WORLD TRADE G/TBT/Notif.97.382
6August 1997
ORGANIZATION
(97-3331)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: EUROPEAN COMMUNITY
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: European Commission
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Products containing or
consisting ofgenetically modified organisms (GMOs).
5. Title, number ofpages andlanguage(s) ofthenotified document: Commission
Directive 97/35/EC of18June 1997 Adapting toTechnical Progress fortheSecond
Time Council Directive 90/220/EEC ontheDeliberate Release intotheEnvironment of
Genetically Modified Organisms (2pages)
6. Description ofcontent: TheDirective extends theinformation requirements ofAnnex III
sothatnotifiers willinthefuture include intheirdossiers:
(a) specific labelfortheGMOs theyintend toplace onthemarket aswellas
(b) molecular datainaform which canbeincluded inapotential register.
7. Objective and rationale: The Commission Directive amends Annex IIIto
Directive 90/220/EEC inorder tofacilitate theriskassessment ofproducts containing or
consisting ofGMOs.
Therational isthefollowing:
Products cleared under Directive 90/220/EEC areassessed fortheir safety to
human health andtheenvironment. Once approved, theycancirculate freely within the
Community thusbecoming partoftheenvironment.
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7. Objective andrationale: (cont'd)
Anyriskassessment foragiven GMO tobeplaced onthemarket hastotake
intoaccount potential interactions oftheGMO inquestion withother organisms inthe
environment, including other GMOs already approved forplacing onthemarket. Itisto
beexpected thatasthenumber ofauthorized GMO products increases, sowillthe
complexity oftheriskassessment fortheplacing onthemarket offurther GMOs. Thus,
aregister/database onmolecular information concerning modifications already introduced
inorganisms willcertainly become necessary forcarrying outenvironmental risk
assessment inthefuture.
Furthermore, anydatagenerated during post-release observation ofGMOs will
greatly facilitate theriskassessment task. Inturn, thegeneration ofsuchdatawillbe
greatly facilitated byspecific labelling ofGMOs already cleared forplacing onthe
market under theDirective.
8. Relevant documents: Official Journal oftheEuropean Communities No.L169,
27June1997, p.72.
9. Proposed dateofadoption: 18June1997
Proposed dateofentry intoforce: 28June1997
10. Final dateforcomments: 30September 1997
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: DGIII-A-1