Application of the article 45 (CLP) Application of the article 45 (CLP) in Francein France

Organisation, regulation and Organisation, regulation and evolution of the French systemevolution of the French system

Caroline PAUL - French Ministry of Health - Caroline PAUL - French Ministry of Health -

24 November 201024 November 2010

Organisation and actorsOrganisation and actors

10 poisons and toxicovigilance centres (Centre Antipoison 10 poisons and toxicovigilance centres (Centre Antipoison et de Toxicovigilance, CAPTV) and 3 toxicovigilance et de Toxicovigilance, CAPTV) and 3 toxicovigilance centres (Centre de Toxicovigilance, CTV)centres (Centre de Toxicovigilance, CTV) : : 13 CAPTV13 CAPTV included in 10 Hospitalsincluded in 10 HospitalsInVSInVS : : French Institute for Public Health SurveillanceFrench Institute for Public Health Surveillance, in , in charge of the national coordination of toxicovigilance. charge of the national coordination of toxicovigilance. INRSINRS : : health and safety research institutehealth and safety research instituteFrench health safety Agencies : French health safety Agencies : ANSESANSES on environmental on environmental and professional risk and food safety, and professional risk and food safety, AFSSAPSAFSSAPS on health on health products safetyproducts safetyOthers actors or networks linking to Others actors or networks linking to phytopharmaceutical phytopharmaceutical products, veterinary drugs, cosmetics,…products, veterinary drugs, cosmetics,…

CAPTV missionsCAPTV missions

Two missions defined by the public health code (article Two missions defined by the public health code (article D. 6141-37) : D. 6141-37) : to to answer 24h/7 to public and to health professionalsanswer 24h/7 to public and to health professionals

on toxicological risk, acute or chronic (telephonic on toxicological risk, acute or chronic (telephonic response) ;response) ;

to ensure to ensure toxicovigilance toxicovigilance (surveillance of acute or (surveillance of acute or chronic toxic effects of a product on human health, to chronic toxic effects of a product on human health, to lead alert, prevention or information actions).lead alert, prevention or information actions).

To fulfil their missions of risk evaluation of acute or To fulfil their missions of risk evaluation of acute or chronic exposure to xenobiotics, CAPTV should have :chronic exposure to xenobiotics, CAPTV should have : immediately access to immediately access to compositionscompositions of chemicals, of chemicals, and need and need database containing high-quality datadatabase containing high-quality data..

Information system SICAPInformation system SICAP

The The national poison centres information national poison centres information system (SICAP)system (SICAP) collect data for 10 years on collect data for 10 years on products and toxic exposure recorded by products and toxic exposure recorded by CAPTV :CAPTV :

- a a national database on intoxication casesnational database on intoxication cases (Base (Base Nationale des Cas d’Intoxication - Nationale des Cas d’Intoxication - BNCIBNCI) - 1.6 ) - 1.6 million cases register during the telephonic million cases register during the telephonic response of CAPTV ;response of CAPTV ;

- a a national database on products and compositionsnational database on products and compositions (Base Nationale des Produits et Compositions - (Base Nationale des Produits et Compositions - BNPCBNPC) - composition of 200 000 agents.) - composition of 200 000 agents.

The BNPC is in link with the BNCIThe BNPC is in link with the BNCI

DATABASESDATABASES

2 databases for chemicals :2 databases for chemicals :- BNPCBNPC - National basis of products and - National basis of products and

compositions (CAPTV), containing all sorts of compositions (CAPTV), containing all sorts of products, overall for consumers, including all products, overall for consumers, including all chemicals, medical drugs, poisonous animals, chemicals, medical drugs, poisonous animals, vegetals, vegetals, mushroomsmushrooms……

BNPC :BNPC : is a helpfull tool for CAPTV telephonical response,is a helpfull tool for CAPTV telephonical response, is used for toxicovigilance (studies, statistical analysis)is used for toxicovigilance (studies, statistical analysis)

- SEPIASEPIA (INRS), to prevent chemical hazard and (INRS), to prevent chemical hazard and diseases for workers (industrial products, diseases for workers (industrial products, professional uses)professional uses)

French regulationFrench regulation

According to the French regulation, sAccording to the French regulation, since 1992 : ince 1992 : - precise composition of products are transmitted precise composition of products are transmitted

to CAPTVto CAPTV by industrials, by industrials, following an expositionfollowing an exposition - industrials are obliged to transmit industrials are obliged to transmit to INRSto INRS the the

precise composition of all precise composition of all chemicals classified chemicals classified as as T+, T or CT+, T or C, including CMR categories 1 or 2, , including CMR categories 1 or 2, within 30 calendar days after the launch on the within 30 calendar days after the launch on the market.market. CAPTV have access to the datas of declaration CAPTV have access to the datas of declaration registred by INRS in SEPIA (ORFILA System). registred by INRS in SEPIA (ORFILA System). More and more industrials transmit voluntary More and more industrials transmit voluntary declarations to CAPTV.declarations to CAPTV.

DECLARATION SYNAPSEDECLARATION SYNAPSE

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

www.declaration-synapse.frwww.declaration-synapse.fr

Interest of precise & exhaustive databases

To public healthTo public health : : to better assess exposure (number of persons exposed)to better assess exposure (number of persons exposed) to estimate the risk for the population, as the products are linked to estimate the risk for the population, as the products are linked

to the intoxication cases, to the intoxication cases, In France, CAPTV studies are available via : In France, CAPTV studies are available via :

http://www.centres-antipoison.net/CCTV/index.htmlhttp://www.centres-antipoison.net/CCTV/index.htmlTo industrialsTo industrials who declare exhaustive and precise who declare exhaustive and precise information to CAPTVinformation to CAPTV : :

they are not obliged to be on call 24h/7 to give information,they are not obliged to be on call 24h/7 to give information, it’s a quality approach which strengthen security of their products it’s a quality approach which strengthen security of their products

towards consumers,towards consumers, they also could be informed about poisoning cases in which their they also could be informed about poisoning cases in which their

products are involved.products are involved.

Evolutions and perspectivesEvolutions and perspectives

FFrance is strengthenig the toxicovigilance system :rance is strengthenig the toxicovigilance system :- Statutory obligation for industrials to give information on Statutory obligation for industrials to give information on

allall mixturesmixtures classified as classified as dangerousdangerous by CLP by CLP regulation (a decree is being done);regulation (a decree is being done);

- Helping and encouraging industrials to declare their Helping and encouraging industrials to declare their composition and type of use (information, training,…);composition and type of use (information, training,…);

- Importing information from other databases Importing information from other databases (phytopharmaceutical products, biocides, drugs, (phytopharmaceutical products, biocides, drugs, cosmetics,…);cosmetics,…);

- Using a unique identification number for mixture to Using a unique identification number for mixture to ensure the good correspondence between composition ensure the good correspondence between composition and commercial name (in draft, and commercial name (in draft, to be discussed to be discussed with with others Members Statesothers Members States).).

PIC requirements on product PIC requirements on product information for CLP regulation information for CLP regulation

article 45 according Frarticle 45 according Fr

Qualitative and quantitativeQualitative and quantitative information, information, VersioningVersioning of submitted products information, of submitted products information, A A unique identification number for each productunique identification number for each product place place on the marked, which also permit to identify each included on the marked, which also permit to identify each included mixture (mixture (more and more products are composed of more and more products are composed of included mixture of unknown compositionincluded mixture of unknown composition),),An An XMLXML exchange format exchange format, essential to analyse data,, essential to analyse data,A A categorisation of usescategorisation of uses (to classify each product under (to classify each product under one or several uses),one or several uses),A need to know the presence of A need to know the presence of known and classified known and classified impuritiesimpurities..

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

Some examples of studies Some examples of studies (transmited to European (transmited to European

Commission) Commission) DimethylfumarateDimethylfumarateGrill lightersGrill lightersDichloromethaneDichloromethaneLamp oilsLamp oilsAll Biocides (application of the biocide EU All Biocides (application of the biocide EU reglementation, reglementation, Glycol ethers…etcGlycol ethers…etcAnd later : 1,4-dichlorobenzene (CMR3), with And later : 1,4-dichlorobenzene (CMR3), with the analyse of ANSES, endocrine disruptors…the analyse of ANSES, endocrine disruptors…etcetc