European Association of Poisons Centres and Clinical Toxicologists Notification of product information to Poisons Centres The road to harmonisation at the EU level Pieter Brekelmans National Poisons Information Centre National Institute for Public Health and the Environment The Netherlands Workshop on the Harmonisation of Information for Poisons Centres - CLP Article 45(4) CLP - Regulation on Classification, Labelling and Packaging of Substances and Mixtures Brussels 24 November 2010
Transcript
European Association of Poisons Centres and Clinical Toxicologists
Notification of product information to Poisons CentresThe road to harmonisation at the EU level
Pieter Brekelmans
National Poisons Information CentreNational Institute for Public Health and the Environment
The Netherlands
Workshop on the Harmonisation of Information for Poisons Centres - CLP Article 45(4)
CLP - Regulation on Classification, Labelling and Packaging of Substances and MixturesBrussels 24 November 2010
European Association of Poisons Centres and Clinical Toxicologists
Why are we here?
The appointed bodies shall have at their disposal all the information required
from the importers and downstream users responsible for marketing
to carry out the tasks for which they are responsible
(CLP Regulation (EC) No 1272/2008, article 45/3)
European Association of Poisons Centres and Clinical Toxicologists
Example: Dutch Poisons Centre
• 24/7 information/advice on acute poisonings (public / professionals) www.vergiftigingen.info
• 24/7 medical advise in large incidents
• Annual reports / ad hoc reports
• Trend watching, analysis
• Research (fundamental, patients/volunteers)
• Product notification
Tasks of Poisons Centres
030-274 8888
NL: only for professionals
Risk analysis of acute poisonings on a secure website
www.vergiftigingen.infoChemical incidents
Radiation incidents
Annual reportsAnti-rain sprays cause serious lung damage
Tea with ‘decoration’ aniscauses hallucinations
Strong Dutch Cannabis:soft drug or hard drug?
Since 2007
Dangerous preparations
European Association of Poisons Centres and Clinical Toxicologists
Example: Dutch Poisons Centre
• 24/7 information/advice on acute poisonings (public / professionals) www.vergiftigingen.info
• 24/7 medical advise in large incidents
• Annual reports / ad hoc reports
• Trend watching, analysis
• Research (fundamental, patients/volunteers)
• Product notification
Tasks of Poisons Centres
030-274 8888
European Association of Poisons Centres and Clinical Toxicologists
European Association of Poisons Centres and Clinical Toxicologists
Art. 12 . Bodies responsible for receiving information relating to health
Member States shall appoint the body or bodies responsible for receiving information, including chemical composition, relating to preparations placed on the market and considered dangerous on the basis of their health effects or on the basis of their physico-chemical effects.
Member States shall take the necessary steps to ensure that the appointed bodies provide all the requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used to meet any medical demand by formulating preventive and curative measures, in particular in case of emergency.
Member States shall ensure that the information is not used for other purposes.
Member States shall ensure that the appointed bodies have at their disposal all the information required from the manufacturers or persons responsible for marketing to carry out the tasks for which they are responsible.
Dangerous Preparations Directive
European Association of Poisons Centres and Clinical Toxicologists
Different requirements on composition
Different requirements on ingredient concentration
Different procedures
Different forms
Different electronic formats
CAUSE:
European Association of Poisons Centres and Clinical Toxicologists
Step 1 – Reach consensus on required product information
Step 2 – Establish common (electronic) format
Step 3 – Implementation in EU legislation
=> EAPCCT guideline (1989!) is still a good compromise
=> SDS format as basis, but with additional info
=> Implementation in CLP Regulation
REGULATION (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures (“EU-GHS”)
Report conclusions
Harmonisation of product notification in the EU
European Association of Poisons Centres and Clinical Toxicologists
EC No 1272/2008, article 45, paragraph 4
By 20 January 2012 the Commission shall carry out a review to assess the possibility of harmonising the information referred to in paragraph 1, including establishing a format for the submission of information by importers and downstream users to appointed bodies. On the basis of this review, and following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), the Commission may adopt a Regulation adding an Annex to this Regulation
CLP regulation
European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues
Dr Herbert Desel, chair (Göttingen, EAPCCT Board)
Dr Hugo Kupferschmidt (Zürich, EAPCCT past-President)
Poisons Information Centres representatives from:
Netherlands Italy Norway
Germany Ireland Sweden
Belgium Switzerland Denmark
France Spain Estonia
EAPCCT working groupEAPCCT working group
European Association of Poisons Centres and Clinical Toxicologists
European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues
Current activities:- Harmonisation of Product Notification: CLP 45(4) review by COM (Uta
Jensen)lead: Ronald de Groot (NL)
- Cosmetic Products Notification Portal (CPNP) working group (Aurelien Perez)lead: Herbert Desel (DE)Ad hoc WG on IT issues lead: Pieter Brekelmans (NL)Ad hoc WG on Categorisation lead: Andreas Stürer (DE)Ad hoc WG on Frame Formulations lead: Martine Mostin (BE)
EAPCCT working group
European Association of Poisons Centres and Clinical Toxicologists
European Association of Poisons Centres and Clinical Toxicologists
Lead by Dr. Uta Jensen-Korte- Sept 18th 2009 Introductory meeting - March 17th 2010 1st meeting of COM and PIC representatives- May 28th 2010 2nd meeting of COM, PIC and some GA
representatives
- June 17th 2010 Caracal meeting (EC)
- Aug 2010 3rd meeting with PIC representatives
- Sept 2010 endorsed draft of EAPCCT 2010 guidelines - Nov 24th 2010 Workshop with all stakeholder representatives
CLP 45(4) review
By DG Enterprise & Industry
European Association of Poisons Centres and Clinical Toxicologists
• Essential information for medical purposes, esp. required quality of the composition
• Unique product (information) identifiers
• Product categorisation
• Format: SDS + additional information in XML, PDF or both
1a) Poisons Information Centres (PIC) should reach consensus on:
1b) Consultation with all stakeholders, e.g. industry, governmental authorities
• Workshop 24th november 2010
• Report summarising the state of the project
2) Determine with stakeholders the required information format
3) Implementation in an Annex to the CLP Regulation
CLP 45(4) review
EAPCCT guidelines 2010
1c) Determine with stakeholders the required information quality
Schedule
European Association of Poisons Centres and Clinical Toxicologists
EAPCCT 2010 guidelines
Presentation by Ronald de Groot
All constituents should be mentioned
Actual concentrations of any very toxic (T+), toxic (T) or corrosive (C) constituents
Concentrations of all other constituentscan be given in % concentration bands:
0 to 1%20 to 30%1 to 5%30 to 50%5 to 10% 50 to 75%10 to 20% over 75%
EAPCCT guideline 1989: composition
European Association of Poisons Centres and Clinical Toxicologists
Presentation by Ronald de Groot
EAPCCT 2010 guidelines
Signal words: danger / warning
European Association of Poisons Centres and Clinical Toxicologists
COMPANY INFORMATION- Company placing the mixture on the market- Company submitting the mixture information- Contact Point(s) in case of emergency
IDENTIFICATION OF THE MIXTURE- Mixture identifiers- Product Identification Element
COMPOSITION- Substances in the mixture- Substance concentrations - Reformulation
CATEGORISATION- Product Category- Consumer / Professional use
CLASSIFICATION- Classification- Label elements
PACKAGING- Type(s)- Size(s)- Labels
PHYSICAL/CHEMICAL CHARATERISTICS- Physical state- pH- Total reserve acidity/alkalinity
TOXICOLOGY
OTHER INFORMATION
EAPCCT 2010 guidelines
Presentation by Ronald de Groot
European Association of Poisons Centres and Clinical Toxicologists
Product (information) identification
Product Name
Product LabelProduct Information
Product Name
Product Formula
Product Name
Product FormulaProduct Name
European Association of Poisons Centres and Clinical Toxicologists
Product identification
Presentation by Axel Hahn
Product Name
Product LabelProduct Information
Product Name
Product Formula
Product Name
Product Formula
Product Identification Element
Product NameProduct Identification Element
European Association of Poisons Centres and Clinical Toxicologists
Product versioning
Presentation by Herbert Desel
Product Name
Product LabelProduct Information
Product Name
Product Formula
Product Name
Product FormulaProduct Name
Product Formula Id
Product Formula Id
European Association of Poisons Centres and Clinical Toxicologists
Product categorisation
Presentation by Andreas Stürer
● Use of a harmonised product categorisation system
● E.g. for better comparison of exposure data of products in certain categories between European Poisons Centres
● E.g. to better combine exposure data of European Poisons Centres into one european annual report
European Association of Poisons Centres and Clinical Toxicologists
Product information format
SDS Add. Info
For companies: • Convenient to use the Safety Data Sheet as part of the product information
For Poison Centres:
• Not enough information on the SDS to perform an adequate risk assessment
• Additional information needed
PC requirements
European Association of Poisons Centres and Clinical Toxicologists
Presentation by Cristophe Dupriez
Product information format
SDS
PC requirements
Add. Info
Format requirements:
• No notification of one SDS file and one file with additional information
• But notification of a SDS file and a PC electronic dataset
(containing most data of the Poisons Centres requirements)
• Electronic notification of the required dataset to PICs allows easy electronic data import, validation, presentation, statistical analysis, …
• Use of XML, PDF and/or techniques/tools
PC electronic dataset
European Association of Poisons Centres and Clinical Toxicologists
Paragraph 1Prior to placing the cosmetic product on the market the responsible
person shall submit, by electronic means, the following information to the Commission: (a list of requirements follows)
Paragraph 5The Commission shall, without delay, make the information referred to
in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.
Paragraph 6The Commission shall, without delay, make the information referred to
in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.
Cosmetic Products Notification Portal
Cosmetic products Regulation (EC) No 1223/2009
European Association of Poisons Centres and Clinical Toxicologists
European Association of Poisons Centres and Clinical Toxicologists
Lead by Dr. Aurelien Perez- June 29th 2009 1st meeting of COM, Colipa, Ind, GA, PICs - Sept 18th 2009 2nd meeting of COM, Colipa, Ind, GA, PICs
=>ad hoc WG IT-related issues (3 meetings)=>ad hoc WG categorisation (2 meetings)=>ad hoc WG Frame formulations (3 meetings)
- Jan 2011 3rd meeting of COM, Colipa, Ind, GA, PICs
- 2011 Four iterations of constructing and testing
- Jan 2012 CPNP in production
Cosmetic Products Notification Portal
Development by DG SANCO
European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues
Current activities:- Harmonisation of Product Notification: CLP 45(4) survey by COM (Uta
Jensen)lead: Ronald de Groot (NL)
- Cosmetic Products Notification Portal (CPNP) working group (Aurelien Perez)lead: Herbert Desel (DE)Ad hoc WG on IT issues lead: Pieter Brekelmans (NL)Ad hoc WG on Categorisation lead: Andreas Stürer (DE)Ad hoc WG on Frame Formulations lead: Martine Mostin (BE)
Cosmetic Products Notification Portal
European Association of Poisons Centres and Clinical Toxicologists
European Association of Poisons Centres and Clinical Toxicologists
• Essential information for medical purposes, esp. required quality of the composition
• Unique product (information) identifiers
• Product categorisation
• Format: SDS + additional information in XML, PDF or both
1a) Poisons Information Centres (PIC) should reach consensus on:
1b) Consultation with all stakeholders, e.g. industry, governmental authorities
• Workshop 24th november 2010
• Report summarising the state of the project
2) Determine with stakeholders the required information format
3) Implementation in an Annex to the CLP Regulation
CLP 45(4) review: future
EAPCCT guidelines 2010
1c) Determine with stakeholders the required information quality
Schedule
European Association of Poisons Centres and Clinical Toxicologists
