1830欧盟第1830号指令.docx

1830欧盟第1830号指令.docx

《1830欧盟第1830号指令.docx》由会员分享，可在线阅读，更多相关《1830欧盟第1830号指令.docx（11页珍藏版）》请在冰豆网上搜索。

1830欧盟第1830号指令

Regulation（EC）No1830/2003oftheEuropeanParliamentandoftheCouncil

of22September2003

concerningthetraceabilityandlabellingofgeneticallymodifiedorganismsandthetraceabilityoffoodandfeedproductsproducedfromgeneticallymodifiedorganismsandamendingDirective2001/18/EC

THEEUROPEANPARLIAMENTANDTHECOUNCILOFTHEEUROPEANUNION,

HavingregardtotheTreatyestablishingtheEuropeanCommunity,andinparticularArticle95

（1）thereof,HavingregardtotheproposalfromtheCommission

（1）,HavingregardtotheopinionoftheEuropeanEconomicandSocialCommittee

（2）,HavingregardtotheopinionoftheCommitteeoftheRegions（3）,ActinginaccordancewiththeprocedurelaiddowninArticle251oftheTreaty（4）,

Whereas:

（1）Directive2001/18/ECoftheEuropeanParliamentandoftheCouncilof12March2001onthedeliberatereleaseintotheenvironmentofgeneticallymodifiedorganisms（5）requiresMemberStatestotakemeasurestoensuretraceabilityandlabellingofauthorisedgeneticallymodifiedorganisms（GMOs）atallstagesoftheirplacingonthemarket.

（2）Differencesbetweennationallaws,regulationsandadministrativeprovisionsconcerningtraceabilityandlabellingofGMOsasproductsorinproductsaswellastraceabilityoffoodandfeedproducedfromGMOsmayhindertheirfreemovement,creatingconditionsofunequalandunfaircompetition.AharmonisedCommunityframeworkfortraceabilityandlabellingofGMOsshouldcontributetotheeffectivefunctioningoftheinternalmarket.Directive2001/18/ECshouldthereforebeamendedaccordingly.

（3）TraceabilityrequirementsforGMOsshouldfacilitateboththewithdrawalofproductswhereunforeseenadverseeffectsonhumanhealth,animalhealthortheenvironment,includingecosystems,areestablished,andthetargetingofmonitoringtoexaminepotentialeffectson,inparticular,theenvironment.Traceabilityshouldalsofacilitatetheimplementationofriskmanagementmeasuresinaccordancewiththeprecautionaryprinciple.

（4）TraceabilityrequirementsforfoodandfeedproducedfromGMOsshouldbeestablishedtofacilitateaccuratelabellingofsuchproducts,inaccordancewiththerequirementsofRegulation（EC）No1829/2003oftheEuropeanParliamentandoftheCouncilof22September2003ongeneticallymodifiedfoodandfeed（6）,soastoensurethataccurateinformationisavailabletooperatorsandconsumerstoenablethemtoexercisetheirfreedomofchoiceinaneffectivemanneraswellastoenablecontrolandverificationoflabellingclaims.RequirementsforfoodandfeedproducedfromGMOsshouldbesimilarinordertoavoiddiscontinuityofinformationincasesofchangeinenduse.

（5）ThetransmissionandholdingofinformationthatproductscontainorconsistofGMOs,andtheuniquecodesforthoseGMOs,ateachstageoftheirplacingonthemarketprovidethebasisforappropriatetraceabilityandlabellingforGMOs.ThecodesmaybeusedtoaccessspecificinformationonGMOsfromaregister,andtofacilitatetheiridentification,detectionandmonitoringinaccordancewithDirective2001/18/EC.

（6）ThetransmissionandholdingofinformationthatfoodandfeedhavebeenproducedfromGMOsalsoprovidethebasisfortheappropriatetraceabilityofproductsproducedfromGMOs.

（7）TheCommunitylegislationconcerningGMOsasorinfeedshouldalsoapplytofeedintendedforanimalswhicharenotdestinedforfoodproduction.

（8）Guidanceonsamplinganddetectionshouldbedevelopedinordertofacilitateacoordinatedapproachforcontrolandinspectionandprovidelegalcertaintyforoperators.AccountshouldbetakenofregisterscontaininginformationongeneticmodificationsinGMOsestablishedbytheCommissioninaccordancewithArticle31

（2）ofDirective2001/18/ECandArticle29ofRegulation（EC）No1829/2003.

（9）MemberStatesshouldlaydownrulesonpenaltiesapplicabletoinfringementsoftheprovisionsofthisRegulation.

（10）CertaintracesofGMOsinproductsmaybeadventitious（外来的、偶然的）ortechnicallyunavoidable.SuchpresenceofGMOsshouldthereforenottriggerlabellingandtraceabilityrequirements.Itisthereforenecessarytofixthresholdsfortheadventitiousortechnicallyunavoidablepresenceofmaterialconsisting,containingorproducedfromGMOsbothwhenthemarketingofsuchGMOsisauthorisedintheCommunityandwhentheiradventitiousortechnicallyunavoidablepresenceistoleratedbyvirtueofArticle47ofRegulation（EC）No1829/2003.Itisalsoappropriatetoprovidethat,whenthecombinedlevelofadventitiousortechnicallyunavoidablepresenceoftheabovematerialinafoodorfeedorinoneofitscomponentsishigherthantheaforesaidlabellingthresholds,suchpresenceshouldbeindicatedinaccordancewiththeprovisionsofthisRegulationanddetailedprovisionstobeadoptedforitsimplementation.

（11）ItisnecessarytoensurethatconsumersarefullyandreliablyinformedaboutGMOsandtheproducts,foodsandfeedproducedtherefrom,soastoallowthemtomakeaninformedchoiceofproduct.

（12）ThemeasuresnecessaryfortheimplementationofthisRegulationshouldbeadoptedinaccordancewithCouncilDecision1999/468/ECof28June1999layingdowntheproceduresfortheexerciseofimplementingpowersconferredontheCommission（7）.

（13）SystemsforthedevelopmentandassignmentofuniqueidentifiersforGMOsshouldbeestablishedbeforethemeasuresrelatingtotraceabilityandlabellingcanbeapplied.

（14）TheCommissionshouldsubmitareporttotheEuropeanParliamentandtheCouncilontheimplementationofthisRegulationand,morespecifically,ontheeffectivenessoftherulesontraceabilityandlabelling.

（15）ThisRegulationrespectsthefundamentalrightsandobservestheprinciplesrecognisedinparticularbytheCharterofFundamentalRightsoftheEuropeanUnion,

HAVEADOPTEDTHISREGULATION:

Article1

Objectives

ThisRegulationprovidesaframeworkforthetraceabilityofproductsconsistingoforcontaininggeneticallymodifiedorganisms（GMOs）,andfoodandfeedproducedfromGMOs,withtheobjectivesoffacilitatingaccuratelabelling,monitoringtheeffectsontheenvironmentand,whereappropriate,onhealth,andtheimplementationoftheappropriateriskmanagementmeasuresincluding,ifnecessary,withdrawalofproducts.

Article2

Scope

1.ThisRegulationshallapply,atallstagesoftheplacingonthemarket,to:

（a）productsconsistingof,orcontaining,GMOs,placedonthemarketinaccordancewithCommunitylegislation;

（b）foodproducedfromGMOs,placedonthemarketinaccordancewithCommunitylegislation;

（c）feedproducedfromGMOs,placedonthemarketinaccordancewithCommunitylegislation.

2.ThisRegulationshallnotapplytomedicinalproductsforhumanandveterinaryuseauthorisedunderRegulation（EEC）No2309/93（8）.

Article3

Definitions

ForthepurposeofthisRegulation:

1."Geneticallymodifiedorganism"or"GMO"meansgeneticallymodifiedorganismasdefinedinArticle2

（2）ofDirective2001/18/EC,excludingorganismsobtainedthroughthetechniquesofgeneticmodificationlistedinAnnexIBtoDirective2001/18/EC;

2."ProducedfromGMOs"meansderived,inwholeorinpart,fromGMOs,butnotcontainingorconsistingofGMOs;

3."Traceability"meanstheabilitytotraceGMOsandproductsproducedfromGMOsatallstagesoftheirplacingonthemarketthroughtheproductionanddistributionchains;

4."Uniqueidentifier"meansasimplenumericoralphanumericcodewhichservestoidentifyaGMOonthebasisoftheauthorisedtransformationeventfromwhichitwasdevelopedandprovidingthemeanstoretrievespecificinformationpertinenttothatGMO;

5."Operator"meansanaturalorlegalpersonwhoplacesaproductonthemarketorwhoreceivesaproductthathasbeenplacedonthemarketintheCommunity,eitherfromaMemberStateorfromathirdcountry,atanystageoftheproductionanddistributionchain,butdoesnotincludethefinalconsumer;

6."Finalconsumer"meanstheultimateconsumerwhowillnotusetheproductaspartofanybusinessoperationoractivity;

7."Food"meansfoodasdefinedinArticle2ofRegulation（EC）No178/2002（9）;

8."Ingredient"meansingredientasreferredtoinArticle6（4）ofDirective2000/13/EC（10）;

9."Feed"meansfeedasdefinedinArticle3（4）ofRegulation（EC）No178/2002;

10."Placingonthemarket"meansplacingonthemarketasdefinedinthespecificCommunitylegislationunderwhichtherelevantproducthasbeenauthorised;inothercases,itisdefinedasinArticle2（4）ofDirective2001/18/EC;

11."Thefirststageoftheplacingonthemarketofaproduct"meanstheinitialtransactionintheproductionanddistributionchains,whereaproductismadeavailabletoathirdparty;

12."Pre-packagedproduct"meansanysingleitemofferedforsaleconsistingofaproductandthepackagingintowhichitwasputbeforebeingofferedforsale,whethersuchpackagingenclosestheproductcompletelyoronlypartially,providedthatthecontentscannotbealteredwithoutopeningorchangingthepackaging.

Article4

TraceabilityandlabellingrequirementsforproductsconsistingoforcontainingGMOs

A.TRACEABILITY

1.AtthefirststageoftheplacingonthemarketofaproductconsistingoforcontainingGMOs,includingbulkquantities,operatorsshallensurethatthefollowinginformationistransmittedinwritingtotheoperatorreceivingtheproduct:

（a）thatitcontainsorconsistsofGMOs;

（b）theuniqueidentifier（s）assignedtothoseGMOsinaccordancewithArticle8.

2.Atallsubsequentstagesoftheplacingonthemarketofproductsreferredtoinparagraph1,operatorsshallensurethattheinformationreceivedinaccordancewithparagraph1istransmittedinwriti