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

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) 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 NL: only for professionals Risk analysis of acute poisonings on a secure website Chemical incidents Radiation incidents Annual reports Anti-rain sprays cause serious lung damage Tea with decoration anis causes 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) 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

European Association of Poisons Centres and Clinical Toxicologists Company Hazardous product Product information: The (hazardous) substances Their concentrations Substance information: Dose-effect-relationship - seriousness: L/M/S - symptoms - diagnostics - therapy Information request - product name - quantity - weight of patient Adequate information / advice on treatment Product notification importance Physician / Public product name Product information: The (hazardous) substances Their concentrations Poisons Centre

European Association of Poisons Centres and Clinical Toxicologists Product information Product notification Quality of information Format of information EU legislation Natl. legislation CHANGES Product information Product notification Quality of information Format of information EU legislation Natl. legislation Product notification aspects DPD 88/379/EC, article 12 DPD 1999/45/EC, article 17 by CLP Regulation (EC) No 1272/2008, article 45

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 C lassification, L abelling and P ackaging 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: NetherlandsItalyNorway GermanyIrelandSweden BelgiumSwitzerlandDenmark FranceSpainEstonia EAPCCT working group 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 Categorisationlead: Andreas Stürer (DE) Ad hoc WG on Frame Formulationslead: Martine Mostin (BE) EAPCCT working group European Association of Poisons Centres and Clinical Toxicologists

Lead by Dr. Uta Jensen-Korte - Sept 18th 2009Introductory meeting - March 17th st meeting of COM and PIC representatives - May 28th nd meeting of COM, PIC and some GA representatives - June 17th 2010Caracal meeting (EC) - Aug 20103rd meeting with PIC representatives - Sept 2010endorsed draft of EAPCCT 2010 guidelines - Nov 24th 2010Workshop 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 c) 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 constituents can 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 Formula Product 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 Name Product 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 Formula Product Name 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 1 Prior 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 5 The 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 6 The 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 Cosmetic Products Notification Portal Prototyping

European Association of Poisons Centres and Clinical Toxicologists Lead by Dr. Aurelien Perez - June 29th 20091st meeting of COM, Colipa, Ind, GA, PICs - Sept 18th nd 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 20113rd meeting of COM, Colipa, Ind, GA, PICs Four iterations of constructing and testing - Jan 2012CPNP 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 Categorisationlead: Andreas Stürer (DE) Ad hoc WG on Frame Formulationslead: Martine Mostin (BE) Cosmetic Products Notification Portal 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 c) Determine with stakeholders the required information quality Schedule

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) PIF Datafiles KOS files Sysdecos PINDA SDS ProdInfo Dangerous Preparations Directive (88/379 art.12; 1999/45 art. 17) Cosmetics Directive (76/768) SDS Directive (91/155; 2001/58) Biocides Directive (98/8 art. 23) Preparationsdatabase Past situation T, T+, C

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) Exact concentrations (all ingredients) or Exact concentrations (T, T+, C, Xi, Xn ingr.) Well specified ranges (other ingredients) or Well specified ranges (all ingredients) Complete composition (no thresholds) SDS.pdf + Composition.pdf Present situation

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) PIF Datafiles KOS files SDS comp. pdf Preparationsdatabase Sysdecos PINDA SDS ProdInfo Dangerous Preparations Directive (88/379 art.12; 1999/45 art. 17) Cosmetics Directive (76/768) SDS Directive (91/155; 2001/58) Biocides Directive (98/8 art. 23) Present situation

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) KOS files SDS comp. pdf Preparationsdatabase Sysdecos Dangerous Preparations Directive (88/379 art.12; 1999/45 art. 17) Cosmetics Directive (76/768) Biocides Directive (98/8 art. 23) Present situation

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) datafiles SDS comp. CLP.XML pdf CPNP CLP Regulation (1272/2008) Notification of hazardous mixtures incl. biocides incl. plant protection products Cosmetics Regulation (1223/2009) CosmProd.XML Mixtures database Future situation

European Association of Poisons Centres and Clinical Toxicologists Future (a Dutch perspective) datafiles Have good quality product information available right at the doorstep of the poisons information centre Make use of one format/standard for exchange of product information within the EU for all products EUProdNot.XML Mixtures database Future situation

European Association of Poisons Centres and Clinical Toxicologists All for one, one for all