the reporting of tobacco information from the industry to the regulators
and then to the general public Comprehensive information on ingredients and
emissions to assess addictiveness toxicity and potential characterising flavours of
these products and the risks to health associated with their consumption should allow
Member States and the Commission to exercise their legal obligations to facilitate
the internal market and obtain a high level of public health
The TPD outlines the prerequisite to submit information on ingredients (article 5)
including both tobacco leaf and additives Moreover article 5(6) requires
manufacturers and importers to submit internal and external studies available to
them on market research and preferences of various consumer groups including
young people and current smokers as well as executive summaries of any market
surveys they carry out when launching new products Manufacturers and importers
are also required to report the sales volume data per product In addition article 6
foresees that more detailed information needs to be provided for additives put on a
priority list Similarly to the reporting of tobacco products the TPD also provides the
framework via Article 20(2) for the reporting of parameters related to electronic
cigarettes and their refill containers
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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5 OVERALL METHODOLOGY
Overall Approach
Through a cyclic process there was a specific amount of feedback between individual work
packages of the EUREST tender as outlined in the Figure 2 below Specifically the
information collected from WP1 supported the development of WP2 and WP3 draft
documents and deliverables while the feedback process of WP4 provided information that
enriched the deliverables of WP2 and WP4
While presented in detail within the next chapter in short the methodological approach
used throughout the EUREST tender was as follows
WP1 Experience with current and previous reporting formats
Questionnaire assessment to EU MS regulators and stakeholders
Researcher evaluation of the status quo of reporting formats in other areas
WP2 Development of the common reporting format
Researcher evaluation of information collected in WP1
Researcher evaluation of best practices applied
Researcher review of domains with direct relevance to public health
Internal EUREST group evaluation
WP3 Development of the pilot submission platform
IT development of the structure and prerequisites needed to develop the pilot
submission system platform
IT development of the key associations between aspects to be reported
WP4 Feedback process and basic costbenefit projections
Questionnaire feedback assessment from EU MS regulators and stakeholders
Qualitative evaluation of the costbenefit of each aspect included with a focus on the
impact on European public health
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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6 FINDINGS AND METHODS PER WORK-PACKAGE
61 WP1ndash Detailed Methods and Results
611 Introduction
The rationale behind WP1 was to perform a critical appraisal and deliver an assessment of
the experience with 1) the current reporting format based on the Practical Guide
implemented in 2007 and 2) current and previous submission mechanisms used by
manufacturers to submit information to EU MS regulators This was complimented by a
critical appraisal of the evidence and the assessment of existing formats and international
experience
This aim was addressed through the combination of four questionnaire assessments
One to European Union Member State regulators(EU MS)
One to tobacco industry stakeholders (TIS)
One to e-cigarette industry stakeholders (ECIS)
One to Non-governmental organisations (NGOs)
In addition to the above in depth interviews were performed with selected EU MS
regulators while experts within the EUREST consortium from non-EU countries provided
insight and their experience with established reporting formats implemented in their
jurisdiction
612 Methodological approach
In order to record the experience with the current reporting format and submission
mechanisms regulators in all 28 EU MS were contacted and provided with a questionnaire
This questionnaire covered the EU MS experience with the current reporting mechanism
(Domain 1 of the questionnaire) current reporting format (Domain 2) its current utility
(Domain 3) for which additional information to improve its utility was requested (Domain
4) Finally Domain 5 of the questionnaire covered experience with the reporting format
developed by the Electronic Model Tobacco Control (EMTOC) project for those that had
experience with that electronic submission system
EU MS feedback
Overall regulators from 24 of the 28 MS (86) responded to our data collection request
During the procedure of data synthesis regulators from three MS of the 24 that agreed to
participate were contacted additionally via phone and provided in-depth responses which
provided further details to their written responses
Industry feedback
The rationale behind this activity was to obtain information from TIS and ECIS on mainly
technical information that would aid the development of the new reporting format and
electronic submission platform For this purpose a structured questionnaire was also created
and sent to a convenience sample of TIS and ECIS that operate in EU MS This questionnaire
requested information on current protocols and analyses (Domain 1) methods of
constituent identification (Domain 2) aspects of unique product identification (Domain 3)
trade secrets and market information (Domain 4) and an area for other comments
A total of 11 TIS provided feedback 9 out of 15 initially contacted and two more which
offered to respond to the questionnaire With regards to ECIS 8 were contacted of which 5
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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responded however additional requests during the data collection process were made from
an additional 6 ECIS 4 of which provided feedback In total 10 ECIS returned a completed
questionnaire the responses of which were evaluated
NGO Feedback
For this purpose of obtaining information from non-governmental organization (NGO) which
are active in tobacco control a limited NGO data collection activity was performed among
member organisations of the European Network for Smoking and Tobacco Prevention
(ENSP) Responses were received from 6 NGOs who were invited to provide their feedback
on a number of aspects related to the relationship between access and use of data released
to the general public
613 Synopsis of EU-MS responses
1 Combined PaperCD submissions were the most common method of receiving
information on tobacco product ingredients in 2013 with electronic submissions (via
email or EMTOC) the second most common reporting method While three EU MS
had approximately 50 of submissions in paper only format the majority of EU MS
received gt80 of their submissions via CDs CDs were commonly password
protected
2 With regards to comparing the perceptions of EU MS on their ability to check the
data access the data perform data extraction and perform comparisons with the
data a specific trend across EU MS was noted with the highest scores noted for the
EMTOC submission platformgt by email submissions gt CD submissions gt combined
paperCD submissions gt paper submissions Overall in all cases the EMTOC
submission platform as the only online submission system scored higher than all
other mechanisms in all of the domains noted
3 Among EU MS using the EMTOC submission platform specific domains of utility were
assessed Positive aspects of the EMTOC system included the collection of
comparable data in an electronic format a high level of security mass upload
capacity (XML) and the fact that the system forces the user to complete all fields
Drawbacks of the EMTOC submission platform that were noted include the complexity
of obtaining annually a smart card its administrative and technical needs
maintenance aspects and financial costs its limited use throughout the EU and its
inability to produce predefined reports These issues would need to be addressed in
an updated submission platform
4 With regards to product submissions to EU MS the majority of MS stated that tables
of ingredient data and supporting files that the industry submits are completed by
the international headquarters of each industry However tables and supporting files
are also directly sent to them by external parties (ie laboratories) on behalf of the
industry Legal offices were also mentioned This broad spectrum of users verifies
the need to be able to document and record the details of these submitting parties
via a central submission office
5 Absolute adherence to Table 1-Product Information of the common reporting format
for the submission of tobacco products ingredient information to regulators5 as
5 Reporting on tobacco product ingredients PRACTICAL GUIDE Brussels 31 May 2007 Available athttpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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provided in the practical guide of 2007 was present in 1024 of EU MS that
responded with the majority noting that while most companies comply with Table 1
data submissions for their products some gaps exist Blank responses within specific
columns andor submissions in non-tabular format were identified as potential issues
to be addressed in a potential updating of the reporting format or submission
platform With regards to the submission language of Table 1 data the majority of
submissions were in English with some albeit limited evidence of intra-EU language
submissions
6 With regards to component categories of Table 1 discrepancies in the reporting of
Ingredient Categories (Table 1- Column 12) was noted while Ingredient Quantity
values (Table 1- Column 14) were often non consistently reported across companies
while the numbers provided were not always accompanied by any methodology of
how they are were defined With regards to Ingredient Functions (Table 1 - Column
15) potentially additional functions were proposed for inclusion
7 The most commonly used format of ingredient submissions in Table 1 either included
a Chemical Abstract Service (CAS) registration number or was only of CAS
registration format The most common reporting format after CAS was of FEMA
format (Flavor and Extract Manufacturers Association of the United States)
8 With regards to the utility of Table 1 data 1218 of EU MS reported that they were
able to use the ingredient data from the industry On the contrary the majority had
never compared ingredient data either between products or between years Notably
issues of time and resources were brought up as the rationale behind this gap an
issue which may be addressed when developing a new reporting format and
submission mechanism The aspect of lack of time or expertise corroborates the need
to develop an electronic reporting platform that would be user friendly and provide
automated reports for easy data extraction and immediate use in regulatory
processes
9 With regards to Table 2-Toxicological information data of the common reporting
format for the submission of tobacco products ingredient information to regulators
the vast majority of submitted files were in English language with a number of EU
MS reporting that they never received any supporting information Moreover it was
noted that the information submitted is too technical or not easily accessible
readable and user friendly A consensus was that most EU MS do not seem to be
requesting this data or regard it as too complicated for use in daily regulatory
activities
10 Notably 1317 of EU MS were not able to use the supporting toxicological data
submitted to them (Table 2) The lack of time resources or capacities to utilize this
data was noted Specific counter options were suggested for the easier submission
and use of data Based on the feedback from EU MS the current running hypothesis
is that this data should also be coded into specific easier to use formats (ie
checkboxes for CMR properties)
11 With regards to publicly available Table 3 data 1520 EU MS reported that the data
for Table 3 is available on the web for the general public however only 720 MS
reported that the results that are uploaded are in a process able or searchable
format with 820 reporting that data is uploaded in a static format such as a pdf or
picture file This warrants the need to develop user access for the public where they
should be able to log-on and obtain downloadable versions of the publicly available
information in a searchable format
12 Overall EUREST asked EU MS to provide their feedback on how they would wish to
receive Table 1 data with all EU MS responding that it should be via electronic only
submissions with a number of MS requesting a centralized data submission system
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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and joint EU database EU MS requested changes in the way Table 2 data is reported
to them and which aspects it should cover while solutions for the collection of sales
and market data were also noted These suggestions were taken into account during
the formulation of the proposed new common reporting format and electronic
submission platform
13 Finally EU MS were almost all in favour of sharing data across the EU with the
exception of two MS (one of which reported organizational constraints) indicating a
significant alignment to the common goal of the TPD across the EU MS
614 Synopsis of Tobacco Industry Stakeholder feedback
1 Overall 11 TIS provided feedback 10 companies and one association
2 Specific product types were proposed based on the new requirements of the TPD
including the addition of Cigarillos Chewing tobacco Nasal tobacco Oral tobacco
Electronic cigarettes Novel tobacco products Herbal products for smoking
3 New ingredient functions were proposed for a number of ingredient categories while
others were requested to be removed based on changes to the TPD Corrections were
proposed especially for cigars and cigarillos
4 With regard to reporting of ingredient quantities the TIS reported that these
quantities are not analytically derived and are mainly based on the suppliers
disclosures multiplied with the application rate in production
5 Batch modification due to deliberate changes were reported to be performed on a
number of products per year with the percentage of modifications that exceeded a
5 change in ingredient quantity were identified to be fewer Batch-related
maintenance activities were reported by a number of TIS
6 Importantly the best practice for the reporting of ingredients as noted by the TIS
was the use of the CAS number as the primary ingredient registration number As
certain discrepancies were noted in the reporting of CAS numbers or due to their
inexistence for certain semi-refined natural commodities the CAS number was
recommended to be complemented by an ingredient name and a secondary
ingredient registration number The issue of how to handle multiple CAS numbers
was also noted as was the potential role of the existing EMTOC-Ingredient ID
7 With regards to identification formats that would aid unique product identification
multiple formats were mentioned none however were of universal form Most
formats were either for internal use only or did not allow for comparisons between
products or years The UPC EAN GTIN SKU numbers were approaches outlined to
be of interest
8 Tobacco leaf parameters were all regarded as trade secrets similarly sales and
market data studies were also regarded as trade secrets and should be available only
to regulators
9 As to the TIS experience with the current submission mechanism most TIS had
experience in multiple mechanisms including CD CDpaper and EMTOC Smaller
industries were more experiences in paper only submissions
10 The EMTOC reporting mechanism was assessed separately Overall EMTOC scored
highly on almost all domains with a number of exceptions in a few cases The scoring
was very similar to the scoring of MS in range (with the exception that the TIS
requested domains were more technically oriented while MS domains were utility
oriented)
11 EMTOC was regarded overall as user friendly and inexpensive While accessing
overall EMTOC was noted as easy the registration process was noted as potentially
an area that may be improved This aspect was brought forward also by the EU MS
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Directorate-General for Health and Food Safety
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With regards to data protection while the transmission of data was generally
regarded as secure the TIS mentioned concerns with regards to potential mistakes
in uploading public files and the fact that a number of legal files have not been
finalized or accepted by relevant parties
12 With regards to EMTOCrsquos technical infrastructure the ability to perform XML uploads
was perceived very positively however the maximum upload able file size was noted
as an area in need of updating
615 Synopsis of E-Cigarette Industry Stakeholder responses
1 The list of ECIS while a convenience list and in not a comprehensive list of
manufacturers did indicate the broad types and design features of the products
marketed in the EU Notably the ECIS also brought forward that existence of a
plethora of combinations of products when one takes into account the number of e-
cigarettes (hardware) and the number of compatible e-cigarette liquids and the
different combinations of each of the above Especially for modifiable (MOD) e-
cigarettes the reporting of the ability to alter airflow the voltage the battery the
programming and the flavors were all aspects noted as essential to aid unique
product identification
2 Almost all ECIS reported that they perform chemical and toxicological assessment of
their products while EUREST toxicologists noted that appropriate chemical evaluation
methods were reported by the industry
3 Some manufacturers do not manufacture the liquid themselves but purchase it from
external suppliers (which EUREST notes is similar to the process that conventional
cigarette manufacturers purchase leaf of composite materials from external suppliers
too)
4 Overall chemical assessment is performed on a range of substances with a focus on
those that as indicated by the literature may be produced by the thermal degradation
and on those substances that may be of significant concern to users
5 The ECIS noted that testing may also be performed to evaluate product stability and
leaching due to the storage processes an aspect which should also be evaluated and
potentially reported as part of ldquoquality controlrdquo in all phases of production
6 ECIS perform routine production and quality control on their products on a broad
range of aspects and this should not be difficult to be reported to regulators Specific
production control guidelines do exist in the industry and are noted by ECIS to be
implemented
7 It is possible that the number of chemical analyses especially for MOD products
may be especially complex and this may affect the reporting of the emissions of
these products
8 Multiple emission protocols are used by ECIS which would make the reporting of
emissions very complex for e-cigarettes This has the unfortunate result that
emission data between companies under the current status quo is not comparable
The development of such standardized protocols test and procedures is needed so
as to be able to perform any homogenous reporting
9 ECIS noted that valuating nicotine dosing in the liquid is easy to perform while
nicotine dosing in emissions would be a complex process Nicotine pharmacokinetic
studies have been performed only by a small number of ECIS and on a limited scale
10 Specific terms were proposed by ECIS for the updating of the existing reporting
format so that it may also allow for the reporting of e-cigarettes These terms have
been included in the data dictionary and are based on the existing ingredient
categories with a number of new additions
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11 ECIS noted that there are substantial differences in design characteristics of e-
cigarettes which may be reported Such aspects include the Battery type voltage
wattage delivery and recharge requirements Product Size and weight Battery
charge capacity Thread fitting Variable or fixed voltage etc These variables would
also allow for unique product identification especially for MODs These indexes
reflect also the plethora of products available in the EU market
12 With regards to the reporting of market and sales data while this data is collected
by some ECIS EUREST was not provided with an example so as to be able to assess
if the market research data collected can be reported to regulators in a format other
than a single pdf file This approach was incorporated into the proposed reporting
format With regards to sales data the majority of ECIS noted that the best way for
it to be reported would be the ldquototal number of units for different product typesrdquo
13 As with the TIS ECIS were strongly in favour of the use of the CAS number for the
reporting of ingredients to regulators This was substantially different from the
response to the potential use of the European Community Number the IUPAC
number or the FL number which may be necessary though for the reporting of
ingredients that are extracts of natural sources
14 With regards to product identification as with the TIS the ECIS indicated no
universal identification code that could be used for product recognition even though
most ECIS noted that they use an identification system with the UPC code noted as
the most commonly used in tandem with an internal production code
15 Other aspects that were brought forward include the rationale for the inclusion of
safety parameters related to the use and disposal of electrical circuitry
616 Synopsis of Non-Governmental organization Feedback
1 Overall 5 out of 6 NGO respondents were aware of the reporting of ingredients to
the national regulators but have not seen any publicly available data
2 Only one NGO reported that they had access to the publicly available data None
reported that they were able to use it though
3 Of more interest was the perceived value of being able to download the publicly
available raw constituent list of all tobacco products which was perceived as relatively
useful however the importance of including e-cigarettes was stressed
4 Moreover the feedback from the NGOs indicated that information on additives and
flavors should be included in reports to the public while if they were to choose
between obtaining raw data of the publicly available information or reports on
predefined aspects in most cases raw data was noted as the preferred method of
receipt
617 Synopsis of the International Experience
Within WP1 an active data collection process with EUREST international experts from Canada
and the US was performed and assessed domains that were perceived either to be of direct
interest to the reporting format or to the submission mechanism Information on the
current reporting process in Brazil was also evaluated as available in the general domain
Overall each international reporting format and process has its own strengths that were
assessed for potential inclusion in the proposed new EU common reporting format within
the context of the TPD
An overview of the reporting formats implemented in other countries across the globe
indicates that the proposed EU reporting format will be a substantial departure from the
status quo especially for e-cigarettes and refill liquids at the time this was assessed as
outlined in the reporting prerequisites of the three aforementioned countries
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Directorate-General for Health and Food Safety
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We synthesize the international experience as follows
Data submission in all countries is performed electronically either via CD or through
an online submission system
Fees are organized in the US and Brazil to cover running expenses This is not done
in Canada The US approach provides a detailed methodology for the attribution of
fees
Detailed information on the laboratories manufacturers and importers should be
collected an issue that is not extensively collected in the current EU reporting
format
International experience notes that detailed and extensive toxicity testing may have
limited applied use effort should be made to make this information as easy to use ndash
and understand- as possible Regulators seem to find this information of limited use
in its current ldquofile onlyrdquo format This verifies EURESTs working hypothesis to note the
necessity to adopt ldquocheckboxesrdquo and selected checklists that would complement pdf
file collection
In line with the above other reporting formats highlight separately those
constituents which they deem as important to public health an approach that may
be applicable in an EU reporting format ie flagging a priority toxicant list or priority
additive list
Identifying unique products was an issue noted by all other reporting formats
Multiple methods are used with all evaluated noted to incorporate the dual use of a
ldquotextrdquo area and the provision of a product identifier (ie the SKU or the UPC number)
No specific system was deemed as ideal
Chemical substances seem to be reported inconsistently however the three
aforementioned international reporting formats do note the use of CAS numbers as
a prerequisite often accompanied by again a ldquotextrdquo box This aspect may be
applicable to the EU reporting mechanism and was strongly supported by MS and
Industry responses EUREST experts verified the importance of the CAS as the ldquobest
practicerdquo in chemical reporting
Information on filter specifications and other design elements is often collected that
can be related to smoking intensity
Ingredient analyses can contain mean and standard deviation of result analyses
Canada includes also the 95 CI for emission analyses not on ingredient
quantities
Information on tobacco ingredient part can include the leaf type the cure method
and the existence of expanded andor reconstituted tobacco
An example of the package is often collected even if only in electronic format
E-cigarettes are not included in any other reporting format Hence this will be a
completely novel area that the TPD will need to address
62 WP2 Detailed Methods and Results
621 Introduction
The aim of WP2 was to develop a new common reporting format for electronic reporting by
manufacturers and importers of tobacco products This should allow for the reporting of
ingredients and quantities thereof used in the manufacture of the tobacco products herbal
products for smoking and electronic cigarettes (including refill containers) by brand name
and type as well as their emissions and yields to national regulators so as to monitor and
evaluate products and assess their potential impact on public health
622 Methodological approach
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WP2 was based on the combination of evidence available from three sources that included
1 The synthesis of the data collected in WP1 through the questionnaires and interviews
with regards to the reporting requirements and processes of the European Directive
2001376and the practical guide on reporting on tobacco product ingredients published
on 31 May 20077
2 A selected evaluation of the scientific evidence for each of the aspects brought forward
and discussed In addition relevant legal technical and background documents with
regard to ingredient reporting and disclosure from within the EU and at international
level were considered This search strategy was complemented by a snowball data
collection through the evaluation of the references of those documents and the provision
of additional files from EUREST counterparts that would provide the scientific justification
to the regulatory options brought clearly forward in the wording of the TPD Other
relevant legal technical and background documents with regard to ingredient reporting
and disclosure from within the EU and at international level were also considered
3 The wording and contextual interpretation of the Articles of the TPD8
As significant differences exist between e-cigarettesrefill liquids and tobacco products
regulated under the auspices of the TPD and as the inclusion of e-cigarettes and their refill
liquids is a novel aspect of the TPD special emphasis was placed on the development of a
notification format for these products Hence the EUREST consortium opted to approach
separately the issue of a notification format for these products and thus the final deliverables
of WP2 were two separate ldquoData Dictionariesrdquo which include the variables ndashand their
description where possible- that EUREST proposes should be included in the common
notification format The aim of these two data dictionaries is to provide a background
document that can be consulted to understand what information is to be requested in the
common reporting format for both tobacco products and e-cigarettes These data
dictionaries hence become central documents of WP2 as it outlines and describes what
information the common reporting format would request the values that each response
would take what the data item practically means in real-world terms and where a data item
fits in the structure of a submission mechanism (ie a flowchart process within which some
variables may be requested based on the response to previous questions an area developed
in WP3)
The Data dictionary for tobacco products and the data dictionary for e-cigarettes including
their refill mechanisms are provided as Annexes to this report (ANNEX A and ANNEX B
respectively) Within these data dictionaries after each item is numbered (column 1) it is
given a descriptive name ldquofieldrdquo (column 2) a brief textual description is provided
ldquodescriptionrdquo (column 3) the data type is identified (column 4) white list terms are noted
(column 5) possible predefined values are listed (column 6) mandatory and non-
6Directive 200137EC of the European Parliament and of the Council on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco products OJ L 194 1872001 7httpeceuropaeuhealthph_determinantslife_styleTobaccoDocumentspractical_guidance_enpdf 8Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws regulations and administrative provisions of the Member States concerning the manufacture presentation and sale of tobacco and related products and repealing Directive 200137EC Available from httpeur-lexeuropaeulegal-contentENTXTuri=OJL2014127TOC
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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mandatory items for reporting are identified (column 7) and their confidential vs public
visibility (column 8)
623 Data Dictionary and its scientific justification
The data dictionaries are the epitome of all work performed under the framework of this
specific tender as it presents the new proposed EU common reporting format for submission
of data on ingredients contained in tobacco products and e-cigarettes and their refills and
related products and disclosure of the collected data to the regulators and public In addition
the TPD also requires special reporting for herbal products for smoking and novel tobacco
products While not covered by the common format we must state that it could be practical
for specific variables within the common reporting format to be used
A more technical and scientific justification of the terms to be included within the data
dictionary is provided in Annex C however below we provide an overview of the main
domains included within the data dictionaries and their rationale
The data dictionaries are comprised of a number of common domains and also domains that
are specific to each type of product regulated under the TPD The key domains include
a) Submitter characteristics (Section 22)
Within this introductory and ldquofunctionalrdquo domain the aim was to collect the necessary
information that would provide the regulators with a clear picture of the associations
between the manufacturerimporter and potential affiliate subsidiary and primary
companies so as to be able to chart the association between multiple companies that may
market identical products under different names This domain sets the scene and describes
these associations so that the products reported below can be assessed appropriately The
key to this domain is the ldquoSubmitter IDrdquo an identification number that would be unique for
each submitter and would be provided centrally by the administrator
B1) Product Submission and Description (Section 23A)
This section of the data dictionary contains information on three key variables of the data
dictionary on which all subsequent variable are dependant i) the type of actual product for
which the submission is taking place ii) the type of submission and iii) its tobacco product
ID (TP-ID) or e-cigarette ID respectively (EC-ID) These IDs contain inherent information
such as the submitter ID the year the product was first marketed and the product version
number (attributed by the submitter the first time the product is submitted This centrally
provided ID will allow regulators to identify identical products in multiple markets and allow
for the creation of a complete list of all tobacco products within the EU market an important
aspect of tobacco product monitoring
An important aspect is the monitoring of changes that take place after a product is placed
on the market This is monitored through the introduction of a variable that monitors the
submission type which would allow based on the perform activity to either request a new
TP-ID or update the version of the TP-ID An important point that EUREST stresses is that
in principle any substantial modification to a recipe or alteration of a reported design feature
would lead to a change within the Product ID On the other hand a submission of new
informationdata on an existing product NOT leading to a substantial modification in recipe
or design would not change the product ID but update the product version number (so as
to reflect the current status and to allow for product monitoring)
B2) Product Submission and Description (Section 23B) ndash product presentation
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The need to develop a new method for identifying and coding unique tobacco
productselectronic cigarettes in an orderly fashion was outlined by the activities of WP1
which indicated that the current status quo was to report the product by its brand name ndash
information which was neither homogenously coded nor written Keeping in mind that there
will be a unique product ID (TP-ID or EC-ID) within the previous section of the Data
Dictionary within this section (23B) information on product name and product brand
subtype name are maintained from the current reporting format It was noted that in some
cases products with the same product ndash of identical ingredient ldquoreciperdquo and design (ie
dimensions weight filter etc)- are marketed in different product presentations (ie external
packaging) which would lead to a significant increase in reporting burden if reported
individually (per presentationpackaging) Moreover regulators would benefit from a deeper
understanding and reporting of the relationship between a product and its presentation while
from a public health perspective the ingredient quantities and product design parameters
are related to constituent uptake in comparison to outside product presentation With the
above in mind EUREST introduced the notion of allowing one unique product (unique recipe
and design) to be reported under the same product ID (TP-ID and EC-ID) for multiple
product presentations
Per presentation a list of parameters is to be reported with regards to potential product
launch date package types sale volume market data a picture of the outside packaging
of the product etc
c) Description of Ingredients Tobacco (Section 23B)
A significant departure from the current status quo is the inclusion of information on tobacco
leaf and other tobacco part types Tobacco is a central ingredient in tobacco products and
the reporting of tobacco types would provide the regulators and the public significant
information with regards to the main ingredient in these products Information would include
the tobacco part type a description of what it entails its source leaf type cure method and
quantity While regulators would obtain an in-depth analysis of the constituents EUREST
notes that it is imperative that the public also receive information on the tobacco parts
included within tobacco products above a certain threshold as handled for additives While
it was not possible to conclude within the framework of this tender on what would be the
optimal cut-off for such a confidential vs public reporting we believe that it should be at the
05 level as for additives
Indeed the approach proposed by EUREST is that the reporting of tobacco parts would follow
the same motive as other ingredients (ie additives) and would be reported (by quantity
per above characteristic ie part typegtleaf typegtcure method) For instance a specific part
type with the same leaf type but with two cure methods would be reported separately
d) Description of ingredients Additives and other substanceselements (Section 25)
This section is an expansion of Table 1 and Table 2 of the current reporting format outlined
in the Practical for the Reporting of Tobacco products in 2007 for which each ingredient
added is reported separately for each of the product components or materials to which it is
included It was noted however in the current format that no specific identifier of chemical
substances was used while often different language names were also used for the same
chemical substance To avoid this issue EUREST proposed to base the reporting on a CAS
number as the key unique identifier of chemical substances followed by other reporting
numbers if available to the submitter
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Directorate-General for Health and Food Safety
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An important issue that EUREST raises in WP2 and in this section of the data dictionary is
the issue of ingredient fluctuation ie that the ingredient quantity in a tobacco product may
fluctuate as a result of alteration of the recipe to adjust for natural variations in tobacco
leaf This led to the development of two parallel parameters product recipe and product
measured quantity within a standardised timeframebatch This is based on the hypothesis
that a manufacturer will make a product based on certain recipe specifications which are
known before the product is created Subsequently should the manufacturer adjust the
added concentrations of additives to adjust for potential variations then the measured
values should also be provided to the regulator Hence the regulator would then be aware
of the concentrations (with min and max ranges) of ingredients in products on the EU market
and be able to monitor the additives within tobacco products One important issue that this
raises is that of what would be the framework of such a standardised batch or time period
for which the submitter should collect and statistically analyse the final batches It was not
possible to conclude on what would be the ideal reporting period but EUREST suggests that
an annual reporting period may be adequate and accommodate both small and larger batch
production companies without it becoming a burden to regulators
This section also included in coded format an updated version of Table 2 of the current
reporting format which was evaluated to be currently of limited use to regulators due to its
complexity EUREST proposes in light of the above to accommodate an easier checkbox
system for regulators utilising the current model and CLPREACH classifications This would
be complemented by the uploading of complete files on CMR properties which would be
available should the regulator wish to evaluate the toxicity more in depth Within the
toxicological grading we must note that EUREST removed reference to the use of the GRAS
system which refers to the toxicity during ingestion not inhalation
e) TNCO and other emissions (Section 26)
This section of the data dictionary is specific to product emissions The functionality to allow
for TNCO emissions is provided as also the ability for additional emission testing should it
be deemed necessary Emission testing for e-cigarettes and their refill liquids was handled
with detail and was a complex issue due to the absence of testing standards emission
protocols or priority emission constituents to evaluate To address this gap and until a
standard is adopted that meets the EC requirements EUREST proposed that e-cigarette
liquids and products should be tested not on theoretical testbeds or with test bed liquids
but with real market products
With regards to the emissions to be tested for e-cigarettes EUREST proposes that those
constituents which can be tested for in the liquid phase should be tested as such as the
absence of these substances (ie TSNAs ethylene glycol diethylene glycol diacetyl acetyl
propionyl) in the liquid would mean that they would not be identifiable in the emissions
Emission testing in this case would include testing for formaldehyde acetylaldehyde
acrolein heavy and trace metals and total aerosol production These emissions of e-
cigarettes and their refill liquids have the highest relevance to public health via direct or
passive exposure to e-cigarette vapour
f) Domains related to specific products
The data dictionary concludes with domains for specific products An example of information
requested for a specific product include design parameters of cigarettes (filter ventilation
characterising flavour etc) information on pH and nicotine for smokeless tobacco and
information in nicotine content within roll your own tobacco
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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For e-cigarettes this includes a detailed description of design parameters that would aid in
unique product identification and also includes hardware parameters including substantial
information on the voltage wattage and battery parameters which may be potentially
linked under certain conditions to the production of toxic substances It is important to
note that within the reporting format for e-cigarettes parameters related to the declaration
of child and tamper proof status and the related design parameters quality and safety
issues high purity (EU Pharmacopeia standards for nicotine and the diluents) production
conformity and non-risk under normal conditions of use are all requested as detailed in the
data dictionary (ANNEX B) and the technical justification document (Annex C)
63 WP3 Detailed Methods and Results
631 Introduction
The aim of WP3 was to develop the framework for the creation of an efficient platform for
the submission of data from manufacturers or importers to EU MS regulators Hence the
overall scope of WP3 was to develop the necessary files for the implementation of a large
scale submission system and to develop a pilot IT submission platform that could be used
for the submission and handling of such data The overall goal was focused on the fact that
the submission platform should be designed to be secure user friendly and useful to all
partners involved This utility would greatly increase the benefits it could provide to
regulators industry and subsequently to NGOs and EU citizens
632 Methodological Approach
The development of the pilot electronic platform for data submission was based on a well-
established system development lifecycle (SDLC) consisting of the following phases
1 Analysis-inception
2 Design Elaboration
3 Implementation ndash Construction
4 Testing
Analysis ndash Inception
This main scope of this phase was to finalize and to extract the detailed requirements for
the pilot electronic platform Its main purpose in this particular project was to standardize
the information extracted by Work Packages 1 and 2 The gathering of the requirements
was based on workshops interviews and guided discussions targeting to translate the
analysis of WP1 and WP2 to tangible requirements for an electronic platform During this
analysis the following information were collected
The main entities of the application such as the tobacco product electronic
cigarette manufacturer laboratory and ingredient
The use cases that need to be served by the electronic platform along with their
respective actors
Additional functional and non-functional requirements (such as security
requirements)
The outcome of this phase was a document describing the lsquoUse Casesrsquo and a verified lsquoData
Dictionaryrsquo
Design - Elaboration
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The design of the pilot electronic platform included the translation of the requirements as
gathered in the analysis to detailed technical specifications for the final product
The main deliverables of this phase was the lsquoData Modelrsquo and the UI mock-up screens WP3
is substantially based on the variables noted in the data dictionaries as outlined in WP2
taking into account not only their description but also the relationship between variables
For this purpose the Data Dictionaries of WP2 were used as a base on which the Data Model
was developed The EUREST data model organizes the variables of the data dictionary and
standardizes how these data elements relate to each other hence determining the structure
of the presented data
The Data Model document provides a technical representation of how the Database of the
lsquoReporting platformrsquo is structures including the following information Tables Attributes
Constraints Relationships Business Rules
Implementation ndash Construction
This is the phase that the pilot electronic platform was developed according to the design
which was produced during the previous phase Implementation was based on and technical
best practices and standards (such as W3C standards) with the aim to produce a deliverable
that covers all requested requirements
The pilot electronic platform for data submission was developed to provide the following
featuresfunctionalities in summary
Use and profile management for the various stakeholders
Submission and manufacturers management
Products and ingredients management (additive ingredients tobacco ingredients
emissions product presentation sales data review data)
The final deliverable of this phase was the application in draft format the lsquoArchitecturersquo of
the application the lsquoDeploymentrsquo document and the lsquoUser Manualrsquo describing how to
execute the various functionalities provided by the system
Testing
The final stage of the process for creating the EUREST electronic reporting system was the
testing and optimization of the functional product Based on predefined test cases the pilot
product was delivered internally for testing of the various use cases The purpose of this
phase was to ensure the quality of the end-product (Quality of Service - QoS)
The deliverable of this phase was the verified lsquoApplicationrsquo in its official format
64 WP4 Detailed Methods and Results
641 Introduction
WP4 is very closely tied to the previous work packages to the extent that it essentially is
integrated throughout the formulation of the proposed reporting format (WP2) and design
mechanisms of actual data submission and disclosure within the electronic reporting system
(WP3) As previously outlined the overall aim of WP4 was to provide feedback on the
ongoing processes developed within the previous work packages as also to perform a
qualitative cost benefit assessment of the proposed reporting format and submission
mechanism
642 Methodological Approach
EUROPEAN COMMISSION
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Two aspects of research were performed under WP4 The first aspect was to perform a data
collection activity to obtain feedback on draft working versions of the data dictionary from
a convenience sample of ECIS and TIS The second aspect was to perform a basic qualitative
assessment of the cost effectiveness of the proposed solution
With regards to the questionnaire process two structured questionnaires were developed
that included domains on multiple aspects of WP2 and WP3 that included Issues specific to
the proposed draft notification format introduced through Directive 201440EU (Domain
1) evaluation of the administrative and economic impact of implementing the proposed
draft notification format (Domain 2) Issues related to the IT system (Domain 3) and an
area for the submission of other issuescomments (Domain 4)
All communications with stakeholders were performed only in writing via a dedicated email
account and fully documented No communication through any other venue was facilitated
Overall EUREST sent the questionnaire to 19 TIS of which 12 TIS returned a report
completed Moreover EUREST reached out to a convenience sample of 21 ECIS of which
12 ECIS returned a completed report
With regards to the costbenefit analysis approach this was performed through the
combination of stakeholder feedback EUREST expert consultation and a supplementary
review of information available taking into account that a number of aspects of the proposed
data dictionary for which a conclusion cannot be reached would impact the overall cost of
its implementation
643 Synopsis of tobacco industry stakeholder feedback
1 With respect to the reporting of variables under the domain of tobacco types tobacco
part types a significant number of TIS mentioned that the types of tobacco part leaf
types and cure methods are comprehensive with minor addition and suggestions
brought forward
2 With respect to the ingredient quantity fluctuation responses included that either
the ingredient quantities fluctuate substantially in their products while others noted
that they work with specific recipes
3 TIS were asked to define their interpretation of the proposed aspect of a standardized
batch for which ingredient quantities should be measured and then compared with
the quantities reported There was no conclusive response from the stakeholders
with regards to either the size or the timeframe that would define a standardized
batch
4 TIS considered a number of items noted within the data dictionary as trade secrets
with a focus on market and sales data as also certain ingredient information below a
certain cut-off
5 With regards to the administrative and economic impact of implementing the
proposed draft notification format TIS indicated that the redevelopment and
reprogramming of IT systems in order to accommodate new requirements will result
in significantly large development cost
6 All TIS stated that they cannot provide any indication of cost at this stage until the
data dictionary is clearly defined the system and process identified eg the cost
associated with one centralised harmonised system would be significantly less than
multiple portals
7 There were significant different opinions between TIS on the implementation of fees
related to the implementation and adherence to the system
8 With regards to issues related to the submission mechanism TIS deemed that the
following key features are of significant importance to them
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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ndash One centralised IT system with one single authority as the owner of the IT-
system
ndash Security aspects such as Secure Connection Data Segregation Access Control
Process Requirements Electronic Signature
ndash Technical support such as HelpdeskSupport Functions Correction possibilities
Audit Trail Language requirements Speed Adequate bandwidth of the
connection
ndash Utility Acceptance by and within the EU Member States Dissemination of
Information for public purposes etc
644 Synopsis of e-cigarette industry stakeholder feedback
1 The majority of ECIS indicated the broad types and design features of the products
marketed in the EU The types suggested by EUREST where in most cases regarded
as satisfactory It is worth noting that ECIS referred that there are product types
that do not fit within the mentioned categories and they recommend additional
product types that were related to the handling of e-cigarette components that do
not contain liquid but are of more hardware design
2 A significant number of ECIS noted the existence of a plethora of products that which
are identical from a constituent and design perspective which however marketed with
different presentations ECIS corroborated that an ability to register products that
differ only by presentation type would results in efficiency savings
3 Almost all ECIS reported that the e-submission of the annual data and information
would be potentially helpful for them Issues that were requested to take into account
included the needs of SME the timeframe between now and the implementation of
such a reporting system Overall it was noted that if implemented appropriately it
would result in the harmonisation across EU MS in relation to the reporting
requirements enabling a single submission across Member States including only in
one language
4 Regarding the proposed by the EUREST consortium ingredient functions the ECIS
stated that all potential ingredient functions have been included As the table
provided was the generic table for all products a number of the functions were not
applicable to e-cigarettes Discussion was brought forward if the term ldquodiluentrdquo
should be replaced by the term ldquoexcipientrdquo
5 With respect to the emission test product EC-ID a significant number of ECIS
responded that the wording of the approach is understandable but a clarification
should be made about what would be the best- selling product that is used for
testing whether is the best-selling in the EU or the best-selling product in EU for a
particular company This was taken into account in the wording of the relative data
dictionary by EUREST
6 ECIS brought forward a number of aspects related to the emissions protocol and
emission substances that will be assessed for each product It was stated that a
number of potential emission products if not within the e-liquid would subsequently
not be in the emissions (TSNAs impurities) hence ECIS suggested that for those
that can be eliminated and verified to be non-existent in the e-liquid that emission
testing should not be performed Most ECIS brought forward the issue of temperature
as a modulator of emissions Clarifications on some of the proposed emissions were
made which were taken into account during the WP2 feedback process
7 With regards to the emission protocols it was noted that multiple emission protocols
are used by ECIS which would make the reporting of emissions very complex for e-
cigarettes ECIS noted the need to create standards for emission testing
EUROPEAN COMMISSION
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Directorate-General for Health and Food Safety
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8 ECIS responded that there is a range of items in the relative data dictionary for e-
cigarettes and their refill liquids which they regard as confidential and of trade secret
with a focus on those about the description of ingredients contained in products the
emissions as well as sales and market research data in order to mitigate the risk of
disclosure of confidential information Specifically some ECIS also noted that the
composition of flavourings to be considered of intellectual property Threshold levels
for these cut-offs were suggested
9 With regards to the administrative and economic impact of implementing the
proposed draft notification format ECIS indicated that any pharmacokinetic nicotine
uptake study conducted in a clinical setting will result in significantly large
development costs which may be prohibitive for most SME Almost all ECIS stated
that it is too early to provide any estimation about the costs Regarding the
administrative impact ECIS indicated that administrative burden will be significant
based on the detailed level of the information requested
10 With regards to the IT system ECIS deemed that the following key features to be in
significant importance
ndash Centralized system for all EU Member States System with central Ownership and
Management
ndash Data security High protection from unauthorized accesses
Organizationindividual log in and account tracking of submission progress with
a saveable online platform
ndash Correction possibilities Helpdesk functions Language requirements Capability
of CSV XML API spreadsheet and bulk uploading Support for users with queries
related to the IT system
ndash It is worth noting that ECIS indicated to avoid the need for expensive and
complex software and systems considering the needs of small companies
645 Costbenefit analysis
6451 Technical feasibility and sustainability of the funding model
According to the text of the TPD Article 5(8) ldquoMember States may charge manufacturers
and importers of tobacco products proportionate fees for receiving storing handling
analysing and publishing the information submitted to them pursuant to this Articlerdquo While
Article 20(2) outlines that ldquoMember States may charge manufacturers and importers
proportionate fees for receiving storing handling and analysing the information submitted
to themrdquo
With this in mind EUREST performed an exploratory qualitative evaluation of the types of
funding models that could be used to support the regulatory process
Three different types of funding systems were evaluated by EUREST an outline of which is
provided below
a) A flat rate fee system for which the user is subject to a flat rate for usage of the
submission system This flat rate would include all costs related to the handling of the data
as outlined in TPD Art5(8)
b) A staggered fee system relative to the number of products that the
manufacturersubmitter markets in the EU MS While this would be directly proportionate
to the relative ldquouserdquo of the IT system for reporting this approach comes with two main
drawbacks Firstly it may disproportionately impact SME who may have a more diverse
portofolio of products in comparison to larger enterprises This is especially the case for
manufacturers and importers of e-cigarette liquids who based on EUREST research may
EUROPEAN COMMISSION
38
Directorate-General for Health and Food Safety
Health programme
market more than 100 products Secondly this is not proportionate to the market share of
the product and its impact on consumers
c) A staggered fee system according to which the fee paid by each submitter is related to
the overall share of the product type in the market (ie cigarette vs roll your own vs pipe
etc) and proportionate to the percentage share of the product within the product type The
US FDA has implemented such an approach EUREST perceives that such a funding model
would be potentially applicable within EU MS subject to certain prerequisites that include
but may not be limited to the fact that the EU MS would have to obtain detailed information
on the value of the total tobacco market in their MS and be aware of the proportionate
percentage of each industry to the whole While a potentially more complex procedure in
comparison to either a flat rate or staggered system EUREST perceives that a weighted fee
system would be the most appropriate
EUROPEAN COMMISSION
39
Directorate-General for Health and Food Safety
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6452 Administrative burden for national regulators the Commission and non-
industry stakeholders
Administrative burden to national regulators and the Commission would be related to time
needed to handle and process the information through the reporting obligations outlined in
the proposed common reporting format This would potentially translate into increased
personnel time should in depth analyses of the submitted data be performed if submission
of this information would take place under the current status quo as identified in WP1 (a
combination of paper submissions CD-ROMS and EMTOC files) Importantly the above
administrative burden would be substantially less than what is currently requested should a
central submission system be coordinated In light of the above costs that are foreseeable
are those related to the facilitation of an IT system at a national level and include hardware
and software costs as also costs for IT personnel to staff the system Moreover we must
stress that the administrative burden for national regulators and the Commission from the
adoption of a common reporting format and IT submission system is minor compared to the
obtainable benefits for the internal market and public health
6453 AdministrativeCompliance costs for the industry
Through WP4 we performed a limited evaluation of the administrativecompliance costs for
the industry so as to adopt the new TPD for the reporting of ingredients for both large
companies and SMEs While a substantial list of stakeholders (both TIS and ECIS) was
contacted the vast majority noted that the exact administrative and compliance costs for
the industry would be based on the final requirements and hence estimations performed
now would not reflect necessarily the final costs However some key points were noted and
evaluated The overview of the administrative and compliance costs for the industry as
evaluated by EUREST is as follows
There are two main types of costs one related to the one-off costs of setting up of
the system and one related to the recurring costs
One off cost settings included the costs to set up the IT requirements and time
needed to perform the submission both of which were regarded as limited in the
case of a central submission system that could facilitate pdfweb submissions for
SMEs and large system to system XML batch uploading for larger submitters
Aspects that would reduce further the economic burden of stakeholders would be the
use of the following technical aspects suggested by EUREST
o The reporting of a product (identical products) to the system using a product
ID which can be referenced
o The ability to submit under one submission the same products that use only
a different packaging presentation
o The aspect that a number of reported variables for each product may be
common between products of the same submitter (ie toxicity reporting for
ingredients) which should be entered once into the system and then ldquocarried
acrossrdquo the system within the same submitter environment
o Mass xml batch uploading would substantially reduce the coststime for
reporting
Administrative burden issues would be limited and also based on the feedback from
stakeholders as part of WP4 substantially smaller when compared to potential
toxicology andor emission testing The main aspect brought forward here was that
the administrative requirements of each submitter (by number of products markets
etc) would be directly associated with the administrative requirements (in
EUROPEAN COMMISSION
40
Directorate-General for Health and Food Safety
Health programme
timepersonnel) which would include the cost for receiving storing handling
analyzing and publishing of the information per productmanufacturer
For the reporting in particular of ingredients within e-cigarettes and their refill
mechanisms laboratory costs would be a significant aspect of the costs for a
submitter and would be either covered with the use of in-house facilities or the
subcontracting of external laboratories If a submitter was to pursue the
development of an in-house laboratory the setup costs would be larger while
subcontracting of laboratory testing would lead to lower initial however longer
recurring costs for the submitter
Emission testing for the case of e-cigarettes and their refill mechanisms would be
a source of significant cost which would be substantially lower if performed as part
of a liquid analysis Hence potential emission constituents that could be evaluated as
non-existent in the e-liquid may be measured only in liquid form However so as to
protect consumer and public health emissions which may have an impact on health
must be measured for each product on the EU Market
EUREST has proposed the aspect of recipe vs measured quantities within tobacco
products This would allow for the more appropriate monitoring of the change of
constituents within tobacco products and allow for detailed tobacco product
monitoring with potential benefits for the internal market and public health However
the costs related to these reporting requirements would be significantly dependant
on the timeframe and size of each proposed ldquostandardised batch period
6454 Utility of data for the regulators and the EU citizens from a public health
perspective
While the main objective of the new common reporting format is to improve the functioning
of the internal market it also represents important benefits to public health
The key elements of the new reporting format and the electronic data platform which
correspond with the final text of the TPD provide an unprecedented opportunity to increase
the detail of information that is available to the regulators and the general public This
increased information will enable regulators to monitor product development constituents
and toxicity and also will enable people to take informed decisions for both tobacco products
as noted in the current format and e-cigarettes for the first time With these facts in mind
the information to be reported by the industry to regulators would have a significant impact
on European Public Health around the below domains
Regulators and the public would have a clear picture of the potential carcinogenic
mutagenic or reprotoxic (CMR) properties that any constituent may have including their
REACH (19072006) and potential CLP classification (12722008) Should an ingredient
not have any known CMR properties this too will be reported
Regulators and the public above a quantity threshold would for the first time receive
information on the tobacco plant derived constituents of tobacco products This would
include for example further information on the tobacco leaf type the existence of
expanded or reconstituted tobacco
Regulators and the public would be provided with information on product specific
emissions design characteristics that may impact the productrsquos CMR properties
addictiveness or potential characterising flavour(s) As product design playrsquos an
important role in product use and experimentation the monitoring of these design
elements would provide crucial information to regulators implementing EU or national
legislations related to tobacco control
EUROPEAN COMMISSION
41
Directorate-General for Health and Food Safety
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Specific design parameters would be noted for certain tobacco products Due to their
direct association with constituent uptake regulators and the public would benefit from
the understanding
Finally the proposed common reporting format would significantly increase the
information on tobacco product constituents design parameters and characteristics that
if linked appropriately with population based data could lead to a broad range of novel
associations that would fuel tobacco product regulatory science both at a European level
and globally
With regards to e-cigarettes in particular
It would reveal to regulatory authorities the exact ingredients within each marketed
liquid along with information on their potential addictive or toxic characteristics This
knowledge would allow regulators to better evaluate existing and emerging products and
ensure that what is on the market is of high quality composition The general public will
also benefit from greater knowledge of the ingredients of e-liquids
To date knowledge on the emissions of e-cigarettes is limited and identified within
selected reports and scientific manuscripts the results of which may be difficult for
regulators and the public to assess Within the proposed reporting format relevant
emissions (via direct or passive exposure to e-cigarette vapour) are to be provided
As e-cigarettes and their refill liquids constitute an emerging and constantly changing
product category the notification process will give a ldquoheads uprdquo to regulators of new
products about to enter the market that include also information on e-cigarette design
parameters
The above are especially important as the EU is taking a global lead on the regulation of e-
cigarettes Consumers and regulators should therefore be in a position to benefit from the
increased information on this emerging product that will be required
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42
Directorate-General for Health and Food Safety
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7 CONCLUSIONS
Overall the activities performed throughout the current project had the overall aim to
support the development of an EU common reporting format for submission of data on
ingredients contained in tobacco and related products and disclosure of the collected data
to the public
To reach this objective the EUREST consortium applied a number of research methods to
understand the current status quo in the EU to assess aspects that need to be addressed
in a new reporting format and to subsequently develop two central documents the Data
Dictionaries for tobacco products and E-cigarettesrefills respectively These two
documents which were described in detail within this final report and its accompanying
annexes have been designed to be useful to regulators understand stakeholder
requirements be cost effective in adopting the aspects outlined in the TPD and finally to
provide a framework for the disclosure of important information to regulators and the
general public
Moreover within the EUREST project these two data dictionaries were also built into a
functional pilot electronic platform for data submission that was designed to assess the
interrelations between data fields requested so as to ensure that they would be functional
when applied in practice through a commonly designed web portal for the submission of
information
Finally as noted in Article 5(5) of the TPD the Commission shall lay down and if necessary
update the format for the submission and dissemination of the information on ingredients
dissemination to the general public Hence in light of the above the work performed within
the EUREST project may provide input to the work on implementing acts
EUROPEAN COMMISSION
43
Directorate-General for Health and Food Safety
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8 ANNEXES
ANNEX A Data dictionary for the proposed common EU reporting format for
tobacco products
ANNEX B Data dictionary for the proposed common EU notification format for
electronic cigarettes and refill containers
ANNEX C Data dictionary technical justification document
Annex A Data Dictionary for the Proposed Common EU Reporting Format for Tobacco Products
1 Introduction
Objectives of this document
The purpose of this document is to describe the relevant data elements and definitions used in the common reporting format and within the data
model of the submission platform
Reference documents
This section lists the applicable and referenced documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related products
and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleTob
accoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_enpdf Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
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Annex A ndash2
Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value 0 (falsedisabled)
1(trueenabled)
Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
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Annex A ndash3
White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String (80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String (100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Description long Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Tobacco Product
identifier (TP-ID)
Numeric identifier in the form of Submitter number- year-product number NNNNN-NNNN-NNNNN
e 02565-2015-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format NNNNNN Eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N
where N represents integers NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character eg 1A 0 1 2
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
210 Submitter _ID This is the submitter ID it is the first part of the (TP-ID)
String Text M
220 Submitter_Name Official name of the submitter at the MS level as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent company if
it exists is an SME as defined in EU recommendation 2003361
List
element
Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product String Text M
245 Submitter_Type Indication whether the submitter is a
manufacturer or importer
List
element
Dropdown M
250 Submitter_Address The address of the Submitter associated with the
VAT
String Text M
260 Submitter_Country The country of the Submitter in which the company is based
List element
Dropdown M
270 Submitter_Phone The business phone of the Submitter with international codes
String Text Phone M
EUROPEAN COMMISSION
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Annex A ndash5
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company Boolean Checkbox F (it makes all information in 22a below mandatory
2100 Submitter_Has_Subsidiary_company
Checkbox if the submitter has a subsidiary company
Boolean Checkbox F (it makes all information in 22b below mandatoryndash
multiple entries
possible)
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox F (it makes information in 22c mandatory)
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should
one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address
The address of the parent company String Text F
294 Submitter_Parent_Count
ry
The country in which the parent company is based List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
EUROPEAN COMMISSION
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Annex A ndash6
296 Submitter_Parent_Email The business email address of the parent company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter Subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item Field Comments Data Type Control Type
White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the subsidiary company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the subsidiary company String Text F
2103 Submitter_Subsidiary_Address The address of the subsidiary company String Text F
2104 Submitter_Subsidiary_Country The country in which the subsidiary company
is based
List element Dropdown F
2105 Submitter_Subsidiary _Phone The business phone of the subsidiary company
with international codes
String Text Phone F
2106 Submitter_Subsidiary Email The business email address of the subsidiary company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control
Type
White
list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose
behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is
based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company
with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal
company Only functional addresses should be
used
String Text Email F
EUROPEAN COMMISSION
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Annex A ndash8
23 Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a
complete list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the system when the user submits the product Date will have the following format ddmmyyyy
Date System Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action that would lead to a change of the TP-ID version
Date System Generated
AUTO
310 Tobacco_Product ID (TP-ID) The unique TP-ID is given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NNNN-
NNNNN) ldquosubmitter ID numberrdquo is the ID of the Submitter
as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported
ldquonumberrdquo is a unique number given to each product by the submitter when first reported
String Text TP-ID M (following the specified
rules)
314 Tobacco_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If
checked then Item 315 become mandatory
Boolean Checkbox M
315 Tobacco_Product_ID_Other Additional ldquoProduct_TP_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other Product_TP_IDs exist for this identical
String Text F
EUROPEAN COMMISSION
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Annex A ndash9
product in other MS Each additional TP_ID is separated with semicolons ()
320 Product_Type The type of tobacco product concerned See Table 32 of the Reference Data section which provides a complete list of types
List element Dropdown M
330 Product_Length Average length of the product unit in mm Decimal Text F (M for cigars cigarillos and
cigarettes)
331 Product_Diameter Average diameter (measured at the point with maximal diameter) of the product unit in mm
Decimal Text F (M for cigars cigarillos and cigarettes)
332 Product_Weight Weight of one unit of product including the specified
moisture for one unit of product and expressed in
mg
Decimal Text M
333 Product_Tobacco_Weight Weight of the tobacco in one unit of the product a
unit of product is one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all
loose products is 1 g including the moisture content and expressed in mg
Decimal Text M
375 Product_Manufacturer_Identification
If the submitter is NOT the manufacturer of the tobacco product then here he would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F (M if submitted by an importer)
385 Product_Production_Multipl
e_Sites
Dropdown if the product in the current presentation is
produced in multiple sites
List element Dropdown M
386 Product_Production_Site_Address
The complete address of the sites where product production is completed
String Text M
EUROPEAN COMMISSION
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Annex A ndash10
340 Product_Technical_File Pdf file as the relative technical document setting out a general description of the additives used and their properties
File File browser
F (M for cigarettes and RYO tobacco)
341 Product_Filter Existence of a filter in the product Boolean Checkbox M
342 Product_Filter_Length Length of the product filter in mm Decimal Text F
23 Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the MS String Text Descrip
tion Long
M
322 Product_Brand_subtype_name
The product ldquosubtype namerdquo as marketed in the MS String Text Description Long
M
323 Tobacco
Product_launch_date
Date on which the submitter plans to launchlaunched
the product on the market
Date text M
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form
The picture should be clear enough to view details and aid in unique product identification
File File
browser
M
EUROPEAN COMMISSION
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Annex A ndash11
391 Product_Package_ Picture_File
The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser
O
360 Product_Multiple_Presentation
A dropdown if the unique TP-ID product is marketed with different presentations This is the ldquokeyrdquo to product description Part B
List element Dropdown M
370 Product_internal_Number The Internal manufacturing ID used by the company
for recognition of the product
String Text M
At least one must be reported consistently for ALL submissions
made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
374 Product_SKU_Number The SKU (Stock Keeping Unit) number(s) for the product
String Text
380 Product_National_Market The Member state for which the product information below is being provided The EU MS is selected from a dropdown list
List element Dropdown M
390 Product_Package_Type The type of the Product Package as described from the dropdown of the reference Table 33
List element Dropdown M
3100 Product_Package_Units The number of individual units of product in the package
Decimal Text F (M for cigarettes cigars cigarillos and SLT -only if the SLT
package contains individual units ie bits or pouches)
3105 Product_Package_Net_Weight
Net Weight of the product contained within one
package in g
Decimal Text F (M for SLT (if it is loose) finecut RYO
EUROPEAN COMMISSION
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Annex A ndash12
and waterpipe tobacco)
3110 Product_Maximum_Sales_Price
The highest (maximum) retail sale price per package of the specific product in the local currency in the country for which the product is being reported
Decimal Text O
3115 Product_Sales_Volume Information on annual sales volume of the reported
product in the country at the submitter level To be
reported in sticks for cigarettes cigars and cigarillos
or in kilograms for oral and fine cut tobacco
Decimal Text M
3120 Product_Other_Market_Data Other market data that may be available to the submitter
String Text O
3130 Product_Market_Research_File
The relevant pdf document of internal and external studies on market research and preferences of various
consumer groups including young people and current smokers relating to ingredients and emissions as well as executive summaries of any market surveys they
carry out when launching new products if available to the submitter
File File browser
M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash13
24 Description of Ingredients Tobacco
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product
or related products including paper filter ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco ingredientrdquo used
in the product similar to how other ingredients are reported
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
410 Tobacco_Part_Type The type of tobacco part as noted in Table 34 of the Reference Data section Each specific type should be reported separately
List element
Dropdown M
411 Tobacco_Part_Type_Other The name of the tobacco part type if ldquootherrdquo is selected from Table 34 of the Reference Data Section
String Text F
412 Tobacco_Part_Description_File Pdf including the overall description of the manufactured part type in the recipe The description should provide detailed information on the quantitative and qualitative consistency of the manufactured tobacco
File File browser
F if Item 410 2 3 or 4
413 Tobacco_Part_Manufactured_Source
The manufacturersource of the manufactured tobacco Manufactured tobacco from multiple sources
must be reported separately one by one
String Text F Item 410 is 2 3 or 4
420 Tobacco_Leaf_Type The type of tobacco leaf used See Table 35 of the Reference Data section which provides a complete list
of tobacco leaf types
List element
Dropdown M
421 Tobacco_Leaf_Type_Other The name or description of the tobacco leaf type if ldquootherrdquo or ldquounspecifiedrdquo is selected from Table 35 of the data reference section
String Text F
430 Tobacco_Leaf_Cure_Method The method used to cure the tobacco leaf See Table
36 of the Reference Data section for a complete list
List
element
Dropdown M
431 Tobacco_Leaf_Cure_Method_Other
The namedescription of the cure method used if ldquootherrdquo is selected from Table 36 of the Reference Data section
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash14
440 Tobacco_Quantity The quantity of each of the tobacco parts noted in Item 410-420-430 Reported per product unit in mg This variable should be the weight of tobacco by
leaf cure method leaf type and part type
Decimal Text M
25 Description of ingredients Additives and other substanceselements
Note As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any substance or element present in a finished tobacco product or
related products including paper filter ink capsules and adhesivesrdquo
Item
Field Comments Data Type Control Type
White list
Reporting Visibility
510 Ingredient_Category Category of the product component or material to which the ingredient is added to as described in
Table 37 of the Reference Data section
List element
Dropdown M
511 Ingredient_Category_Other The category of the product component or material to which the ingredient is added in text format if
the response to Item 510 is ldquootherrdquo
String Text F (M if response to
Item510 is ldquootherrdquo)
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers provided For
each additional CAS number provided to the
system the system will provide a field for an
additional CAS (up to 10 additional CAS can be
uploaded)
String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash15
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers Association
(FEMA) 4 digit reference number of ingredient if
one has been granted for the ingredient In the
case of multiple FEMA numbers they are to be
separated by semicolons ()
String Text FEMA identifier
F
If a CAS
does not exist reporting at least one is mandatory and to be
reported in the following order of importance FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food additive
number should be stated using the ldquoE numberrdquo
noted in Commission Regulation (EU) No
11302011 and Regulation (EC) No 13332008
String Text Food Additiv
e
Identifier
525 Ingredient_FL_Number European flavouring (FL) number of ingredient if
one has been granted for the ingredient based on
the commission Implementing Regulation (EU) No
8722012
String Text FL identifi
er
526 Ingredient_EC_Number European Community (EC) number if one has been
granted for the ingredient (This is also known as
the EC No EINECS No and EC)
String Text EC identifi
er
530 Ingredient_Quantity_Fluctuate Declaration that the ingredient quantity does
fluctuate A response of YES would make items 550 551 552 553 mandatory
Boolean Checkbox M
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one unit of product in mg according to recipe Ingredients should be listed for each category mentioned in
Item 510 above preferably in descending order of weight
Decimal Text M
541 Ingredient_Recipe_Min_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare lowest range in weight (mg) of the specific ingredient in one unit of the product This used weight should NOT be lower
Decimal Text F (M if 530 is Yes)
EUROPEAN COMMISSION
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Health programme
Annex A ndash16
542 Ingredient_Recipe_Max_Level When the declared quantity of the additive fluctuates in order to adjust for the natural variations of tobacco leaf the manufacturer should
declare the upper range in weight (mg) of the specific ingredient in one unit of the product This weight should NOT be exceeded This field can be used to differentiate the ingredient information below into either ldquoConfidentialrdquo or ldquoPublicrdquo on the basis of agreed cut-offs
Decimal Text F (M if 530 is Yes)
550 Ingredient_Measured_Mean_Qu
antity
The measured mean (average) weight of the
ingredient in mg that was added to one unit of the product during the previous reporting period This ldquoMeasured Mean Quantityrdquo is to be calculated based on the average of the quantity of that ingredient added within each standardised batch
Decimal Text F (M if
530 is Yes)
551 Ingredient_Measured_SD The statistically derived standard deviation of the mean quantity of ingredient added to one unit of the product within each standardized batch during the previous reporting period
Decimal Text F (M if 530 is Yes)
552 Ingredient_Measured_Min_Leve
l The measured (actual) lower value of the quantity
of that ingredient added to one unit of the product
within each standardized batch during the previous
reporting period This corresponds with the
minimal value recorded
Decimal Text F (M if
530 is
Yes)
553 Ingredient_Measured_Max_Level
The measured upper value of the weight quantity
of that ingredient included during the previous
reporting period This corresponds with the
maximal value recorded during the previous
reporting period
Decimal Text F (M if 530 is Yes)
560 Ingredient_Function Function of the ingredient The ingredient functions
are given in Table 38 of the Reference Data section with their code and definition If an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash17
561 Ingredient_Function_Other The function of the ingredient in text format if the response to Item 560 is ldquootherrdquo
String Text F
570 Ingredient_Priority_Additive Indication if the ingredient is a priority additive (Responses include Yes no not published yet) Until the ldquoPriority additive listrdquo of the TPD is provided all responses shall be noted as ldquonot published yetrdquo
List element
Dropdown M
571 Ingredient_Priority_Additive_Fil
es
Pdf files of the report which shall include an
executive summary and a comprehensive overview compiling the available scientific literature on that additive and summarising internal data on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo
File File
browser
F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if the
ingredient in unburnt status is characterised by any
known type of toxicity or has CMR properties
Selection to be defined as in Table 39
List element
Dropdown M
590 Ingredient_REACH_Registration Notification if the ingredient has been registered
under REACH (19072006) regardless of its registration type REACH status can be identified via the public domain through the site httpechaeuropaeuinformation-on-chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List
element
Dropdown M
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-chemicalscl-inventory-database
List
element
Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash18
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
F based on response to 5109
Reminder all fields that are flagged with a symbol (ie M or
F) are
automatically completed by the system once submitted for the first
time by the manufacturer
5111 Ingredient_CLP_Acute_Tox_Der
mal
Ingredient Classification with regards to acute
dermal toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5112 Ingredient_CLP_Acute_Tox_Inhalation
Ingredient Classification with regards to acute inhalation toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_Sensitisation
Ingredient Classification with regards to respiratory sensitisation based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisation
Ingredient Classification with regards to skin sensitisation based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5117 Ingredient_CLP_MutagenGenotox
Ingredient Classification with regards mutagenicitygenotoxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008
List element
Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008
List element
Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash19
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are selected from the
dropdown list provided
List element
Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox Ingredient Classification with regards to aspiration
toxicity based on Regulation (EC) No 12722008
List
element
Dropdown Tox_C
ode
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in burnt or unburnt form See Table 310 of the Reference Data section for potential responses
List element
Dropdown M
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate pyrolytic breakdown and
intact transfer of an ingredient to smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including but
not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient
on the reproductive system and its potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the product (The analyses should be based on
Boolean Checkbox FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash20
either inhalation or dermal exposure for the latter)
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to evaluate
the toxicological effects of the ingredient on the
heart blood vessels or respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated
above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will
be available
File File browser
FM
26 TNCO and other emissions
Note These variables are not mandatory for all tobacco products
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
610 Emission_Tar For cigarettes Tar according to the ISO standard 4387 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
611 Emission_Nicotine Nicotine yield according to the ISO standard 10315
with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
612 Emission_CO CO yield according to the ISO standard 8454 with the accuracy measurements determined in accordance with ISO standard 8243
Decimal Text F (M for cigarettes)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash21
620 Emission_TNCO_Lab The identification of the laboratories used to measure each of the above TNCO emissions from the list of the laboratories used by manufacturers and
communicated to the commission In case of multiple entries they should be separated by semi- columns ()
String Text F (M for cigarettes)
630 Emission_Other_Available Filter variable for notification of the existence or not
of information on other emissions and their levels
List element
Dropdown
M
631 Emission_Methods_File Pdf file on the production and measurement methods
used to assess the emissions The file should contain
substantial information for the regulator to
understand and duplicate if necessary the emission
test and also include where the emission testing took
place
File File
browser
F
640 Emission_Name Chemical name of the emissions produced during the
testing of the product
String Text F
641 Emission_CAS The individual emissionrsquos Chemical Abstract Service
(CAS) registry number
CAS
Identifie
r
F
642 Emission_IUPAC The emissionrsquos IUPAC name should a CAS number
not exist
String Text F
643 Emission_Quantity The quantity of the emission produced during the
process of using the product
Numeric Text F
644 Emission_Units The units in which the emission is measured String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash22
27 Cigarette specific
The following information in 27 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquocigaretterdquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
710 Cigarette_Characterising_Flavour Classification of the cigarette as having a characterising flavour (Y vs N)
Boolean Checkbox M
722 Cigarette_Filter_Ventilation Total Ventilation of the filter (0-100) Integer Text M
723 Cigarette_Filter_Drop_Pressure_Closed
Drop of Pressure with closed vents (mmH2O) Decimal Text M
724 Cigarette_Filter_Drop_Pressure_Open Drop of Pressure with open vents (mmH2O) Decimal Text M
28 Smokeless (Oral-nasal-chewing) specific
The following information in Section 28 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoOral tobaccordquo OR ldquoNasal tobaccordquo
OR ldquoChewing tobaccordquo
Item
Field Comments Data Type
Control Type
White list
Reporting Visibility
810 Smokeless_pH The pH of the product Decimal Text M
820 Smokeless_Total_Moisture Total moisture of the product per unit Decimal Text O
830 Smokeless_Nicotine_Content Total nicotine content of the product per unit Decimal Text M
840 Smokeless_Unionised_Nicotine_Content Unionised nicotine content of the product per unit Decimal Text O
850 Smokeless_Analysis_Methods Brief Text description of the methods used to measure the above variables including references to more detailed information on the approach
String Text O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash23
29 Novel Tobacco Products
The following information in 29 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoNovel tobacco productrdquo
Ite
m
Field Comments Data
Type
Control
Type
White
list
Reporting Visibility
910 Novel_ Risk
Benefit_File
Pdf file on the RiskBenefit analysis of the product its
expected effects on cessation of tobacco
consumption its expected effects on initiation of
tobacco consumption and predicted consumer
perception
File File
browser
O (M if the
submitter uses
this system to
report their
product)
920 Novel_Contain_Tobac
co
Identification if the novel tobacco product contains
tobacco
Boolea
n
Checkbo
x
O (M if the
submitter uses
this system to
report their
product)
210 Fine cut - Pipe tobacco specific
The following information in Section 210 is applicable only for products that have the ldquoProduct typerdquo (Item 320) to ldquoFinecutrdquo OR ldquoPipe Tobaccordquo
Field Field Comments Data
Type
Control
Type
White
List
Reporting Visibili
ty
1010 Finecutpipe_Total_Nicotine_Content Total Nicotine content of the
loose product per unit
Decimal Text M
1020 Finecutpipe_Unionised_Nicotine_Con
tent
Unionised nicotine content of
the loose content
Decimal Text O
EUROPEAN COMMISSION
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Annex A ndash24
212 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables included in the above tables based on their reporting requirements
as outlined in the TPD ndashhence no other specific wording terminology will be applied These include cigars cigarillos water pipe tobacco amp herbal products
3 Reference Data
31 Type of submission
32 Product Type
Value Name
1 Cigarette
2 Cigar
3 Cigarillo
4 Roll your own tobacco
5 Pipe tobacco
6 Waterpipe tobacco
7 Oral tobacco
8 Nasal tobacco
9 Chewing tobacco
15 Herbal product for smoking
16 Novel tobacco product
Value Name
1 New product submission including a submission of a product modification in declared recipe or design (New TP-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of TP-ID
version)
3 Submission of new informationdata on an existing product leading to a modificationaddition at the level of product presentation
(Update of TP-ID version)
4 Cancellation
EUROPEAN COMMISSION
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Health programme
Annex A ndash25
33 Product Package
Value Name
1 Flip top box square corner
2 Flip top box bevel corneroctagonal
3 Flip top box rounded corner
4 Shoulder hinged box
5 Soft pack
6 Pouch with flap
7 Bucket (Cylindrical or cuboid)
8 Cuboid can
9 BlockFoil pack
10 Cylinder cardcan
11 Standing pouch
12 Folding box
13 Carton box
14 Hinged box
15 Hinged tin
16 Flip top pack
17 Single tube tin
18 Bundle
19 Multi cigar tube
20 Cylinder tin
21 Round tin
22 Standing pouch roll-fold
23 Slide lid box
24 Flow wrap
25 Folding pouch
26 ShellHull amp Slide box
27 Multi-pack display
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash26
34 Tobacco Part Type
35 Tobacco Leaf type
36 Tobacco Leaf Cure Method
Value Name
1 Air
2 Fire
3 Steam
4 Sun
5 Flue
6 Other
Value Name
1 Tobacco leaf
2 Manufactured ndash Cut stems
3 Manufactured - Reconstituted tobacco
4 Manufactured - Expanded tobacco
5 Other
Value Name
1 Virginia
2 Burley
3 Oriental
4 Maryland
5 Kentucky
6 Dark
7 Other
8 Unspecified (less than 30 is identifiable to one leaf type)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex A ndash27
37 Ingredient Category
Value Name
1 tobacco (burnt)
2 Tobacco (unburnt)
3 paper (burnt)
4 side seam adhesive (burnt )
5 inks used on cigarette paper (burnt)
6 filtration material (unburnt)
7 filter overwrap (unburnt)
8 filter adhesive (unburnt)
9 tipping paper and tipping paper inks (unburnt)
10 Adhesive (unburnt)
11 Adhesive (burnt)
12 tips (unburnt)
13 Pouch material (unburnt)
14 paper (unburnt)
15 Other (unburnt)
38 Ingredient Function
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
EUROPEAN COMMISSION
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Annex A ndash28
39 Ingredient Unburnt Status
310 Toxicological Data Available
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B - 1
Annex B Data Dictionary for the Proposed Common EU Notification Format for Electronic Cigarettes and Refill Containers
1 Introduction
11 Objectives of this documents
The purpose of this document is to describe the relevant data elements and definitions used in the proposed common reporting format and within
the data model of the submission platform
12 Reference documents
Ref Name
Available from httpeur-lexeuropaeulegal-
contentENTXTuri=OJL2014127TOC Directive 201440EU of the European Parliament and of the Council of 3 April 2014 on
the approximation of the laws regulations and administrative provisions of the Member
States concerning the manufacture presentation and sale of tobacco and related
products and repealing Directive 200137EC
httpeceuropaeuhealthph_determinantslife_styleT
obaccoDocumentspractical_guidance_enpdf Reporting on tobacco product ingredients PRACTICAL GUIDE
httpechaeuropaeudocuments1016213562clp_en
Guidance on the Application of the CLP Criteria Guidance to Regulation (EC) No
12722008 on classification labelling and packaging (CLP) of substances and mixtures
Version 40 November 2013
httpeur-lexeuropaeulegal-
contentENTXTPDFuri=CELEX32008R1272ampfrom=EN
Regulation (EC) No 12722008 Of The European Parliament And Of The Council of 16
December 2008 on classification labelling and packaging of substances and mixtures
amending and repealing Directives 67548EEC and 199945EC and amending
Regulation (EC) No 19072006
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -2
13 Explanation of the data types
Definition of the data types used in this dictionary
Name Definition Example
String Alphanumeric values limited to 1000 characters Abcd 1234
Decimal Number values decimal allowed 1 22 333
Integer Rounded number values no decimal numbers 1 22 333
File Files as provided in pdf form XXXXXpdf
Date Text corresponding to the following format DDMMYYYY
22032012
List element Must be only one of the values present in the Values column
Boolean Boolean value A pop up box asking for a tick-box for yes
0 (falsedisabled) 1(trueenabled)
14 Reporting types
There are multiple types of mandatoryoptional fields in the current system as noted in the table below
Type Explanation
System generated (AUTO) The variables are automatically generated by the software system in each MS
Mandatory (M) These variables must be completed to successfully submit the report
Optional (O) These are to be completed on an optional basis to aid product reporting
Filter Mandatory (F) These become mandatory if a specific response is selected from an above variable (eg product type)
M F These are AUTOMATICALLY COMPLETED once the manufacturer completes it for one ingredient This is
information that is not product specific
CP This defines if the variable will be presented as public or as confidential based on predefined cut-offs
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -3
15 White lists
The following table contains certain white lists used for the validation of fields
Data Type Description Regular expression
Phone
Numeric characters Plus sign left parenthesis right parenthesis full stop Maximum 20 characters
[[0-9][+] [()]]
Email String(80) ^[_a-z0-9-]+([_a-z0-9-]+)[a-z0-9-]+([a-z0-9-
]+)(([a-z]23))$
Name String(100)
Identifier Numeric with no decimal characters (Maximum 10 digits)
Descriptionlong Alphanumeric maximum 1000 characters
Submitter ID Numeric identifier provided to the submitter of the data by the Administrative center
Five digit identifier eg 02565
Electronic cigarette
identifier (EC-ID)
Numeric identifier in the form of Submitter number- year after 2000-product number NNNNN-NN-NNNNN
e 02565-15-00230
UPCidentifier 12 Digit Numeric
EANidentifier Up to 13 Digit Numeric
SKU identifier Numeric
GTINidentifier Numeric
CAS identifier Numeric
FEMA identifier 4 digit Numeric with the following format NNNN NNNN
Food Additive
identifier
5 digit Alphanumeric eg E1402 or E160
FL identifier 7 digit numeric with the following format
NNNNNN eg 13093 or 09933
EC identifier Unique 7 digit identifier written as NNN-NNN-N where N represents integers
NNN-NNN-N
Tox_Code Maximum 2 digits One numeric one capital character
eg 1A 0 1 2
EUROPEAN COMMISSION
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Annex B - 4
2 Data Dictionary
21 Application User Characteristics
Once the submitter has been authorised and approved through an offline procedure heshe will be provided with the necessary information to log
on to the reporting platform
22 Submitter characteristics
The submitter is either the manufacturer or importer responsible for the submitted data
Item
Field Comments Data Type Control Type White list
Reporting Visibility1
210 Submitter _ID This is the submitter ID it is the first part of the (EC-ID)
String Text M
220 Submitter Name Official name of the submitter at the MS level
as linked to the VAT number requested below
String Text M
230 Submitter_SME Verification if the Submitter or parent
company if it exists is an SME as defined in EU recommendation 2003361
List element Dropdown M
240 Submitter_VAT The VAT number of the Submitter of the product
String Text M
241 Submitter_Type Indicate whether the submitting company is a manufacturer or importer
List element Dropdown M
250 Submitter_Address The address of the Submitter associated with
the VAT
String Text M
1The column ldquovisibilityrdquo would indicate whether the submitter considers the data confidential (Public vs Confidential)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -5
260 Submitter_Country The country of the Submitter in which the company is based
List element Dropdown M
270 Submitter_Phone The business phone of the Submitter with
international codes
String Text Phone M
280 Submitter_Email The business email address of the Submitter Only functional addresses should be used
String Text Email M
290 Submitter_Has_Parent_Company
Checkbox if the submitter has a parent company It makes all information in 2b below
mandatory
Boolean Checkbox M
2100 Submitter_Has_Subsidiary_Company
Checkbox if the submitter has a subsidiary company It makes all information in 2c below mandatoryndash multiple entries possible
Boolean Checkbox M
2110 Submitter_Appoints_enterer Checkbox if the submitter has appointed a third party to submit its data on its behalf (enterer)
Boolean Checkbox M
22A ManufacturerImporter Parent company characteristics
Note This information is requested once Item 290above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
291 Submitter_Parent_ID The Submitter ID of the parent company should one exist
String Text F
292 Submitter_Parent_Name Official name of the parent company String Text F
293 Submitter_Parent_Address The address of the parent company String Text F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -6
294 Submitter_Parent_Country The country in which the parent company is based
List element Dropdown F
295 Submitter_Parent_Phone The business phone of the parent company with international codes
String Text Phone F
296 Submitter_Parent_Email The business email address of the parent
company Only functional addresses should be used
String Text Email F
22B ManufacturerImporter subsidiary company characteristics
Note This information is requested once Item 2100 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2101 Submitter_Subsidiary_ID The Submitter ID of the affiliate company
should one exist
String Text F
2102 Submitter_Subsidiary_Name Official name of the affiliate company String Text F
2103 Submitter_Subsidiary_Address The address of the affiliate company String Text F
2104 Submitter_Subsidiary_Country The country in which the affiliate company is based
List element Dropdown F
2105 Submitter_Subsidiary_Phone The business phone of the affiliate company with international codes
String Text Phone F
2106 Submitter_Subsidiary_Email The business email address of the affiliate company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -7
22C Enterer reporting on behalf of the submitter
Note This information is requested once Item 2110 above is checked as ldquoYesrdquo This would open the following data variables
Item
Field Comments Data Type Control Type White list
Reporting Visibility
2201 Submitter_Principal_ID The Submitter ID of the company on whose behalf the submission takes place (so called
Principal)
String Text F
2202 Submitter_Principal_Name Official name of the principal company String Text F
2203 Submitter_Principal_Address The address of the principal company String Text F
2204 Submitter_Principal_Country The country in which the principal company is based
List element Dropdown F
2205 Submitter_Principal_Phone The business phone of the principal company with international codes
String Text Phone F
2206 Submitter_Principal_Email The business email address of the principal company Only functional addresses should be used
String Text Email F
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -8
23A Product Submission and Description ndash Part A
Item
Field Comments Data Type Control Type White list
Reporting Visibility
301 Submission_Type The type of submission for the product See Table 31 of the Reference Data section which provides a list of the possible actions types
List element Dropdown M
303 Submission_Start_Date The submission date will be calculated by the
system when the user submits the product Date will have the following format ddmmyyyy
Date System
Generated
AUTO
304 Submission_End_Date The date between two versions of the same product This date will be generated by the system whenever the user performs an action
that would lead to a change of the EC-ID version
Date System Generated
AUTO
310 E-Cigarette_ID (EC-ID) The unique EC-ID given to each product It is proposed to be in the format of ldquoSubmitter ID
number- year- product numberrdquo (NNNNN-NN-
NNNNN)
ldquosubmitter ID numberrdquo is the ID of the Submitter as is provided centrally by the administrative office
ldquoyearrdquo is that within which the product was first reported (2 digits)
ldquonumberrdquo is a unique number given to each
product by the submitter when first reported
String Text EC-ID AUTO
314 E-cigarette_Product_ID_Other_Exist
Notification if the submitter is aware of another product with identical design and recipe that is marketed in the EU using a different TP-ID If checked then 315 become mandatory
Boolean Checkbox M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -9
315 E-cigarette_Product_ID_Other Additional ldquoProduct_EC_IDrdquo fields for when the same product (same recipe and design characteristics) is marketed in another EU MS The submitter reports which other
Product_EC_IDs exist for this identical product in other MS Each additional EC_ID is separated with semicolons ()
String Text F
320 Product_Type The type of e-cigarette or refill liquid concerned See Table 32 of the Reference
Data section which provides a list of product
types
List element Dropdown M
325 Product_Weight_E-liquid Total weight of e-liquid in one product unit in
mg
Decimal Text M
326 Product_Volume_E-liquid Total volume of e-liquid in one product unit in
ml
Decimal Text M
375 Product_Manufacturer_Identifi
cation
If the submitter is NOT the manufacturer of the
product then here they would state the official company name of the manufacturer of the product and other information that would aid the identification of the manufacturer Should multiple companies produce the same product this should be described
String Text F if
submitted by an importer
350 Product_Unit_Picture_File The relevant picture of the individual unit in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
385 Product_Production_Multiple_S
ites
Dropdown if the product in the current
presentation is produced in multiple sites
List element Dropdown
386 Product_Production_Site_Address
The address of the sites where product production is completed This Item is repeated for each product production site
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -10
23B Product Submission and Description ndash Part B
Based on the number of multiple presentations reported in Item 360 the following variables are requested for each individual presentation For instance
if a company reports that they have 5 types of presentation for a product then the table below would be completed five times once for each type of
presentation
Item
Field Comments Data Type Control Type White
list
Reporting Visibility
321 Product_Brand_Name The ldquoproduct brand namerdquo as marketed in the
MS
String Text Descript
ionLong
M
322 Product_Brand_Subtype_name
The product ldquosubtype namerdquo (if one exists) as marketed in the MS
String Text DescriptionLong
M
360 Product_Multiple_Presentation A dropdown if the unique EC-ID product is marketed with different presentations This is
the ldquokeyrdquo to product description Part B (the
ldquothirdrdquo level of detail)
List element Dropdown M
361 E-cigarette_launch_date The date on which the submitter plans to
launchlaunched the product on the market
Date Text M
370 Product_Manufacturer_Number
The internal manufacturing ID used by the company for recognition of the product
String Text M At least one must be reported consistently for ALL
submissions made by a single submitter
371 Product_UPC_Number The UPC-12 (Universal Product Code) for the product
String Text
372 Product_EAN_Number The EAN-13 or EAN-8 (European Article
Number) for the product
String Text
373 Product_GTIN_Number The GTIN (Global Trade Identification Number) for the product
String Text
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -11
374 Product_SKU_Number The SKU (Stock Keeping Unit) number for the product
String Text
380 Product_National_Market The Member state for which the product
information below is being provided
List element Dropdown M
391 Product_Package_Picture_File The relevant picture of the package in pdf form The picture should be clear enough to view details and aid in unique product identification
File File browser M
3100 Product_Package_Units The number of individual units of product in the
package
Decimal Text M
3102 Product_CLP_Classification Overall Product classification as a mixture of
substances based on Regulation (EC) No
12722008 and as described in the ldquoGuidance
on the Application of the CLP Criteriardquo This
takes into account collectively the potential
toxicity at the ldquoproduct levelrdquo
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -12
23C Product Submission of annual data ndash Part C
Item
Field Comments Data Type Control Type White list
Reporting Visibility
3106 Product_Annual_Reporting_Section
Verification if the submitter would like also to
submit their annual information noted in TPD
Art207 via the current submission system
Checking this box activates the below
reporting requirements
Boolean Checkbox F
3115 Product_Sales_Volume Information on annual sales volume of the
reported product in the country at the
submitter level Sales volume reporting to be
reported in pieces (for devices) andor ml (for
e-liquids)
Numeric Text F if 3105 is yes
3117 Product_Mode_Of_Sales Relevant pdf document describing the mode
of sale of the products
File File browser F if 3105 is yes AND
3125 is Option 3
3120 Product_Other_Market_Data Supplementary market data that may be available to the submitter
String Text F if 3105 is yes
3125 Product_Market_Research_Available
Existence of market data available See Table 33 of the Reference Data section for responses
List element Dropdown F if 3105 is yes
3130 Product_Market_Research_File The relevant pdf document of information on the preferences of various consumer groups
including young people non-smokers and the main types of current uses and if available
to the submitter executive summaries of market surveys carried out in respect of any of the fields in this section
File File browser F if 3105 is yes AND
3125 is Option 3
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -13
24 Description of ingredients contained in the product
Item
Field Comments Data Type Control Type White list Reporting
Visibility
520 Ingredient_Name Chemical name of the ingredient String Text M
521 Ingredient_CAS The CAS registry number used to identify the ingredient
String Text CAS Identifier
M
522 Ingredient_CAS_Additional The additional CAS registry numbers
provided For each additional CAS number
provided to the system the system will
provide a field for an additional CAS (up to 10
additional CAS can be uploaded)
String Text F
523 Ingredient_FEMA_Number Flavour and Extract Manufacturers
Association (FEMA) 4 digit reference number
of ingredient if one has been granted for the
ingredient In the case of multiple FEMA
numbers they are to be separated by
semicolons ()
String Text FEMA identifier
If a CAS does not exist reporting
at least one is
mandatory and to be reported in the following order of
importance
FEMAgtAdditivegtFLgtEC
524 Ingredient_Additive_Number If the ingredient is a food additive its food
additive number should be stated using the
ldquoE numberrdquo noted in Commission Regulation
(EU) No 11302011 and Regulation (EC) No
13332008
String Text Food Additive Identifier
525 Ingredient_FL_Number European flavouring (FL) number of
ingredient if one has been granted for the
ingredient based on the commission
Implementing Regulation (EU) No 8722012
String Text FL identifier
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -14
526 Ingredient_EC_Number European Community (EC) number if one
has been granted for the ingredient (This is
also known as the EC No EINECS No and
EC)
String Text EC identifier
540 Ingredient_Recipe_Quantity The weight of the ingredient included in one
unit of product in mg according to recipe Ingredients should be listed in descending order of weight
Decimal Text M
560 Ingredient_Function Function of the ingredient The ingredient
functions are given in Table 34 of the Reference Data section with their code and definition The function code as given in Table 34should be stated here and if an ingredient has multiple functions all the function codes should be stated and are to be separated by semicolons ()
Multivalue Dropdown M
561 Ingredient_Function_Other The function of the ingredient in text format if
the response to Item 560 is ldquootherrdquo
String Text F
580 Ingredient_Unburnt_Status Dropdown on the existence of information if
the ingredient in unburnt status is
characterised by any known type of toxicity
or has CMR properties Selection to be
defined as in Table 35
List element Dropdown M
590 Ingredient_REACH_Registration
Notification if the ingredient has been registered under REACH (19072006) regardless of its registration type REACH
status can be identified via the public domain through the site httpechaeuropaeuinformation-on-
chemicalsregistered-substances
Responses Yes Full Yes Intermediate Yes NONS No not registered
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -15
5100 Ingredient_CLP_Classification Notification if the ingredient has been CLP classified (12722008) and is in the CampL Inventory (A yes vs no response) Available at httpechaeuropaeuinformation-on-
chemicalscl-inventory-database
List element Dropdown M
5110 Ingredient_CLP_Acute_Tox_Oral
Ingredient Classification with regards to acute oral toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code F based on response to 5109
5111 Ingredient_CLP_Acute_Tox_Dermal
Ingredient Classification with regards to acute dermal toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5112 Ingredient_CLP_Acute_Tox_In
halation
Ingredient Classification with regards to acute
inhalation toxicity based on Regulation (EC) No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5113 Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient Classification as a skin corrosiveirritant based on Regulation (EC) No 12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5114 Ingredient_CLP_Eye_DamageIrritation
Ingredient Classification as responsible for eye damageirritation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5115 Ingredient_CLP_Respiratory_S
ensitisation
Ingredient Classification with regards to
respiratory sensitisation based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5116 Ingredient_CLP_Skin_Sensitisa
tion
Ingredient Classification with regards to skin
sensitisation based on Regulation (EC) No
List element Dropdown Tox_Code
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -16
12722008 Responses are in alphanumeric format as Categories
5117 Ingredient_CLP_MutagenGen
otox
Ingredient Classification with regards
mutagenicitygenotoxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5118 Ingredient_CLP_Carcinogenity Ingredient Classification with regards to its carcinogenity based on Regulation (EC) No
12722008 Responses are in alphanumeric
format as Categories
List element Dropdown Tox_Code
5119 Ingredient_CLP_Reproductive_Tox
Ingredient Classification with regards to its reproductive toxicity based on Regulation (EC) No 12722008 Responses are in alphanumeric format as Categories
List element Dropdown Tox_Code
5120 Ingredient_CLP_STOT Ingredient Classification with regards to its specific target organ toxicity based on Regulation (EC) No 12722008 Responses are
selected from the dropdown list provided Responses are in numeric format as Categories
List element Dropdown Tox_Code
5121 Ingredient_CLP_STOT_Description
Reference to the specific organ(s) affected in text format based on the above classification
String Text
5122 Ingredient_CLP_Aspiration_Tox
Ingredient Classification with regards to aspiration toxicity based on Regulation (EC)
No 12722008 Responses are in numeric format as Categories
List element Dropdown Tox_Code
5130 Ingredient_Tox_Data Existence of toxicological data available for either as an individual substance or as part of a mixture and in heated or unheated form See Table 36 of the Reference Data section for
potential responses
List element Dropdown M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -17
5140 Ingredient_Tox_Emission Existence of studies that indicate the chemistry andor toxicity of emissions including but not limited to Experiments to indicate breakdown and
intact transfer of an ingredient to vapour or Studies to evaluate the proportion of an
ingredient that transfers intact into the emissions andor studies to identify any breakdown products
Studies on the effect of addition of an
ingredient to the test article on emission
composition and toxicity
Boolean Checkbox FM
5141 Ingredient_Tox_CMR Existence of any CMR related study including
but not limited to In vitro toxicological assays to evaluate
potential genotoxic and cytotoxic
properties Assays to determine the effect of the
ingredient on the reproductive system and its potential to cause birth defects
Assays to determine whether the
ingredient affects the tumorigenic properties of the product (The analyses
should be based on either inhalation or dermal exposure for the latter)
Boolean Checkbox FM
5142 Ingredient_Tox_CardioPulmonary
Existence of In vitro and in vivo assays to
evaluate the toxicological effects of the
ingredient on the heart blood vessels or
respiratory tract
Boolean Checkbox FM
5143 Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of the ingredient ie
whether the ingredient promotes dependence
Boolean Checkbox FM
5144 Ingredient_Tox_Other Existence of any other toxicological data not stated above
Boolean Checkbox FM
5150 Ingredient_ToxAddictive_File Files related to the relevant toxicological data above in items (5140-5144) referring in particular to their effects on the health of
File File browser FM
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -18
consumers and taking into account inter alia any addictive effects For each ticked checkbox above a pdf file upload will be available
25 Emissions
Item
Field Comments Data Type Control Type White list Reporting Visibility
615 Emission_Test_Product_EC-ID If the product requires an additional product(s) for use the EC-ID of the additional product(s) used to carry out the tests must be provided
Decimal Text M
625 Emission_Protocol_Type The type of protocol used for the production of
e-cigarette emissions In the absence of
agreed standardsprotocols emissions
measuring should be performed for both the
recommended medium range wattage and the
recommended under normal use maximum
wattage
After a unified standardprotocol for emission
measuring has been approved by the EC the
stakeholders will have to repeat the tests using
the standardised protocol and to submit this
information to the competent authorities
List element Dropdown M
631 Emission_Methods_File Pdf file on the production and measurement
methods used to assess the emissions The
file should contain substantial information for
the regulator to understand and duplicate if
necessary the emission test and also include
where the emission testing took place
File File browser M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -19
640 Emission_Name Name of the emissions produced during the
testing of the product selected from a
dropdown list in Reference Table 37
List Element Dropdown M
643 Emission_Quantity The quantity of the emission produced during
the process of using the product
Numeric Text M
644 Emission_Units Unit in which the emission is measured List Element Dropdown M
26 E-cigarette specific
Item
Field Comments Data
Type
Control
Type
Reporting
for e-
cigarettes
Reporting
for e-
cigarette
refill
container
Visibility
1110 E-Cigarette_Description Description of the e-cigarette or refill container to
facilitate unique product identification including a
description of the individual parts (componentse-
liquid)
String Text M M
1115 E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank
size for cartridgescartomisers or for refill container
actual volume when placed on the market)
Decimal Text M M
1116 E-
cigarette_Nicotine_Concentrat
ion
The nicotine concentration of the liquid in the e-
cigarette or refill container in mgml
Decimal Text M M
1120 E-Cigarette_Battery_Type Description of the type of battery used including its
chemical composition (type)
String Text M NA
1121 E-
Cigarette_Battery_Type_Capa
city
Indication of the battery capacity in mAh Decimal Text M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -20
1122 E-
Cigarette_VoltWatt_Adjustab
le
Verification that the e-cigarette is either
voltagewattage adjustable Responses are as noted
in Table 37 of the Reference Section data
List
element
Dropdown M NA
1130 E-Cigarette_Voltage The stable voltage of the e-cigarette if response to
Item1121 is ldquo3rdquo or ldquo4rdquo
Decimal Text F NA
1131 E-
Cigarette_Voltage_Lower_Ran
ge
Lower voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1132 E-
Cigarette_Voltage_Upper_Ran
ge
Upper voltage obtainable if response to Item1121
is ldquo1rdquo or ldquo2rdquo
Decimal Text F NA
1140 E-Cigarette_Wattage Steady wattage output if it is not adjustable if
response to Item1121 is ldquo2rdquo or ldquo4rdquo
Decimal Text F NA
1141 E-
Cigarette_Wattage_Lower_Ra
nge
Lower wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1142 E-
Cigarette_Wattage_Upper_Ra
nge
Upper wattage obtainable if response to Item1121
is ldquo1rdquo or ldquo3rdquo
Decimal Text F NA
1150 E-
Cigarette_Airflow_Adjustable
Indication if the airflow of the e-cigarette is
adjustable
Boolean Checkbox M NA
1160 E-Cigarette_Wick_Changeable Indication that the consumer may
adjustalterreplace the wick
Boolean Checkbox M O
1170 E-Cigarette_Microprocessor Indication of the existence of a microprocessor in the
e-cigarette
Boolean Checkbox M NA
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -21
1180 E-Cigarette_Coil_Composition Chemical composition of the wiring (coil) in the
atomiser
String Text M O
1190 E-
Cigarette_Nicotine_DoseUpta
ke_File
Pdf document for the nicotine dosinguptake studies
This file must include
1) Evidence from internal or published studies with
regards to nicotine dosing and uptake that the
manufacturerimporter is aware of
2) Total nicotine delivery per device or refill
container that is provided in the vapour assuming a
100 uptake by the consumer
File File
Browser
M M
11100 E_Cigarette
_Child_Tamper_Proof
Declaration that the product is child resistant and
tamper proof is protected against breakage and
leakage and have a mechanism that ensures refilling
without leakage (where applicable)
Boolean Checkbox M M
11110 E-Cigarette_Production _File Pdf file with the description of the final production
process including series production
File File
Browser
M M
11120 E-
Cigarette_Production_Confor
mity
Declaration that the production process ensures
conformity (including but not limited to information
on series production)
Boolean Checkbox M M
11121 E-Cigarette_Quality_Safety A declaration that the manufacturer and importer
bear full responsibility for the quality and safety of
the product when used under normal or reasonably
foreseeable conditions
Boolean Checkbox M M
11122 E-cigarette_High_Purity Declaration that only ingredients of high purity are
used in the manufacture of the liquid This include at
the minimum the following
String Text M M
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -22
The diluents shall comply to the requirements of the European Pharmacopeia
Nicotine should comply to the requirements of the European Pharmacopeia
Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl propionyl in the liquid
11123 E-cigarette_Non_Risk Declaration that the product does not pose
reasonably foreseeable risk to human health under
normal conditions of use (with the exception for its
nicotine content)
Boolean Checkbox M M
11124 E-
cigarette_Consistent_Dosing
Declaration of nicotine dosing at consistent levels
during product use and across batches under normal
or reasonably foreseeable conditions
String Text M M
11124 E-
cigarette_Consistent_Dosing_
Methods
Relevant PDF file describing how they ensure
consistent dosing in the absence of an agreed
standardprotocol
File File
Browser
11130 E_Cigarette_OpeningRefill
_File
Pdf file with the description of the opening and refill
mechanism where applicable
File File
Browser
M for
refillable e-
cigarettes
M
11150 E_Cigarette_Leaflet_File Pdf file for the uploading of the scanned file of the
leaflet of information for consumers that will include
Instructions for use and storage of the product
including a reference that the product is not
recommended for use by young people and non-
smokers contra-indications warnings for specific
risk groups possible adverse effects addictiveness
and toxicity and contact details of the manufacturer
or importer and a legal or natural contact person
within the Union
File File
Browser
O O
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -23
3 Reference Data
31 Type of submission
32 Product Type
Value Name
10 Electronic cigarette ndash Disposables including disposable kits
11 Electronic cigarette ndash Rechargeable non-refillable including assembly kits
12 Electronic cigarette ndash Rechargeable refillable including assembly kits
13 Electronic cigarette - Refill container containing e-liquid
14 Other components of electronic cigarettes intended to contain e-liquid
33 Marketing Data Available
Value Name
1 No marketing data available
2 Marketing data is available but not new
3 New marketing data has been obtained since the last reporting period
Value Name
1 New product submission including a submission of a product modification in recipe or design (New EC-ID number)
2 Submission of new informationdata on an existing product NOT leading to a modification in recipe or design (Update of EC-ID version)
3 Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of EC-ID version)
4 Cancellation of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -24
34 Ingredient Function
NOTE This list also includes functions for other regulated products
35 Ingredient Unburnt Status
Value Name
0 No available information on the ingredientrsquos toxicity in unburnt form
1 Not toxic and without CMR properties in unburnt form
2 Identified as toxic and or with CMR properties in unburnt form
Value Name
1 Addictive Enhancer
2 Adhesive
3 Binder
4 Carrier
5 Colour
6 Combustion Modifier
7 Casing
8 Fibre
9 Filler
10 Filter Component
11 Filtration Material
12 Flavour andorTaste Enhancer
13 Humectant
14 pH Modifier
15 Plasticiser
16 Preservative
17 Solvent - Processing Aid
18 Reduced Ignition Propensity Agent
19 Sizing Agent
20 Smoke Enhancer
21 Smoke Colour Modifier
22 Smoke Odour Modifier
23 Wrapper
24 Water-Wetting Agents
25 Viscosity Modifier
26 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -25
36 Toxicological Data Available
Value Name
1 No toxicological data available
2 Toxicological data is available but not new
3 New toxicological data has been obtained since the last reporting period
37 Emission Name
Name
1 Nicotine in vapour
2 Ethylene glycol
3 Diethylene glycol
4 Carbonyl Formaldehyde
5 Carbonyl Acetaldehyde
6 Carbonyl Acrolein
7 Carbonyl Crotonaldehyde
8 TSNA NNN
9 TSNA NNK
10 Trace metal Cadmium
11 Trace metal Chromium
12 Trace metal Copper
13 Trace metal Lead
14 Trace metal Nickel
15 Trace metal Arsenic
16 Trace metal Mercury
17 Trace metal Tin
18 Trace metal Silicon
19 VOC Toluene
20 VOC Benzene
21 VOC 13-Butadiene
22 VOC Isoprene
23 Flavour ingredients Diacetyl
24 Flavour ingredients Acetyl Propionyl
25 Other
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex B -26
38 E-Cigarette VoltageWattage Adjustable
Value Name
1 Yes voltage and wattage adjustable
2 Yes only voltage adjustable
3 Yes only wattage adjustable
4 No un-adjustable
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 1
Annex C Data Dictionary Technical Justification Document
1 Introduction
In this ANNEX we provide a description and scientific and regulatory justification of all terms
included in the data dictionary This is directly linked to the Data Dictionaries in Annex A
and Annex B and is complimentary to these documents This working document provides
the insight into the EUREST train of thought and its processes and is not based on a
separate review of the literature
We separate the variables initially based on those that are requested for all products
and secondly for those requests that are product specific (ie specific to e-cigarettes
smokeless tobacco cigars or cigarettes etc)
System generated variables are not discussed as they are internal to the system and
not modifiable but allow for the linkage of domains
The variables included here are based on the understanding that an offline process
will initiate the submission of the data and the registration of the submitter After
registration the submitter would be provided with appropriate log-in access
The document should be read with the data dictionary open so as to facilitate its
reading
All responses that the submitter will provide are to be in numeric format unless
explicitly stated otherwise in the data dictionary This is done so as to receive data
that can be merged into one common dataset (string columns canrsquot be merged) and
to avoid language issues and spelling mistakes The importance of such a merge
dataset of all information submitted within or across EU MS canrsquot be stressed enough
as it is this activity that will allow for the monitoring of product changes and product
evolution across the EU
String responses with multiple variables have each variable separated with a
semicolon ldquordquo so as to allow for data separation at the dataset analysis stage The
breakdown of such string variables into numeric responses would at this stage make
the reporting format extremely complicated In a future revision such string
variables should be transformed into categorical variables that would allow for the
data to be merged
Variable description
Application User Characteristics
The data that was requested here through this table is now collected through an offline
procedure Once the submitter (or a third person authorized to act on behalf of the
submitter) has been authorized and approved then heshe will be provided with the
necessary information to log on to the reporting system and upload the necessary
information
2a Fields related to submitter characteristics
Submitter_ID Submitter_Name Submitter_SME Submitter_VAT Submitter_Type
Submitter_Address Submitter_Country Submitter_Phone Submitter_Email
Submitter_Has_Parent_Company Submitter_Has_Subsidiary_Company
Submitter_Appoints_enterer In these fields the submitter characteristics and contact
information must be submitted It is likely that some of this information must also be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 2
requested during the offline registration procedure of the submitter The submitter is either
the manufacturer or importer responsible for the submitted data As defined in TPD 23(1)
the obligation to provide the requested information shall lie primarily with the manufacturer
if the manufacturer is established in the Union The obligation to provide the requested
information shall lie primarily with the importer if the manufacturer is established outside
the Union and the importer is established inside the Union The obligation to provide the
requested information shall lie jointly with the manufacturer and the importer if both are
established outside the EU
2b ManufacturerImporter Parent company characteristics
This information is requested once the Item 290 (ldquoSubmitter_Has_Parent_Companyrdquo) is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Parent_IDrdquo
ldquoSubmitter_Parent_Namerdquo ldquoSubmitter_Parent_Addressrdquo ldquoSubmitter_Parent_Countryrdquo
ldquoSubmitter_Parent_Phonerdquo ldquoSubmitter_Parent_Emailrdquo
2c ManufacturerImporter subsidiary company characteristics
This information is requested once the Item 2100
(ldquoSubmitter_Has_Subsidiary_Companyrdquo) is checked as ldquoYesrdquo This would open the following
data variables ldquoSubmitter_Subsidiary_IDrdquo ldquoSubmitter_Subsidiary_Namerdquo
ldquoSubmitter_Subsidiary_Addressrdquo ldquoSubmitter_Subsidiary_Countryrdquo
ldquoSubmitter_Subsidiary_Phonerdquo ldquoSubmitter_Subsidiary_Emailrdquo
2d Enterer reports on behalf of the submitter
This information is requested once the Item 2110 ldquoSubmitter_Appoints_entererrdquordquo is
checked as ldquoYesrdquo This would open the following data variables ldquoSubmitter_Principal_IDrdquo
ldquoSubmitter_Principal_Namerdquo ldquoSubmitter_Principal_Addressrdquo
ldquoSubmitter_Principal_Countryrdquo ldquoSubmitter_Principal_Phonerdquo ldquoSubmitter_Principal_Emailrdquo
3a Product Submission and Description ndash Part A
Submission_Type This variable requests from the submitter the type of submission that
they wish to perform Users will have the ability to perform a submission of a new product
to update data on an existing product to correct data on an existing product leading to a
modification addition at the level of product presentation or to perform a submission
cancellation as outlined in Reference Table 31 of the Data Dictionaries This is to notify the
system of the type of data that will be submitted so that the system domains are linked
appropriately It is mainly a functional parameter mandatory for all products and based on
TPD 5(1) and 20(2)
New product submission including a submission of a product modification in declared
recipe or design (New Product-ID number)
Submission of new informationdata on an existing product NOT leading to a
modification in recipe or design (Update of Product-ID version)
Submission of new informationdata on an existing product leading to a
modificationaddition at the level of product presentation (Update of Product-ID
version)
Submission_Start_Date Submission_End_Date The variable ldquoSubmission_Start_Daterdquo
which is to be calculated by the system when the user submits the product (Date will have
the following format ddmmyyyy Ex 29022015) ldquoSubmission_End_Daterdquo represents
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 3
the date between two versions of the same product as generated by the system whenever
the user performs an action that would lead to a change of the product ID (TP or EC) version
Product_ID Product_ID_Other_Exist Product_ID_Other Specifically the unique ID is
given to each product This is the common key between different submission versions of the
same product It is proposed to be in the format of ldquoSubmitter ID number- year in 2 digits-
product numberrdquo (NNNNN-NN-NNNNN where N is a number) Two types of IDrsquos exist One
for tobacco products (named TP-ID) and one for e-cigarettes (named EC-ID) In the absence
of one common number or identification code throughout the globe for such products this
ID is suggested to be used as a ldquoKEYrdquo in the variable list
With ldquoProduct_ID_Other_Existrdquo the submitter is aware of another product with identical
design and recipe that is marketed in the EU using a different Product-ID The field of
ldquoProduct_ID_Otherrdquo is mandatory if the above field of ldquoProduct_ID_Other_Existrdquo is checked
Additional ldquoProduct_IDrdquo fields for when the same product (same recipe and design
characteristics) is marketed in another EU MS The submitter reports which other
Product_IDs exist for this identical product in other MS Each additional ID is separated with
semicolons () Updating this field does not interfere with the product number but it changes
the product version
Product_Type This is the key ldquorootrdquo variable of the data dictionary based on which each
specific product is reported In this field the submitter must state the product for which
heshe will be submitting data This list is based on the existing categories of the current
EU reporting format with the addition of product types noted by i) the articles of the TPD
ii) the MS feedback that indicated that certain groups are missing iii) Comparisons with the
Canadian and US format and iv) TIS suggestions The new fields added were ldquocigarillordquo
ldquoelectronic cigaretterdquo ldquoelectronic cigarettes refill containerrdquo ldquoherbal product for smokingrdquo
ldquonovel tobacco productrdquo These additions are needed to cover the gap between the existing
reporting format and the new TPD articles Based on the response provided to this item
specific columns of the common reporting format are then requested to be completed Based
on the submitter response to this question the appropriate reporting format variables are
then provided
Product_Length and Product_Diameter (for cigars cigarillos and cigarettes) These two
measurements which describe the average total length of the product unit and its average
diameter (measured at the point with maximal diameter) are expressed in mm These
variables help identify the actual product and aid in stratifying the reporting These two
factors are noted in the Brazilian reporting format but are not in the current EU reporting
format The inclusion of these two parameters allows for a) unique product identification
and potential stratification of products by their length (regular king long ultra-long) or
their diameter (slim vs non slim)
Product_Weight and Product_Tobacco_Weight (only for tobacco products) The variable
ldquoProduct_Weightrdquo describes the weight of one unit of product including the specified
moisture which is expressed in mg This variable is requested for all products as part of a)
unique product identification and b) issues related to ingredient dosing A unit of product is
one cigar one cigarillo one cigarette one pouchbit etc of SLT One unit for all loose
products is 1 g including the moisture content and expressed in mg This weight includes
the moisture content and it is expressed in mg These two aspects were retained from the
current reporting format however are selectively applied based on the TPD requirements
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 4
Product_Weight_E-liquid amp Product_Volume_E-liquid They provide the total weight of e-
liquid in one product unit in mg and the total volume of e-liquid in one product unit in ml
respectively
Product_Manufacturer_Identification If the submitter is not the manufacturer of the
product then here he she would state the official company name of the manufacturer of
the product and other information that would aid the identification of the manufacturer
Should multiple companies produce the same product this should be described
Product_Production_Multiple_Sites and Product_Production_Site_Address This section
defines if the product in the current presentation is produced in multiple sites and the
complete address of the sites where product production is completed The Item
ldquoProduct_Production_Site_Addressrdquo is repeated for each product production site
Product_Technical_File (for cigarettes and RYO) The variable ldquoProduct_Technical_Filerdquo is a
pdf file as the relative technical document setting out a general description of the additives
used and their properties
ldquoProduct_Filterrdquo and ldquoProduct_filter_lengthrdquo These fields refer to the technical and
manufacturing characteristics of the filter if one exists
Product_Market_Research_Available (only for electronic cigarette and refill containers) This
variable provides information about the existence of market data available and is requested
to select one of the options available in reference table 312 of the Data Dictionary
3b Product Submission and Description ndash Part B
Product_Brand_Name Product_Brand_Subtype_Name These are the brand name of the
product and the brand subtype name of the product as they are marketed in the MS for
which the data are submitted The variable of the product brand name was assessed to be
beneficial and was retained from the current reporting format
Product_Launch_Date This is the date that the submitter plans to launch the product on to
the market This differs from the ldquoSubmission_Start_Daterdquo and ldquoSubmission_End_Daterdquo
above as the submission start date must precede the date during which the product will
enter the market
ldquoProduct_Unit_Picture_Filerdquo and ldquoProduct_Package_Picture_Filerdquo The variable
ldquoProduct_Unit_Picture_Filerdquo indicates the relevant picture of individual unit in pdf form The
picture should be clear enough to view details and aid in unique product identification This
would allow for the collection of an ldquoactualrdquo example of the final marketed product This
information is not collected in the current reporting format however is routine practice in
both the Canadian and Brazilian reporting formats who actually request a sample to be sent
to the central regulators As this process would probably lead to an overflow of actual
products collected at either a national or EU level and would encompass certain purchase
and shipment costs we propose that if part of the reporting this information be provided
in the form of a picture file that would aid individual product identification by MS and EU
regulators Moreover the provision of a picture of the product package
ldquoProduct_Package_Picture_Filerdquo would allow for the collection of an ldquoactualrdquo example of the
final marketed product This information is not collected in the current reporting format
however is routine practice in both the Canadian and Brazilian reporting formats who
actually request a sample to be sent to the central regulators As this process would probably
lead to an overflow of products collected at either a national or EU level and would
encompass certain purchase and shipment costs we propose that if part of the reporting
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 5
this information be provided in the form of a picture file that would aid individual product
identification by MS and EU regulators
Product_Multiple_Presentation Based on the number of multiple presentations reported in
Item 360 ldquoProduct_Multiple_Presentationrdquo the following variables are requested for each
individual presentation For instance if a company reports that they have 5 types of
presentation for a product then the info below would be completed five times once for each
type of presentation This will allow the regulator to see if other presentations of the same
product are available EUREST proposes to increase the number of attributes that will be
collected with regards to product design characteristics as this would allow for the easier
identification-and comparison- of products between MS
Product_Internal_Number Product_Manufacturer_Number Product_UPC_Number
Product_EAN_Number Product_GTIN_Number Product_SKU_Number These fields are
used to be able to ensure the unique identification of the product These 4 parameters are
closely linked to each other to allow for the introduction of a product ID Based on the
research from the TIS and the ECIS no unique identification system is used throughout the
industry with each company using one or more of the above identification systems
Specifically for the ECIS the UPC (Universal Product Code) was noted as the most commonly
used however we cannot verify with certainty that this is the appropriate approach
Moreover other reporting formats (US-Canada) request the UPC the SKU (Stock Keeping
Unit) or the internal manufacturer number Hence the current working hypothesis is that a
combination of product identifiers will be needed to verify the individuality of the products
Specifically we will request the industry to report at least one of the above parameters ndashin
a consistent manner For each of the parameters above specific rules are identified to
ensure that the submission system will recognize only codes of valid format for each of the
reporting types
Product_National_Market The member state for which the product information below is
being provided The EU MS is selected from a dropdown list
Product_Package_Type (only for tobacco products) Products_Package_Units These fields
refer to the monitoring of the external packaging of the product and identification of the
product unit The collection of this information will aid in unique product identification and
issue which has not been addressed and canrsquot be addressed comprehensively under the
current status quo Within the field ldquoProduct_Package_Typerdquo the manufacturerimporter is
requested to select one of the options available in Reference Table 33 of the Data
Dictionary This information is requested in the Canadian and Brazilian reporting formats
Product_Package_Net_Weight (only for tobacco products) The variable
ldquoProduct_Package_Net_Weightrdquo describes the weight of the product contained within one
package which is expressed in g (without packaging)
Product_CLP_Classification (only for electronic cigarettes and refill containers) This variable
defines the overall product classification as a mixture of substances based on Regulation
(EC) No 12722008 and as described in the ldquoGuidance on the Application of the CLP Criteriardquo
This takes into account collectively the potential toxicity at a ldquoproduct levelrdquo
Product_Maximum_Sales_Price Product_Sales_Volume These variables are included in the
current reporting format and are based through TPD 5(6) Firstly ldquoProduct_Sales_Volumerdquo
is explicitly requested in the TPD for cigarettes and RYO and will substantially aid regulators
assess market trends ldquoMember States shall also require manufacturers and importers to
report their sales volumes per brand and type reported in sticks or kilograms and per
Member State on a yearly basis starting from 1 January 2015rdquo Sales volume will be reported
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 6
in sticks (cigarettes cigars cigarillos) or kilograms (oral fine cut) Submission of such
information in a predefined electronic format could be optionally requested by Member
States on the basis of Article 20 of the TPD for e-cigarettes ldquoMember States shall require
manufacturers and importers of electronic cigarettes and refill containers to submit
annually to the competent authorities (i) comprehensive data on sales volumes by brand
name and type of the productrdquo The ldquoProduct_Maximum_Sales_Pricerdquo is a variable that is
not trade secrets or unknown and are often adhoc requested by the MS regulatory office for
tobacco These aspects were also noted by MS as aspects of interest to collect More
importantly however the variable of ldquoProduct_Maximum_Sales_Pricerdquo may aid product
identification Based on TPD 5(6)
Product_Other_Market_Data Other market data that may be available to the submitter
Product_Market_Research_File This variable was not requested in the current EU reporting
format however is now clearly stated in the TPD 5(6) ldquoMember States shall require
manufacturers and importers to submit internal and external studies available to them on
market research and preferences of various consumer groups including young people and
current smokers relating to ingredients and emissions as well as executive summaries of
any market surveys they carry out when launching new productsrdquo While in WP1 MS
reported that this information would be useful the TIS again noted that this would be a
trade secret and hence not available to the general public Evaluating a few examples
provided by Stakeholders and based on internal document reviews and the examples
applied in the Canadian format we suggest that this information is not broken down into
individual variables (ie date sample size methodology etc) but collected in the form of
a common pdf file
4 Product Submission of annual data ndash Part C (Only for e-cigarettes)
If the submitter would like also to submit their annual information via the current submission
system they are to check a box which will activate the following reporting requirements
ldquoProduct_Annual_Reporting_Sectionrdquo ldquoProduct_Sales_Volumesrdquo
ldquoProduct_Mode_Of_Salesldquo ldquoProduct_Other_Market_Datardquo
ldquoProduct_Market_Research_Availablerdquo and ldquoProduct_Market_Research_Filerdquo Based on TPD
20(7) ldquoMember States shall require manufacturers and importers of electronic cigarettes
and refill containers to submit annually to the competent authorities comprehensive data
on sales volumes by brand name and type of the product information on the preferences
of various consumer groups including young people non-smokers and the main types of
current users the mode of sale of the products and executive summaries of any market
surveys carried out in respect of the above including an English translation thereofrdquo
5 Tobacco ingredient description
As defined in TPD 2(18) ldquoingredient means tobacco an additive as well as any substance
or element present in a finished tobacco product or related products including paper filter
ink capsules and adhesivesrdquo This table is completed for each specific type of ldquotobacco
ingredientrdquo used in the product similar to how other ingredients are reported
Tobacco_Part_Type Tobacco_Part_Type_Other ldquoTobacco_Part_Typerdquo is the type of
tobacco part as noted in TPD Article 2(1) Four different choices are provided We provide
some definitions to aid its understanding Tobacco leaf (ie whole leaf or parts) that has
been prepared solely by mechanical processing that involves no chemical additive or
substance other than potable water Tobacco Cut Stem refers to the inclusion of tobacco
stems in the product Reconstituted tobacco refers to a mixture created by reclaiming
remnants of virgin tobacco remaining after manufacture-elements that would otherwise be
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 7
wasted-that are combined into a malleable sheet Expanded tobacco is tobacco that has
been manufactured to increase its tobacco filling capacity An ldquootherrdquo option is provided for
tobacco ingredients that do not fall under this category for which a string variable is
provided ldquoTobacco_Part_Type_Otherrdquo
Tobacco_Part_Description_File This variable includes a pdf file which includes the overall
description of the manufactured part type in the recipe The description provides detailed
information on the quantitative and qualitative consistency of the manufactured tobacco
This also includes a brief description of the process used (ie paper vs cast slurry) if any
ingredients react together during processing and if so under what conditions Moreover any
other chemical measures (ie pH stabilisers ammonia phosphates etc) that are added are
also to be described This is complimentary to the detailed information provided through
Items 410 (Tobacco_Part_Type) 420 (Tobacco_Leaf_Type) 430
(Tobacco_Leaf_Cure_Method) and 440 (Tobacco_Quantity) for the tobacco leaf types
included in the reconstituted or expanded tobacco One pdf file should be uploaded for each
time a type in Item 410 is noted other than Response 1 tobacco leaf For manufactured
tobacco types used in a quantity below a certain percentage of the total tobacco content
one summary file may be submitted for these types as long as the total percentage of these
unreported manufactured tobacco types does not exceed a ceiling amount of the total
tobacco content The level for both these percentages still needs to be defined before
implementation in practice Based on TPD 5(1a) ldquoMember States shall require
manufacturers and importers of tobacco products to submit to their competent authorities
the following information by brand name and type (a) a list of all ingredients and quantities
thereof used in the manufacture of the tobacco products in descending order of the weight
of each ingredient included in the tobacco productsrdquo in conjunction with TPD 2(18)
ldquolsquoingredientrsquo means tobacco an additive as well as any substance or element present in a
finished tobacco product or related products including paper filter ink capsules and
adhesivesrdquo
Tobacco_Part_Manufactured_Source This variable refers to the manufacturersource of the
manufactured (reconstituted or expanded) tobacco Reconstituted tobacco from multiple
sources must be reported separately one by one Based on TPD 5(1a)
Tobacco_Leaf_Type Tobacco_Leaf_Type_Other The type of tobacco leaf used as defined
in Reference 36 of the data dictionary which provides a complete list of tobacco leaf types
A number of commonly used leaf types were noted as based on the Canadian reporting
format Specifically Virginia Burley Oriental Maryland Kentucky ldquoOtherrdquo and unspecified
(EUREST suggests if that it is less than 30 identifiable to one leaf type) are mentioned
For the variable ldquoTobacco_Leaf_Typerdquo responses are numeric while for the
ldquoTobacco_Leaf_Type_Otherrdquo variable the manufacturerimporter has the ability to note the
other rarer types that may be used in production This is a string variable Based on TPD
5(1a)
Tobacco_Leaf_Cure_Method Tobacco_Leaf_Cure_Method_Other These variables refer to
the cure method used for the leaf specific numeric responses are provided in Reference
table 37 (Air fire steam sun flue other) These are obtained from the literature and the
other international reporting formats As noted also in the US reporting format the cure
method is justified by the fact that it is needed to identify tobacco derived materials as these
factors change the tobacco composition by altering endogenous constituents (eg Sugars)
and in some circumstances add exogenous constituents (eg partially pyrolised organic
matter) For the variable ldquoTobacco_Leaf_Cure_Methodrdquo responses are numeric while for
the ldquoTobacco_Leaf_Cure_Method_Otherrdquo variable the submitter has the ability to note the
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 8
other name description of the cure method This is a string variable and is based on TPD
Art5 1(a)
Tobacco_Quantity The quantity of each of the tobacco parts noted specifically through the
combination of variables in Items 410 (Tobacco_Part_Type) - 420 (Tobacco_Leaf_Type)
- 430 (Tobacco_Leaf_Cure_Method) These quantities are reported in descending order of
weight in mg as the variable ldquoIngredient_Quantityrdquo is handled in the current reporting
format Tobacco related ingredients would be listed for each tobacco part type (and leaf
typecure method when referring top tobacco leaf where applicable) with each new tobacco
related ingredient would be a new ldquorowrdquo in the proposed EUREST reporting format Each
separate combination would have a different quantity in a different ldquorowrdquo similar to how non
tobacco ingredients are reported by ingredient category (Item 510) This is a key aspect
of the reporting as EUREST suggests that based on a cu-off of the tobacco quantity that
tobacco part ingredients should be provided to the general public as general tobacco
ingredients are handled (using a cut-off to separate confidential from public information)
This variable is based on TPD Art5 1(a)
6 Description of ingredients contained in the product
As defined in TPD Art2 p18 ldquoingredient means tobacco an additive as well as any
substance or element present in a finished tobacco product or related products including
paper filter ink capsules and adhesivesrdquo
Ingredient_Category Ingredient_Category_Other (for tobacco products only) The variable
ldquoIngredient_Categoryrdquo provides information on the whereabouts of the ingredient in the
actual product or in its emissions The current EU reporting format prerequisites were
updated with suggestions brought forward my MS and TIS which requested some changes
with regards to the inclusion of categories related to e-cigarettes cigars and cigarillos (such
as e-cigarette liquid (unburnt) and e-cigarette vapor (emission) The current list was also
compared with the list of the US reporting format to assess the ability to identify common
classifications between the reporting of the EU and the US New categories were added
based on the MS Industry and expert evaluation of the existing categories The complete
list of potential ingredient categories is in table 38 of the Reference Data section An ldquootherrdquo
option is provided for ingredients that do not fall to this category (Item 510) for which a
string variable is provided Based on TPD 5(1a) and TPD 20(2)
Ingredient_Name Ingredient_CAS Ingredient_CAS_Additional
Ingredient_FEMA_Number Ingredient_Additive_Number Ingredient_FL_Number
Ingredient_EC_Number The combination of these ingredient identifiers allow for unique
ingredient identification Initially we would like to describe how we concluded that these
variables should be requested and subsequently we explain how these variables are
practically reported These fields are used to identify the individual ingredients within a
product and allow for comparisons of ingredients between products The current system
allows for the reporting of either an ingredient name for submission or a CAS FEMA
Additive FL or EC number As noticeable the CoE number was removed from the list of
potential ingredient numbers used in the due to its limited usage and transition to the FL
number The variable ldquoIngredient_Namerdquo provides the submitter the ability to write the
chemical name of the ingredient (which would help ingredient classification in case of
multiple CAS numbers) The FEMA variable is deemed as the second most important
ingredient identifier after CAS as TIS feedback noted that this format covers the inclusion
of semi processed natural ingredients that do not have a CAS number (ie coffee bean
extract) We conclude that due to that the CoE number being replaced by the FL number
(which is used primarily and specifically for flavouring substances) and the similarity with
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 9
the FEMA number (that only evaluates substances for GRAS that are used to formulate
flavors to be added to human foods and not for flavor ingredients for use in tobacco
products e-cigarettes or other products that involve routes of exposure other than
ingestion) the most appropriate registration number used for identification of substances
in tobacco and cigarette products is the CAS number This is based on the feedback from
the MS the TIS and the ECIS that noted that the majority (in some cases 100) of
ingredients have a CAS number which all parties (and EUREST experts) noted that would
cover almost completely ingredient identification This is also the identifier suggested in the
Canadian and US format and was also noted in the current reporting format
Important facts about the CAS number
i A common misperception is that CAS numbers are unique EUREST would like to
stress that they are not CAS Registry Numbers may not be unique to chemical
structures or MDL numbers
ii It consists of 89 million organic and inorganic substances and 65 million sequences
a number far greater than other proposed registration numbers and with a
continuous daily update of approximately 15000 new substances
iii A CAS Registry Number includes up to 10 digits which are separated into 3 groups
by hyphens The first part of the number starting from the left has 2 to 7 digits
the second part has 2 digits The final part consists of a single check digit CAS
Numbers hence use the format xxxxxxx-yy-z
iv Moreover the use of CAS Registry Numbers is sometimes imprecise For example
suppliers may use the CAS Registry Number for a parent compound to describe a
modified substance (eg salt or hydrate) Although imprecise the use of an
unmodified parent compounds CAS Registry Number is not erroneous when
describing the modified compound This basis is applied in the EUREST reporting
format
Practically the submitter must notify the system if the ingredient has one multiple or no
CAS number based on the response to the ldquoIngredient_CASrdquo variable Should they reply
that the CAS number does not exist and then it is mandatory for them to submit at least
one of the other four options (FEMA Additive Number FL EC) In the case of multiple CAS
numbers the unmodified parent CAS number is to be used while the secondary CAS
numbers are to be provided in the field ldquoIngredient_CAS_Additionalrdquo Within this field the
secondary CAS numbers are to be written in string format separated by a semicolumn ()
between CAS numbers This method will allow the assessment of the secondary CAS
numbers at the stage of data analysis These variables are based on TPD 5(1a)
Ingredient_Quantity_Fluctuate (only for tobacco products) This variable declares that the
ingredient quantity does fluctuate A response of YES would make the subsequent items
(550 551 552 553) mandatory as detailed below
Ingredient_Recipe_Quantity This variable requests the weight of the ingredient included in
one unit of product in mg according to recipe Ingredients should be listed for each category
mentioned in Item 510 ldquoIngredient categoryrdquo above preferably in descending order of
weight Practically this means a new entry for each ingredient reported separately for each
category This same method will be applied for all products within the proposed common
reporting format including e-cigarettes
Ingredient_Recipe_Min_Level Ingredient_Recipe_Max_Level (only for tobacco products)
These two variables provide the min and the max levels of an ingredient according to recipe
When the declared quantity of the additive fluctuates the manufacturer should declare
lowest and upper range in weight (mg) of the specific ingredient in one unit of the product
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 10
The actual weight used for production of individual standardized batches should be always
within the reported range
Ingredient_Measured_Mean_Quantity (only for tobacco products) This variable provides
the measured mean (average) weight of the ingredient in mg that was added to one unit of
the product during the previous reporting period This ldquomeasured mean quantity is to be
calculated based on the average of the quantity of that ingredient added within each
standardized batch
Ingredient_Measured_SD (only for tobacco products) This refers to the statistically derived
standard deviation of the mean quantity of ingredient added to one unit of the product
within each standardized batch during the previous reporting period
Ingredient_Measured_Min_Level Ingredient_Measured_Max_Level (only for tobacco
products) These two variables provide the measured (actual) lower and upper values of
the weight quantity of that ingredient added to one unit of the product within each
standardized batch during the previous reporting period These correspond with the minimal
and maximal values recorded
Ingredient_Function Ingredient_Function_Other The variable ldquoIngredient_Functionrdquo
defines the function of the ingredient The ingredient functions are given in Table 39 of the
Reference Data section with their code and definition If an ingredient has multiple functions
all the function codes should be stated and are to be separated by semicolons () An ldquootherrdquo
option is provided as a response to Item 560 that does not fall under this category for
which a string variable ldquoIngredient_Function_Otherrdquo is provided
Ingredient_Priority_Additive (only for tobacco products) Notification if the ingredient is a
priority additive (Responses include Yes no not published yet) This is based on TPD
Art6 p2 Until the ldquoPriority additive listrdquo of the TPD is provided in May 2016 all responses
will be ldquonot published yetrdquo The rationale behind this classification is to request from the
submitter to flag the ingredients that will be in the priority list as for them they will have to
provide (when implemented) comprehensive studies that would examine their toxicity
flavor nicotine inhalation CMR properties etc as defined in TPD Article 6 p2
Ingredient_Priority_Additive_Files (only for tobacco products) This variable provides pdf
files of the report which shall include an executive summary and a comprehensive overview
compiling the available scientific literature on that additive and summarising internal data
on the effects of the additive Mandatory if response to 570 is ldquoYesrdquo Based on and Art6
p4
Ingredient_Unburnt_Status The variable ldquoIngredient_Unburnt_Statusrdquo provides evidence
on the toxicity of the ingredient or this ingredient has CMR properties This variablewas
retained as is from the current format however its responses were altered from string
format to numeric responses which would allow for easier database handling Responses
include
No available information on the ingredientrsquos toxicity in unburnt form
Not toxic and without CMR properties in unburnt form
Identified as toxic and or with CMR properties in unburnt form
Ingredient_REACH_Registration This variable refers to the registration under Regulation
(EC) No 12722008 respectively as presented in Article 5 of the TPD The variable
ldquoIngredient_REACH_Registrationrdquo is requested in numeric responses with each registration
separated CLP classification is also to be further assessed
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
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Annex C - 11
The REACH registration is comprehensive and would report the ingredientrsquos toxicological
information The complete list of responses is available in the document ldquoGeneral
Classification and Labelling Requirements for Dangerous Substances and Preparationsrdquo
Available at httpeceuropaeuenvironmentarchivesdansubpdfsannex6_enpdf
Ingredient_CLP_Classification This variable defines if the ingredient has been CLP classified
(12722008) and is in the CampL Inventory (A yes vs no response)
Ingredient_CLP_Acute_Tox_Oral Ingredient_CLP_Acute_Tox_Dermal
Ingredient_CLP_Acute_Tox_Inhalation Ingredient_CLP_Skin_CorrosiveIrritant
Ingredient_CLP_Eye_DamageIrritation Ingredient_CLP_Respiratory_Sensitisation
Ingredient_CLP_Skin_Sensitisation Ingredient_CLP_MutagenGenotox
Ingredient_CLP_Carcinogenity Ingredient_CLP_Reproductive_Tox Ingredient_CLP_STOT
Ingredient_CLP_STOT_Description Ingredient_CLP_Aspiration_Tox All the above variables
provide information about the toxicity of the ingredients and if these ingredients have been
CLP classified based on Regulation (EC) No 1272 2008 with regards to acute oral toxicity
acute dermal toxicity acute inhalation toxicity a skin corrosive irritant eye damage
irritation respiratory sensitisation skin sensitization carcinogenity reproductive toxicity
specific target organ toxicity accordingly The responses are in alphanumeric format The
variable ldquoIngredient_CLP_STOT_Descriptionrdquo refers the specific organ(s) affected in text
format based on the above classification The secondary effects should be noted these are
also to be included but not classified The variable ldquoIngredient_CLP_Aspiration_Toxrdquo
provides the ingredient classification with regards to aspiration toxicity based on Regulation
(EC) No 1272 2008 The responses are in numeric format Variables on toxicological data
are based on TPD 5(2) and 20(2)
Ingredient_Tox_Data This variable describes the existence of toxicological data available
for either as an individual substance or as part of a mixture and in burnt or unburnt form
The complete list of potential responses is as follows
No toxicological data available
Toxicological data is available but not new
New toxicological data has been obtained since the last reporting period
Ingredient_Tox_Emission This variable refers to the existence of studies that indicate the
chemistry andor toxicity of emissions including but not limited to
Experiments to indicate pyrolytic breakdown and intact transfer of an ingredient to
smoke or
Studies to evaluate the proportion of an ingredient that transfers intact into the
emissions andor studies to identify any breakdown products
Studies on the effect of addition of an ingredient to the test article on emission
composition and toxicity
Ingredient_Tox_CMR The variable describes the existence of any CMR related study
including but not limited to
In vitro toxicological assays to evaluate potential genotoxic and cytotoxic properties
Assays to determine the effect of the ingredient on the reproductive system and its
potential to cause birth defects
Assays to determine whether the ingredient affects the tumorigenic properties of the
product (The analyses should be based on either inhalation or dermal exposure for
the latter)
Ingredient_Tox_CardioPulmonary This variable provides information about the existence of
in vitro and in vivo assays to evaluate the toxicological effects of the ingredient on the heart
blood vessels or respiratory tract
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 12
Ingredient_Tox_Addictive Existence of an analysis of the possible addictive properties of
the ingredient ie whether the ingredient promotes dependence
Ingredient_Tox_Other This variable provides the existence of any other toxicological data
not stated above
Ingredient_ToxAddictive_File This variable includes files related to the relevant
toxicological data above in items (5140-5144) referring in particular to their effects on
the health of consumers and taking into account inter alia any addictive effects as referred
to in TPD 5(3) ldquoThe list referred to in point (a) of paragraph 1 shall also be accompanied
by the relevant toxicological data regarding the ingredients in burnt or unburnt form as
appropriate referring in particular to their effects on the health of consumers and taking
into account inter alia any addictive effects Furthermore for cigarettes and roll-your-own
tobacco a technical document setting out a general description of the additives used and
their properties shall be submitted by the manufacturer or importer Other than for tar
nicotine and carbon monoxide and for emissions referred to in Article 4(4) manufacturers
and importers shall indicate the methods of measurement of emissions used Member States
may also require manufacturers or importers to carry out studies as may be prescribed by
the competent authorities in order to assess the effects of ingredients on health taking into
account inter alia their addictiveness and toxicityrdquo For each ticked checkbox above a pdf
file upload will be available
7 Emissions
Emission_Tar (only for cigarettes) This variable is mandatory for cigarettes and defines the
emission of Tar according to the ISO standard 4387 with the accuracy measurements
determined in accordance with ISO standard 8243 Defined in Articles Art3 p1 amp Art4 p1
of the TPD
Emission_Nicotine (only for cigarettes) This variable is mandatory for cigarettes and defines
the nicotine yield according to the ISO standard 10315 with the accuracy measurements
determined in accordance with ISO standard 8243 Based on Articles Art3 p1 amp Art4 p1 of
the TPD
Emission_CO (only for cigarettes) This variable is mandatory for cigarettes and defines
theCO yield according to the ISO standard 8454 with the accuracy measurements
determined in accordance with ISO standard 8243 This variable is defined in Articles Art3
p1 amp Art4 p1 of the TPD
Emission_TNCO_Lab (for cigarettes) This variable identifies the laboratories used to
measure each of the above TNCO emissions from the list of the laboratories used by
manufacturers and communicated to the commission and is based on Based on TPD 4(2)
In case of multiple entries they should be separated by semi-colons () This is a string
variable
Emission_Other_Available (for tobacco products) This variable notifies the existence or not
of information on other emissions and their levels
Emission_Methods_File This variable requests a pdf file on the production and
measurement methods used to assess the emissions The file should contain substantial
information for the regulator to understand and duplicate if necessary the emission test and
also include where the emission testing took place Based on Art20 2(b) for e-cigarettes
and Art4(4) and Art5 p1(c) and p3 for other tobacco products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 13
Emission_Name This variable defines the chemical name of the emissions produced during
the testing of the product and is defined in TPD Art4 p4 and Art5 p1(c) and p3
Emission_CAS Emission_IUPAC These variables allow emission identification The variable
ldquoEmission_CASrdquo provides the individual emissionrsquos Chemical Abstract Service (CAS) registry
number The variable ldquoEmission_IUPACrdquo provides the emissionrsquos IUPAC name in case of
absence of a CAS number Based on TPD Art4 p4 and Art5 p1(c) and p3 For e-cigarettes
this is based on Art 20
Emission_Quantity Emission_Units The variable ldquoEmission_Quantityrdquo requests the
quantity of the emission produced during the process of using the product and the variable
ldquoEmission_Unitsrdquo defines the units in which the emission is measured
Emission variables that are specific to e-cigarettes based on Art 20(2b) include
Emission_Test_Product_EC-ID This variable provides the EC -ID of the test product
selected in accordance with the below criteria
Electronic cigarettes placed on the market in one piece (eg disposables) or as an
assembly kit (device and e-liquid together eg electronic cigarettes sold together
with an exchangeable cartridge or with a refill container) should be tested ldquoas isas
a unitrdquo and this EC-ID be reported
Each e-liquid placed on the market as a separately purchasable item (eg refill
containers or cartridges that can be used for more than one device) should be tested
at least with one hardware device with which it is compatible (the EC-ID of which
should be reported in 615)
Each hardware device placed on the market as a separately purchasable item should
be tested at least with one e-liquid with which it is compatible (the EC-ID of which
is to be reported in 615)
If a manufacturerimporter has to test ldquoat least withrdquo one hardware device or e-
liquid the company should test with a compatible best-selling (in volume) hardware
device or e-liquid (preferably from their own company or from the EU market) If
the company does not have at its disposal precise sales information the company
should use the best estimation available and perform testing with that compatible
hardwareliquid
Emission_Protocol_Type (for electronic cigarettes and refill containers) This variable
defines the type of protocol used for the production of e-cigarette emissions It has been
noted that
In the absence of agreed standardsprotocols emissions measuring should be
performed for both the recommended medium range wattage and the recommended
under normal use maximum wattage All other settings (ie airflow puffing etc) are
to be described within the next item Item 631 (methods)
After the unified standardsprotocols for emission measuring have been developed
the stakeholders will have to repeat the tests using the standardised protocol and to
submit this information to the competent authorities Based on TPD 20(2)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 14
8 Cigarette specific
Cigarette characterising flavour This classifies the cigarette as having a characterizing
flavour This is a new parameter derived from the breakdown of the very generic ldquoProduct
descriptionrdquo column of the current reporting format
Cigarette_Filter_Ventilation Cigarette_Filter_Drop_Pressure_Closed
Cigarette_Filter_Drop_Pressure_Open These fields refer to the technical and manufacturing
characteristics of the cigarette filter Some of these aspects were included in the
ldquoProduct_Descriptionrdquo of the current reporting format while these parameters are currently
in the Brazilian and Canadian reporting formats also These parameters allow for the
evaluation of two aspects a) unique product identification (as aforementioned such
examples were provided in the ldquoProduct_Description_Fieldrdquo and b) technical aspects that
may impact smoking intensity smell and taste and hence are covered under Article 7(7) of
the TPD ldquoMember States shall prohibit the placing on the market of tobacco products
containing flavourings in any of their components such as filters papers packages capsules
or any technical features allowing modification of the smell or taste of the tobacco products
concerned or their smoke intensityrdquo The scientific literature has clearly indicated that filter
characteristics impact smell taste and smoking intensity hence the necessity to collect such
information Practically this also should be reported so as to assess issues of identifying
products that are manipulated or have a characterising flavour
9 Smokeless (Oral-nasal-chewing) specific
Based on the definition of Smokeless tobacco in the TPD the following three categories were
used Oral tobacco Chewing tobacco Tobacco for nasal use
Smokeless_pH Smokeless_Total_Moisture Smokeless_Nicotine_Content Smokeless
_Unionised_Nicotine_Content These variables present the basic chemical analyses of a
smokeless tobacco product and are based on what is requested in other international
formats (USA Canada) The scientific basis for the inclusion of these variables is the fact
that these chemical attributes are directly related and influence nicotine availability and
product texture
Smokeless_Analysis_Methods This variable provides a brief text description of the methods
used to measure the above variables including references to more detailed information on
the approach This is a string variable
10 Novel Tobacco Products
Novel_ RiskBenefit_File With this variable a pdf file is requested on the RiskBenefit
analysis of the product its expected effects on cessation of tobacco consumption its
expected effects on initiation of tobacco consumption and predicted consumer perception
Based on TPD 19 (1c)
Novel_Contain_Tobacco This variable identifies if the novel tobacco product contains
tobacco
11 RYO-Fine cut - Pipe tobacco specific
The following information is available only for products that have the ldquoProduct_Typerdquo (Item
320) to ldquoFinecutrdquo OR ldquoPipe Tobacco
FinecutPipe_Total_Nicotine_Content FinecutPipe_Unionised_Nicotine_Content These
attributes provide the total nicotine content of the loose product per unit and the unionized
nicotine content of the loose content
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 15
12 E-cigarette specific
E-Cigarette_Description This variable provides a string response for the submitter to
describe the e-cigarette or refill container so as to aid unique product identification A
description of the individual parts of the e-cigarette or refill liquid is also to be provided
E-Cigarette_Liquid_Volume Volumecapacity in ml (for devices indicate tank size for
cartridgescartomisers or for refill container actual volume when placed on the market) This
is based under the clause of unique product identification Based on TPD 20(3)
E-cigarette_Nicotine_Concentration The nicotine concentration of in the e-cigarette or The
nicotine concentration of the liquid in the e-cigarette or refill container in mgml Component
description as defined in TPD 20 (2b)
E-Cigarette_Battery_Type E-cigarette_Battery_Type_Capacityrdquo and E-
cigarette_Battery_VoltWatt_Adjustable These variables cover aspects of the battery
under the auspices of component description as defined in TPD Art20 p2(e) ldquoa description
of the components of the productrdquo As e-cigarettes are an evolving device we already have
seen product changes in the types of batteries used over the past few years and we envisage
that this will be an area of significant research and product trialerror as battery output is
directly related to the provision of nicotine (ie the user ldquokickrdquo during use) and all of its
emissions In the variable ldquoE-cigarette_Battery_Typerdquo mainly we are asking the chemical
composition of the battery and any other information that may help identify unique
batteries The variable ldquoE-cigarette_Battery_VoltWatt_Adjustablerdquo is a filter variable that
will verifies if the e-cigarette is either voltage wattage adjustable Responses are provided
in Table 313 of the Reference Section data ldquoE-cigarette_Battery_Type_Capacityrdquo provides
an indication of the battery capacity in mAh
E-cigarette_Voltage E-cigarette_Voltage_Lower_Range E-
cigarette_Voltage_Upper_Range E-cigarette_Wattage E-
cigarette_Wattage_Lower_Range E-cigarette_Wattage_Upper_Range The collection of
these parameters allows us to assess multiple aspects of the e-cigarette including a) unique
product identification-as mentioned in the Interim report there are thousands of
combinations of MOD type cigarettes with one of the most important aspects the battery
that powers the device B) As battery output is directly related to atomizer temperature ndash
which is in turn related to the production of harmful emissions such as Carbonyl compounds-
collecting as much information on battery type is important The ECIS noted that this
information is important both for emission creation and for unique product identification and
should be collected in the new reporting format Overall as responses can be provided in
number format the inclusion of these parameters will help regulators assess the role of
battery changes of MOD e-cigarettes and the association between battery output and
emissions Again these parameters are based on component description as defined in TPD
20 (2e)
E-cigarette_Airflow_Adjustable E-cigarette_Wick_Changeable as with the above battery
oriented parameters these two variables collect further information on modifiable e-
cigarettes Market research has indicated that some MODS also allow the ability to change
airflow while the parameter ldquoE-cigarette_Changeablerdquo verifies that the e-cigarette wick
(atomizer) can be altered by the consumer These are all under ldquocomponent descriptionsrdquo
as defined in TPD 20 (2e) and allow for unique product identification
E-cigarette_Microprocessor Certain newer versions including MODS but also disposables
use microprocessors (electronic circuitry) to regulate nicotine dosing- aspects which are
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 16
sometimes referred to in the market as ldquodigital cigarettesrdquo Hence this information should
also be collected based on TPD TPD 20 (2e) Moreover this variable allows for unique product
identification
E-Cigarette_Coil_Composition This variable provides the chemical composition of the wiring
(coil) in the atomiser
E-cigarette_Nicotine_DoseUptake_File This variable defines the nicotine dosing and
uptake related to e-cigarettes as described in Article 20 p2(d) and p3 of the TPD While
effort was made to assess if the actual methods for nicotine dosing could be noted in numeric
format this was not deemed scientifically justifiable as there is no scientific base for a
standardized methodology of assessing nicotine dosing provided with each puff as each e-
cigarette manufacturer and the plethora of published scientific evidence indicate multiple
puffing regimes and methods of assessing dosing a fact verified by the feedback from the
ECIS Hence in this case it is premature to identify one method that will be used across the
industry hence we conclude that a file should be uploaded by each industry With regards
to ldquoNicotine_Uptakerdquo information the same principal applies here to as there is no
standardized methodology in the published literature to assess nicotine uptake
(pharmokinetics) which also may be disproportionate relative to the reporting
requirements hence we conclude that a file should be uploaded in this instance In both
cases (dosing vs uptake) a detailed file must include
Evidence from internal or published studies with regards to nicotine dosing and
uptake that the manufacturerimporter is aware of
Total nicotine delivery per device or refill container that is provided in the vapour
assuming a 100 uptake by the consumer
E_Cigarette _Child_Tamper_Proof This variable is in the form of a checkbox for which the
submitter has to provide his declarations Checking this box means that they declare that
their products are child and tamper proof they have childproof caps as defined in TPD
Art20 p2(e) Declaration that the product is child resistant and tamper proof is protected
against breakage and leakage and have a mechanism that ensures refilling without leakage
(where applicable) Technical specifications for this are currently being worked on by the
industry and by standardization committees however the final specifications to be adopted
would be based on the implementing acts of the TPD
E-Cigarette_Production_File E-Cigarette_Production_Conformity These variables request
the description of the production process including whether it involves or not series
production and a declaration checkbox that it confirms to the requirements of Article 20 of
the TPD This is noted in TPD 20 (2f) This may also include information regarding adherence
to hygiene and ISO practices as noted by ECIS responses collected through WP1 as also
production country
E-cigarette_Quality_Safety This variable is a checkbox that the manufacturerimporter
must bear full responsibility for the quality and safety of the product based on TPD 20 (2)
with a specific reference to p2(g)ldquoa declaration that the manufacturer and importer bear full
responsibility for the quality and safety of the product when placed on the market and used
under normal or reasonably foreseeable conditionsrdquo
E-cigarette_High_Purity This variable declares that only ingredients of high purity are used
in the manufacture of the nicotine-containing liquid It is worth noting that nicotine should
be of pharmaceutical quality while the purity levels of the other ingredients are to be
provided This parameter is defined in TPD 20 (2g) This include at the minimum the
following
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 17
bull The diluents shall comply with the requirements of the European Pharmacopeia
bull Nicotine should comply with the requirements of the European Pharmacopeia
bull Absolute absence of TSNAs Ethylene glycol diethylene glycol diacetyl acetyl
propionyl in the liquid
E-cigarette_Non_Risk This variable declares that the product does not pose reasonably
foreseeable risk to human health under normal conditions of use(with the exception for its
nicotine content) as defined in TPD 20 (2g)
E-cigarette_Consistent_Dosing E-cigarette_Consistent_Dosing_Methods The variable ldquoE-
cigarette_Consistent_Dosingrdquo declares the nicotine dosing at consistent levels during
product use and across batches under normal or reasonably foreseeable conditions A
relevant PDF file describing how they ensure consistent dosing in the absence of an agreed
standardprotocol is required with the variable ldquoE-cigarette_Consistent_Dosing_Methodsrdquo
E_Cigarette_OpeningRefill _File With this variable a file is provided related to the
description of the opening and refill mechanism as defined in TPD 20 (2e) ldquoa description of
the components of the product including where applicable the opening and refill
mechanism of the electronic cigarette or refill containersrdquo As standards for these refill
mechanisms are being developed EUREST envisages that this will be an area of significant
product evolution in the near future
E_Cigarette_Leaflet_File With this variable the e-cigarette manufacturers or importers
must upload a file of the scanned file of the leaflet of information for consumers that will
include Instructions for use and storage of the product including a reference that the
product is not recommended for use by young people and non-smokers contra-indications
warnings for specific risk groups possible adverse effects addictiveness and toxicity and
contact details of the manufacturer or importer and a legal or natural contact person within
the Union This was preferred to the submission of multiple text boxes as this way the
regulator will have a copy of what is received by consumers Based on TPD 20(4)
13 Other tobacco products not specifically mentioned
These products are included in the proposed common reporting format with variables
included in the above tables based on their reporting requirements as outlined in the TPD ndash
hence no other specific wording terminology will be applied These include cigars cigarillos
water pipe tobacco amp herbal products
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 18
HOW TO OBTAIN EU PUBLICATIONS
Free publications
bull one copy
via EU Bookshop (httpbookshopeuropaeu)
bull more than one copy or postersmaps
from the European Unionrsquos representations (httpeceuropaeurepresent_enhtm)
from the delegations in non-EU countries
(httpeeaseuropaeudelegationsindex_enhtm)
by contacting the Europe Direct service (httpeuropaeueuropedirectindex_enhtm)
or calling 00 800 6 7 8 9 10 11 (freephone number from anywhere in the EU) () () The information given is free as are most calls (though some operators phone boxes or hotels may charge you)
Priced publications
bull via EU Bookshop (httpbookshopeuropaeu)
Priced subscriptions
bull via one of the sales agents of the Publications Office of the European Union
(httppublicationseuropaeuothersagentsindex_enhtm)
EUROPEAN COMMISSION
Directorate-General for Health and Food Safety
Health programme
Annex C - 19
EB-0
4-1
5-4
06-E
N-N
doi10281830286