1. Application of the article 45 (CLP) in France
Organisation, regulation and evolution of the French system
Application of the article 45 (CLP) in France
Caroline PAUL - French Ministry of Health -
24 November 2010

2. Organisation and actors
10 poisons and toxicovigilance centres (Centre Antipoison et de Toxicovigilance, CAPTV) and 3 toxicovigilance centres (Centre de Toxicovigilance, CTV) : 13 CAPTV included in 10 Hospitals
InVS : French Institute for Public Health Surveillance, in charge of the national coordination of toxicovigilance.
INRS : health and safety research institute
French health safety Agencies : ANSES on environmental and professional risk and food safety, AFSSAPS on health products safety
Others actors or networks linking to phytopharmaceutical products, veterinary drugs, cosmetics,…

3. CAPTV missions
Two missions defined by the public health code (article D ) :
to answer 24h/7 to public and to health professionals on toxicological risk, acute or chronic (telephonic response) ;
to ensure toxicovigilance (surveillance of acute or chronic toxic effects of a product on human health, to lead alert, prevention or information actions).
To fulfil their missions of risk evaluation of acute or chronic exposure to xenobiotics, CAPTV should have :
immediately access to compositions of chemicals,
and need database containing high-quality data.

4. Information system SICAP
The national poison centres information system (SICAP) collect data for 10 years on products and toxic exposure recorded by CAPTV :
a national database on intoxication cases (Base Nationale des Cas d’Intoxication - BNCI) million cases register during the telephonic response of CAPTV ;
a national database on products and compositions (Base Nationale des Produits et Compositions - BNPC) - composition of 200 000 agents.
The BNPC is in link with the BNCI

5. DATABASES 2 databases for chemicals :
BNPC - National basis of products and compositions (CAPTV), containing all sorts of products, overall for consumers, including all chemicals, medical drugs, poisonous animals, vegetals, mushrooms…
BNPC :
is a helpfull tool for CAPTV telephonical response,
is used for toxicovigilance (studies, statistical analysis)
SEPIA (INRS), to prevent chemical hazard and diseases for workers (industrial products, professional uses)

6. French regulation According to the French regulation, since 1992 :
precise composition of products are transmitted to CAPTV by industrials, following an exposition
industrials are obliged to transmit to INRS the precise composition of all chemicals classified as T+, T or C, including CMR categories 1 or 2, within 30 calendar days after the launch on the market.
CAPTV have access to the datas of declaration registred by INRS in SEPIA (ORFILA System).
More and more industrials transmit voluntary declarations to CAPTV.

7. DECLARATION SYNAPSE
A declarative portal called DECLARATION SYNAPSE, jointly developed by INRS and CAPTV, allow since January 2010 all industrials to make easy, quick, unique, secure and reliable product composition declarations.
Industrials could view previous declarations, update or complete them.
This portal supply the two databases SEPIA and BNPC

11. Interest of precise & exhaustive databases
To public health :
to better assess exposure (number of persons exposed)
to estimate the risk for the population, as the products are linked to the intoxication cases,
In France, CAPTV studies are available via :
To industrials who declare exhaustive and precise information to CAPTV :
they are not obliged to be on call 24h/7 to give information,
it’s a quality approach which strengthen security of their products towards consumers,
they also could be informed about poisoning cases in which their products are involved.

12. Evolutions and perspectives
France is strengthenig the toxicovigilance system :
Statutory obligation for industrials to give information on all mixtures classified as dangerous by CLP regulation (a decree is being done);
Helping and encouraging industrials to declare their composition and type of use (information, training,…);
Importing information from other databases (phytopharmaceutical products, biocides, drugs, cosmetics,…);
Using a unique identification number for mixture to ensure the good correspondence between composition and commercial name (in draft, to be discussed with others Members States).

13. PIC requirements on product information for CLP regulation article 45 according Fr
Qualitative and quantitative information,
Versioning of submitted products information,
A unique identification number for each product place on the marked, which also permit to identify each included mixture (more and more products are composed of included mixture of unknown composition),
An XML exchange format, essential to analyse data,
A categorisation of uses (to classify each product under one or several uses),
A need to know the presence of known and classified impurities.

14. To be able to find a consensus on these PIC requirements, French authorities call upon the European commission to set up a working group on harmonisation of PIC requirements on products information with persons designed by all Members States.

15. Some examples of studies (transmited to European Commission)
Dimethylfumarate
Grill lighters
Dichloromethane
Lamp oils
All Biocides (application of the biocide EU reglementation,
Glycol ethers…etc
And later : 1,4-dichlorobenzene (CMR3), with the analyse of ANSES, endocrine disruptors…etc