1. 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

2. 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

3. 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

4. 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

5. 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

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

7. Lessons from MAGAM Study
Oktober 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

8. 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

9. 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

10. 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

11. 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

12. 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:
European Association of Poisons Centres and Clinical Toxicologists

13. 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

14. 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

15. 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

16. 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

17. 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

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

19. CPNP*: Cosmetics Categories
[5]
*Cosmetics Products Notification Portal
Oct – 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

20. 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

21. 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

22. 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

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