Andreas Stürer, MD Swiss Toxicological Information Centre Switzerland Product Categorisation Andreas Stürer, MD Swiss Toxicological Information Centre Switzerland 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

European Association of Poisons Centres and Clinical Toxicologists Agenda Necessity and usage of categories in poisons centres Does industry need product categories? – Lessons we learned from the MAGAM study Process of categorisation within European PCs Experience of the TDI project and the Klinitox working group „Categorisation Systems“ CPNP: joint venture COLIPA – PCs – an example of harmonised product categories MAGAM group: first draft version of harmonised detergents categories Conclusions European Association of Poisons Centres and Clinical Toxicologists

Categorisation Systems in PCs [1] CSA Categorisation System for Agents Retrieval of product information for risk assessment during consultation Index of product names and identifiers Recording of cases linked to the exposed products ~ 100‘000 – 1‘000‘000 documents about products/ agents in databases ~ 10‘000 – 100‘000 cases/y European Association of Poisons Centres and Clinical Toxicologists

Integration of CSA in PCs Categorisation System for Agents Detergents ADW Retrieval of product information for risk assessment during consultation Index of product names and identifiers Recording of cases linked to the exposed products Detergents Products Autom. DishW. Cases with exposure to detergents products Product informations for detergents products automatic dishwashing p. automatic dishwashing p. European Association of Poisons Centres and Clinical Toxicologists

Usage of CSA in PCs CSA processing of new product information 1st registration of products CSA Categorisation System for Agents Retrieval of product information for risk assessment during consultation Index of product names and identifiers Recording of cases linked to the exposed products retrieval of case series for scientific studies retrieval of comparable products annual reports PCs need CSA for their daily job ! European Association of Poisons Centres and Clinical Toxicologists

Industry Need Categories? [2] No!? , but … European Association of Poisons Centres and Clinical Toxicologists

Lessons from MAGAM Study Oktober 2008 11 PCs in DE, AT and CH launched the MAGAM-Study* supported by the IKW (German Cosmetic, Toiletry, Perfumery and Detergent Association; Frankfurt/Main) * MULTINATIONAL, RETROSPEKTIVE ANALYSIS OF POISONS CENTRES DATA ON THE QUESTION OF CORROSIVE EYE LESIONS CAUSED BY SOLID AUTOMATIC DISHWASHING PRODUCTS AND OTHER DETERGENTS AND MAINTENANCE PRODUCTS European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists MAGAM: Questions Do solid automatic dishwashing products (powder or tabs) and other detergents and cleaning products, exploited for domestic use, cause severe or permanent eye lesions? What is the correct classification and labelling for solid household automatic dishwashing (ADW) products? =Cat. =Cat. + = ? CLP 1272/2008 EC new Directive 1999/45 EC previous =Cat. Are poisons centres’ data suitable for expert judgement within CLP? European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists MAGAM: Methods Product / Case Identification in 11 individual PCs A, D, CH: harmonised CSA „TDI Categorisation System for Agents“ -> 6 categories Problem: 1998 – 2007 categorisation was done independently by each PC Consequence: due to entirely different categories allocation of products to the listet 6 categories took 6 months more than expected European Association of Poisons Centres and Clinical Toxicologists

Household ADW Products MAGAM: Results ADW   Household ADW Products Severity Grading [PSS] Cases % asymptomatic 29 25 minor symptoms 74 63 moderate symptoms 1 severe symptoms unknown 13 11 TOTAL 117 100 European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists MAGAM: Conclusions ADW Due to the dataset of 11 PCs no serious eye damage can be expected as a result of eye exposure to solid household automatic dishwashing products Hazard category 2, „eye irritation“ with the symbol GHS07 (exclamation mark) seems to be an adequate classification and labelling PC data can provide a solid basis of expert judgement for CLP European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists MAGAM: Future Aspects Product names, product categories and unique identifiers should be transferred electronically to PCs before consultation to improve the quality of risk assessment, patients management and case recording MAGAM Study: www.klinitox.de/263.0.html European Association of Poisons Centres and Clinical Toxicologists

Process of Categorisation [3] Actual situation in the EU PCs: Categorisation of products is done by each PC independently Product information (+ categories) is obtained from the inquirer (physician or exposed person) Product information (+ categories) is obtained from industry (before or after consultation) EU PCs use different categorisation systems Industry and PCs don‘t have uniform CSA Very difficult / not feasible to perform multicentre case studies due to entirely different categories European Association of Poisons Centres and Clinical Toxicologists

Experience of TDI* Project [4] *Toxicological Documentation and Information Network Research project 1999 – 2006 10 German PCs + Federal Institute for Risk Assessment (BfR, D) 2 results: uniform format and electronic transfer of structured product information form industry to BfR and PCs harmonised Categorisation System for Agents Sept. 2006: First version of CSA (~15‘000 cat.) European Association of Poisons Centres and Clinical Toxicologists

TDI CSA: Structure Content: comprehensive Cosmetics (COLIPA+ EAPCCT) Plants LEVEL Drugs (ATC-code WHO) L-1 L-2 L-3 L-4 L-5 L-6 L-7 L-8 L-9 Content: comprehensive SECTOR Detergents … European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists TDI CSA: Structure retrieval (daily work) hierarchical structure (tree) technical link (non-ambiguous) Technique: simple European Association of Poisons Centres and Clinical Toxicologists

Klinitox* WG „Categorisation“ *Society of Clinical Toxicology of the German speaking PCs 2007: having finished the TDI project a new Klinitox working group begun the further development of the TDI Categorisation System for Agents (CSA) 2008: version 2, ~18‘000 categories 2010: 11 PCs in A, CH, D use the TDI CSA fully integrated the common CSA built interfaces to local categorisation systems Oct.: start of data collection for a common annual report European Association of Poisons Centres and Clinical Toxicologists

Klinitox: Common Annual Report Human Exposure 2009 6/11 PCs: Berlin Erfurt Freiburg Göttingen Munich Zurich preliminary data ! European Association of Poisons Centres and Clinical Toxicologists

CPNP*: Cosmetics Categories [5] *Cosmetics Products Notification Portal Oct. 2009 – Oct. 2010: European PCs and COLIPA elaborated common categories for cosmetics products (301 categories) within an EC working group The project will be finalised in 2011 due to the revision of the frame formulations 2012: EU cosmetics industry will classify all products with common categorisation system during notification All EU PCs will get structured electronically transmitted data on cosmetics products with uniform categories European Association of Poisons Centres and Clinical Toxicologists

CLP: Detergents Categories [6] January 2010: MAGAM group started harmonisation of categories for detergents and maintenance products MAGAM group: IKW (German Cosmetic, Toiletry, Perfumery and Detergent Association; Frankfurt/Main => domestic products) IHO (German Association for Hygiene and Surfaceprotection; Frankfurt/Main => industrial products) BfR (Federal Institute for Risk Assessment, Berlin) Klinitox (Society of Clinical Toxicology Germ. speaking PCs) 20 Nov. 2010: first draft harmonised version [DE/EN] of detergents products categories => www/klinitox.de/263.0.html European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists Conclusions [7] Poisons centres need categories Industry and PCs should use uniform product categories Categorisation of products should be performed by the manufacturer / notifier Categories (+ other product inform.) should be transmitted electronically in a structured manner Quality of patient care will improve Data analysis will be easily performed European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists Conclusions Categorisation systems should be harmonised by the EAPCCT in cooperation with the industrial associations (e.g.: detergents products (AISE), coatings products (European Coatings), …) The draft version of detergents products categories (MAGAM group) could serve as a base for harmonisation on EU level EC should provide suitable conditions for the harmonisation process Time is ready to harmonise categories ! European Association of Poisons Centres and Clinical Toxicologists

European Association of Poisons Centres and Clinical Toxicologists Thank You QUESTIONS ? European Association of Poisons Centres and Clinical Toxicologists