WORLD TRADE G/TBT/Notif.98.84
25February 1998
ORGANIZATION
(98-0764)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: FRANCE
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofHealth
Directorate-General ofHealth
8,Avenue deSégur
75007 Paris
Agency orauthority designated tohandle comments regarding thenotification shall be
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [],2.10.1 [],5.6.2 [],5.7.1 [],other: Pursuant tothe
TBTAgreement
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Health monitoring and
safety
5. Title, number ofpages andlanguage(s) ofthenotified document: (4pages)
6. Description ofcontent: Thereform establishes:
- AFrench health monitoring institute which willberesponsible for
monitoring thehealth situation ofthepopulation through public or
private correspondents, detecting anynewdevelopments thatmayaffect
public health andbringing them totheattention ofthepublic authorities.
- AFrench health products safety agency, modelled ontheDrugs Agency.
ThisAgency willberesponsible fortheevaluation andcontrol ofhealth
products orproducts claiming tobehealth products. With thisnew
Agency, control willnolonger becarried outbydifferent agencies on
thebasis ofproduct categories (drugs, cosmetics, medical devices, blood
products, organs, human tissues andcells...),products previously not
covered byregulations willbecontrolled, andawatertight separation
between production andcontrol functions willbeensured.
./.G/TBT/Notif.98.84
Page2
6. Description ofcontent (cont'd):
- AFrench food health safety agency forevaluating thehealth risks offood
products, from theproduction ofrawmaterials until their distribution tothe
end-consumer. Itwillalsodealwithconditions ofuseoffoodstuffs foranimal
feeding, veterinary drugs, anti-parasite products, fertilizing substances and
packaging insofar asthese mayinfluence therisks.
Finally, thereform groups various provisions forthedifferent health products,
namely medical devices, blood products orbiological products orrelated therapeutical
products, which willatlastberegulated.
7. Objective andrationale, including thenature ofurgent problems where applicable: Over
thelastfewyears, "health safety" hasbeenrecognized asagovernmental responsibility
inthesame wayasinternal security orexternal security. Thisfundamental development
islinked withtheoutbreak ofvarious crises thathavemarked ourcountry overthelast
15years.
While these crises haveconcerned awidevariety ofsituations, theyhavealways
involved aconfusion between theriskevaluation function -thescientific, neutral
functions ofidentifying andclarifying arisk-andtheriskmanagement function of
weighing uptheresults oftheriskevaluation andtheinterests atstake inorder to
determine policy choices relating toappropriate controls andregulatory measures.
Thereform makes useoftheexisting powers andstructures ofthehealth
services andisbased onthecurrent legislation inorder toenhance andimprove
performance.
8. Relevant documents: Basic texts plusdrafts resulting from tworeadings intheSenate
andNational Assembly.
9. Proposed dateofadoption: Spring 1998
Proposed dateofentry intoforce: End1998 andend1999
10. Final dateforcomments: 30April 1998
11. Texts available from: National enquiry point [X]oraddress, e-mail andtelefax number
ofother body: CINORTECH
Mrs. VAQUIER (AFNOR)
Tour Europe
92049 PARIS LADEFENSE