european association of poisons centres and clinical toxicologists andreas stürer, md swiss...

European Association of Poisons Centres and Clinical Toxicologists

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

Product Categorisation


Agenda

1. Necessity and usage of categories in poisons centres

2. Does industry need product categories? – Lessons we learned from the MAGAM study

3. Process of categorisation within European PCs

4. Experience of the TDI project and the Klinitox working group „Categorisation Systems“

5. CPNP: joint venture COLIPA – PCs – an example of harmonised product categories

6. MAGAM group: first draft version of harmonised detergents categories

7. Conclusions


Index of product namesand identifiers

Retrieval of product information for risk assessment during consultation

CSACategorisation

System for Agents

Recording of cases linked to the

exposed products

Categorisation Systems in PCs

~ 10‘000 – 100‘000 cases/y

~ 100‘000 – 1‘000‘000documents about products/

agents in databases

[1]




CSACategorisation

System for Agents


exposed products

Deterg

ents

Detergents

Products Cases with exposure to

detergents products Product informations fordetergents products

AD

WA

uto

m. D

ish

W. automatic dishwashing p.automatic dishwashing p.

Integration of CSA in PCs


Usage of CSA in PCs

processing of new product information



retrieval of comparable

products

1st registration of products

annual reports

retrieval of caseseries for scientific

studies

CSACategorisation

System for Agents


exposed products

PCs need CSA for their daily job !


Industry Need Categories?

No!? , but …

[2]


Lessons from MAGAM Study

* 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

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)


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?

Are poisons centres’ data suitable for expert judgement within CLP?

+ = ? CLP 1272/2008 EC

new

Directive 1999/45 EC

previous

?

?

=Cat.

=Cat.

=Cat.


MAGAM: Methods

A, D, CH:harmonised CSA„TDI Categorisation System for Agents“-> 6 categories

Problem:1998 – 2007 categorisation was done independently by each PC

Product / Case Identification in 11 individual PCs

Consequence: due to entirely different categories allocation of products to the listet 6 categories took 6 months more than expected


MAGAM: Results

Household ADW

Products

Severity Grading [PSS] Cases %

asymptomatic 29 25

minor symptoms 74 63

moderate symptoms 1 1

severe symptoms 0 0

unknown 13 11

TOTAL 117 100

ADW


MAGAM: Conclusions

PC data can provide a solid basis of expert judgement for CLP

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

ADW


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


Process of Categorisation

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

[3]


Experience of TDI* Project

*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.)

[4]


TDI CSA: Structure

L-1 L-2 L-3 L-4 L-5 L-6 L-7 L-8 L-9

Plants

Cosmetics(COLIPA+EAPCCT)

Drugs (ATC-code WHO)

Detergents

SECTOR

LEVEL

Content:

compre

hensive

…


TDI CSA: Structure

technical link (non-ambiguous)

retrieval (daily work)

hierarchical structure (tree) Technique:

simple


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


Klinitox: Common Annual Report

Human Exposure 2009

6/11 PCs: Berlin Erfurt Freiburg Göttingen Munich Zurich

preliminary data !


CPNP*: Cosmetics Categories

*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

[5]


CLP: Detergents Categories

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

[6]


Conclusions

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

[7]


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 !


Thank You

QUESTIONS ?

european association of poisons centres and clinical toxicologists andreas stürer, md swiss...

Documents

categorisation of products

product categorisation

european pcs

clinical toxicologists

products agents

exposed products pcs

poisons centres clp

poisons centres data