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

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
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,…
CAPTV missions
Two missions defined by the public health code (article
D. 6141-37) :
 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.
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) - 1.6
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
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)
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.
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
www.declaration-synapse.fr
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 :
http://www.centres-antipoison.net/CCTV/index.html
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.
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).
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.
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.
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