The poison information database according to Art 45 of the CLP

regulation and how it will affect biocidal products

Maristella Rubbiani

National Center for Chemicals

ISS Roma

Italy

Content

• Situation before CLP Regulation entered into force

• Legal requirements under the CLP Regulation

• Legal procedure

• Links to biocide legislation

• Future improvement

Legal Situation before CLP

• Directive 1999/45/EC (DPD) - Article 17

– ‘MS shall appoint body or bodies responsible for receiving information on preparations considered dangerous on the basis of their health or physical effects

– Appointed bodies shall keep information confidential

Legal Situation before CLP (continued)‏

– Information may be used • For medical purposes, in particular in event of

emergency

– Art. 17 does not define which information should be notified

– Resulted in different provisions by MS, different: • Procedures

• Requirements on composition/concentrations

• Notification formats, tools

CLP Regulation - Article 45

• Provisions in Art. 45 of CLP similar to Art. 17 DPD

– MS shall appoint body or bodies responsible for receiving information on mixtures classified as hazardous on the basis of their health or physical effects

– Appointed bodies shall keep information confidential

CLP Regulation - Article 45 (continued)‏

– Information may be used

• For medical purposes, in particular in event of emergency

• Where requested by MS, for statistical analysis to improve risk management measures, if needed.

CLP Regulation - Article 45 (continued)‏

• Article 45 (4) (introduced during co-decision procedure)‏

– ‘By January 2012, the Commission shall carry out a review to assess the possibility of harmonising the information..., including establishing a format for the submission of information by importers and downstream users to appointed bodies.

CLP Regulation - Article 45 (continued)‏

– On the basis of this review, and following consultation with relevant stakeholders … the Commission may adopt a Regulation adding an Annex to this Regulation.’

– Those measures, designed to amend non-essential elements of this Regulation, by supplementing it, shall be adopted in accordance with the regulatory procedures with scrutiny referred to in Article 54(3).

CLP Regulation - Article 45 (continued)‏

• Duties resulting from Article 45(4)‏ • Assessment of possibility of harmonising information

• Assessment of possibilities to establish a (harmonised)

format for submission of information

• No specific reference to a database at EU level

• Consultation with stakeholders, especially EAPCCT

• Legal implementation, if appropriate

Legal framework

CLP/

Dangerous

Preparations

Dangerous

Substance

REACH

Deter-

gents

Aerosol

Cosmetics

Paint

Biocidal

products

Links to other EU legislation

• Regulation on Plant Protection Products (Regulation (EC) No 1107/2009)‏

• Biocidal Product Regulation (Regulation 528 /2013 and Directive 98/8/EC)‏

• Regulation on Cosmetic Products (Regulation (EC) No 1223/2009)‏

Links to other EU legislation (continued)‏

• Regulation on Cosmetic Products (Regulation (EC) No 1223/2009)‏

– Article 13

• work already well advanced e.g. – Regulation contains a list of information to be submitted to

the Commission

– information has to be submitted electronically

– responsible COM Service is developing the "Cosmetic Products Notification Portal"

CLP Regulation

• The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required .

• Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay.

• Where labelling changes are required the supplier shall ensure that the label is updated within 18 months.

• The supplier of a substance or a mixture within the scope of Regulation 528/2013 or 1207/2009shall update the label in accordance with those Regulations.

Article 50 of the Biocidal Products Regulation

• It obliges an authorisation holder to notify the CA or, ECHA,

in case of changing any information submitted in relation to the initial application for authorisation.

• This includes re-labelling of a product, for new scientific or technical information, or for a change in composition, or because of new regulatory requirements (1 June 2015:application CLP Regulation).

• The same provision obliges the CA or Commission, to

decide whether the product still fulfils the criteria for being authorised and, terms and conditions of the authorisation.

Member States may require:

• the provision of models or drafts of the packaging, labelling and leaflets;

• that biocidal products made available on the

market in their territories be labelled in their

official language or languages.

European Association of Poisons Centres and Clinical Toxicologists

processing of new product

information

Index of product names and identifiers

Retrieval of product information for risk assessment during consultation

retrieval of comparable

products

1st registration of products

annual reports

retrieval of case series for scientific

studies

Categorisation

System for Agents

Recording of cases linked to the

exposed products

Those differences are caused by different tasks assigned to PCs at Member State level, e.g. use of the information also for market surveillance, enforcement, professional diseases etc As a result, a considerable variety of notification systems, data formats and country-specific requirements regarding the requested information have been developed in Member States. This leads to unnecessary burdens for companies operating in several Member States as they often have to submit the same or similar information in different formats or different information for the same mixture. It also leads to an uneven situation between Member States with regard to the information available to medical personnel and the general public in cases of poisoning incidents.

Issues to be discussed

• Is it possible and appropriate to harmonise information?

if yes

• Which information should be harmonised?

• Should there be a common format? if yes

• Which format?

Harmonization possible :

• Centralised versus decentralised system for submitting information

• Chemical composition of mixtures • Designation of ingredients • Establishment of a data set version identifier (DVI)‏ • Type of information requested • Product categorisation system (PCS)‏ • Unique company identifier (UCI)‏ • Unique product identifier (UPI)‏

A possible centralized system • DG Health and Consumer Protection considered that there

are many advantages linked to a centralised system, including:

• -all information is available in standardised form;

• the information is available for all products Europe-wide even if a certain product is only placed on the market in one or a limited number of EU Member States.

• Consumers can nonetheless buy them when travelling and take them back to their

• Member State of residence, even if the particular product is not placed on the market there;

• Companies would only need one notification instead of 27 different notifications in a worst-case scenario.

Info to be submitted

• Information about the composition of mixtures;

• Information on the product category;

• Information on the size and type of packaging, and

• Information on whether the product is used by consumers and / or by industrial users.

• Is it necessary and feasible to submit to the PCs the exact composition for all types of mixtures, including non-hazardous ingredients?

• What are the legal constraints? • What are the expected benefits compared to notification of

concentration bands? • Is there a need for / are there benefits from a unique

company identifier (UCI) and /or a unique product identifier (UPI) and, if yes, what should they look like?

• Which different procedures are currently used in Member States to receive the requested information; and are Member States ready to harmonise these procedures?

• Would a more centralised system, like, for example, the one established under the Cosmetic Products Regulation, be a solution; and how should such a system bemanaged and financed?

Possible answers

• The information on the ingredients in a mixture can be notified in concentration ranges/bands. The width of such ranges/bands should be defined as a function of the hazards of the substances.

• Non-hazardous ingredients should be notified as well, if they are present above a certain threshold that still needs to be defined.

• The designation of ingredients in mixtures should, where possible, follow the hierarchy

as outlined in Article 18 of the CLP Regulation.

Possible options

• The information contained in the extended SDS in line with Annex II to the REACH Regulation is considered to be sufficient for PC notifications, if some additional information will be provided as well (e.g. composition details as described above,

including also non-hazardous ingredients), product category (as described below) and

size and type of the packaging (which can be linked to the UPI).

Unique Product Identification (UPI)‏

UPI would be a useful tool that would actually solve a number of problems identified by PCs or by industry itself, e.g.

• to identify unambiguously the product involved in an incident;

• to determine the composition of mixtures composed of mixtures when suppliers do not

• to disclose all information to downstream users.

• to comparison of exposure data of products in certain categories between European Poisons Centres

• to better combine exposure data of European Poisons Centres into one european annual report

It is therefore highly likely that the impact resulting from the application of the CLP also inevitably leads to an increase of the items mentioned in the national databases archives for poison centers

CLP impact on mixtures

Category of Danger Concentration limit for classification

Acute oral toxicity 1* 0.025%**

Acute oral toxicity 2* 0.25%

Acute oral toxicity 3* 5%

Acute oral toxicity 4* 25%

STOT 1 1%

STOT 2 10% (but needs SDS on request at 1%)

Skin corrosion 1 5% (becomes Cat 2 skin)

Skin corrosion 1 3% (becomes Cat 1 eye)

Skin corrosion 1 1% (no classification)

Skin irritation 2 10%

Skin or respiratory sensitiser

1% (but needs SDS on request at 0.1%)

CM Cat 1a, 1b 0.1%

R Cat 1a and 1b 0.3% (but needs SDS on request at 0.1%)

CM Cat 2 1% (but needs SDS on request at 0.1%)

R Cat 2 3% (but needs SDS on request at 0.1%)

Aquatic acute 1 0.1% ****

Aquatic chronic 1 0.1% ****

Aquatic chronic 2 1%

Aquatic chronic 3 10%

Aquatic chronic 4 1 %***

* Based on ATE point estimate in Table 3.1.2, ** Note that if below limit of concern of 0.1% for Cat 1, the legal text implies that substances can be ignored unless it is known to be of concern. Rather vague ! *** Consider on case-by-case, especially if potential vPvB or PBT. **** Note M factor

Note that the text of the CLP Regulation covers this in detail and this is a summary of limited endpoints.

-DPD : 20 % -DPD : 5 %

Conclusions • It is possible and appropriate to harmonise the information to be

submitted to PCs; • There is a the need to develop a European product categorisation system; • It is possible to use a common IT format to submit the information and to

use XML;

Further work needs to be done with regard to: • the level of detail for the information concerning the composition of

mixtures; • the need for a unique company identifier and/or a unique product

identifier; • the need for, and the possibility to establish, a European database for

submitting notifications to Pcs. • With the introduction of CLP to mixtures, the number of classified

preparations will increas • Notifications should be possible in all official languages of the country in

which a company is marketing its product and/or alternatively in English.

Conclusion (continued)

• Poisons Centres in EU Member States have to prepare themselves to handle a substantially increased quantity and quality of information on hazardous mixtures and cosmetic products.

• Besides a change in hazard classification and hazard communication elements for substances and mixtures, the notification of product information by companies will change.

• For hazardous mixtures the possibility to harmonise the notification in EU Member States is currently reviewed by the EC as laid down in article 45 (paragraph 4) of the CLP Regulation.

• REACH Regulation had improved the toxicological information present on the new SDS.

• The development of a central European database for notification of cosmetic products is already in an advanced stage and the Cosmetic Products Notification Portal (CPNP) is working.

• Details of the data exchange format for both hazardous mixtures and cosmetic products are still under discussion, and where possible, should be aligned.

At national level…………

“The information contained in the database is confidential and will be used only for health purposes in view of preventive or therapeutic measures to be adopted, particularly, in emergency”.

PURPOSES OF THE ITALIAN DATABASE

The system is operational 24 h/day and 7 days/week. Direct connection for consultation is granted only to the national Poison Centres certified by the Ministry of Health as suitable by fulfilling specific criteria concerning their structural and human resources, and being able to ensure the secrecy of the confidential data contained in the database. On a case by case basis, the ISS may give the information to other central or regional bodies for their institutional tasks (e.g. controls, prevention, accidents etc.). Currently, 9 Italian Poison Centres have been granted direct access to the database

WHO ARE THE USERS

• Name/Address, Tel./Fax., e-mail of Registrant (mandatory)‏

• Trade name of the products (mandatory)‏

• Intended uses (mandatory)‏

• Physical state (mandatory)‏

• Other physico-chemical properties (optional)‏

• Full quali-quantitative chemical composition (mandatory)‏

• C&L (optional)‏

• Packaging description (optional)‏

WHICH KIND OF INFORMATION IS REQUIRED

Each registrant is assigned a “company code” and each preparation is assigned a “product code”

New preparations: For the dangerous preparations marketed for the first time in Italy after the entry in force of the Decree, the registration must be produced within 30 days as from the date of introduction into the Italian market.

DEADLINES

Those responsible for marketing in Italy dangerous preparations according to DPD and detergents (classified or not as dangerous) must send to the ISS information on these preparations (mainly the full chemical composition).

ISS guarantees the industry, about the confidentiality of the information stored in the database.

Actors:

• Producers (even those who produce elsewhere in the EU and market in Italy directly without traders)‏

• Importers from third Countries (even those who import elsewhere in the EU and market in Italy directly without traders)‏

• Traders of preparations produced in the EU who change the label for the Italian market (e.g. including their name)‏

WHO MUST REGISTER

ISS – Centro Nazionale Sostanze Chimiche

www.preparatipericolosi.it Responsible: maristella.rubbiani@iss.it

In Italy

Thank you for your attention!