EC-1830-2003--欧盟转基因食品法规.pdf

REGULATION(EC)No 1830/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 22 September 2003concerning the traceability and labelling of genetically modified organisms and the traceability offood and feed products produced from genetically modified organisms and amending Directive2001/18/ECTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,Having regard to the Treaty establishing the European Com-munity,and in particular Article 95(1)thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Economic andSocial Committee(2),Having regard to the opinion of the Committee of theRegions(3),Acting in accordance with the procedure laid down in Article251 of the Treaty(4),Whereas:(1)Directive 2001/18/EC of the European Parliament and ofthe Council of 12 March 2001 on the deliberate releaseinto the environment of genetically modified organ-isms(5)requires Member States to take measures toensure traceability and labelling of authorised geneticallymodified organisms(GMOs)at all stages of their placingon the market.(2)Differencesbetweennationallaws,regulationsandadministrative provisions concerning traceability andlabelling of GMOs as products or in products as well astraceability of food and feed produced from GMOs mayhinder their free movement,creating conditions ofunequal and unfair competition.A harmonised Commu-nity framework for traceability and labelling of GMOsshould contribute to the effective functioning of theinternal market.Directive 2001/18/EC should thereforebe amended accordingly.(3)Traceability requirements for GMOs should facilitateboth the withdrawal of products where unforeseenadverse effects on human health,animal health or theenvironment,including ecosystems,are established,andthe targeting of monitoring to examine potential effectson,in particular,the environment.Traceability shouldalso facilitate the implementation of risk managementmeasuresinaccordancewiththeprecautionaryprinciple.(4)Traceability requirements for food and feed producedfrom GMOs should be established to facilitate accuratelabelling of such products,in accordance with therequirements of Regulation(EC)No 1829/2003 of theEuropeanParliamentandoftheCouncilof22September 2003 on genetically modified food andfeed(6),so as to ensure that accurate information isavailable to operators and consumers to enable them toexercise their freedom of choice in an effective manneras well as to enable control and verification of labellingclaims.Requirements for food and feed produced fromGMOs should be similar in order to avoid discontinuityof information in cases of change in end use.(5)Thetransmission and holding of information thatproducts contain or consist of GMOs,and the uniquecodes for those GMOs,at each stage of their placing onthe market provide the basis for appropriate traceabilityand labelling for GMOs.The codes may be used toaccess specific information on GMOs from a register,and to facilitate their identification,detection and moni-toring in accordance with Directive 2001/18/EC.(6)The transmission and holding of information that foodand feed have been produced from GMOs also providethe basis for the appropriate traceability of productsproduced from GMOs.(7)The Community legislation concerning GMOs as or infeed should also apply to feed intended for animalswhich are not destined for food production.(8)Guidance on sampling and detection should be devel-oped in order to facilitate a coordinated approach forcontrol and inspection and provide legal certainty foroperators.Accountshouldbetakenofregisterscontaining information on genetic modifications inGMOs established by the Commission in accordancewith Article 31(2)of Directive 2001/18/EC and Article29 of Regulation(EC)No 1829/2003.(9)Member States should lay down rules on penaltiesapplicable to infringements of the provisions of thisRegulation.18.10.2003L 268/24Official Journal of the European UnionEN(1)OJ C 304 E,30.10.2001,p.327 and OJ C 331 E,31.12.2002,p.308.(2)OJ C 125,27.5.2002,p.69.(3)OJ C 278,14.11.2002,p.31.(4)Opinion of the European Parliament of 3 July 2002(not yetpublished in the Official Journal),Council Common Position of 17March 2003(OJ C 113 E,13.5.2003,p.21),Decision of theEuropean Parliament of 2 July 2003(not yet published in the Offi-cial Journal)and Council Decision of 22 July 2003.(5)OJ L 106,17.4.2001,p.1.Directive as last amended by CouncilDecision 2002/811/EC(OJ L 280,18.10.2002,p.27).(6)See page 1 of this Official Journal.(10)Certain traces of GMOs in products may be adventitiousor technically unavoidable.Such presence of GMOsshould therefore not trigger labelling and traceabilityrequirements.It is therefore necessary to fix thresholdsfor the adventitious or technically unavoidable presenceof material consisting,containing or produced fromGMOs both when the marketing of such GMOs isauthorised in the Community and when their adventi-tious or technically unavoidable presence is tolerated byvirtue of Article 47 of Regulation(EC)No 1829/2003.Itis also appropriate to provide that,when the combinedlevel of adventitious or technically unavoidable presenceof the above material in a food or feed or in one of itscomponents is higher than the aforesaid labelling thresh-olds,such presence should be indicated in accordancewith the provisions of this Regulation and detailedprovisions to be adopted for its implementation.(11)It is necessary to ensure that consumers are fully andreliably informed about GMOs and the products,foodsand feed produced therefrom,so as to allow them tomake an informed choice of product.(12)The measures necessary for the implementation of thisRegulationshould beadopted inaccordancewithCouncil Decision 1999/468/EC of 28 June 1999 layingdown the procedures for the exercise of implementingpowers conferred on the Commission(1).(13)Systems for the development and assignment of uniqueidentifiers for GMOs should be established before themeasures relating to traceability and labelling can beapplied.(14)TheCommissionshouldsubmitareporttotheEuropean Parliament and the Council on the implemen-tation of this Regulation and,more specifically,on theeffectiveness of the rules on traceability and labelling.(15)This Regulation respects the fundamental rights andobserves the principles recognised in particular by theCharter of Fundamental Rights of the European Union,HAVE ADOPTED THIS REGULATION:Article 1ObjectivesThis Regulation provides a framework for the traceability ofproducts consisting of or containing genetically modifiedorganisms(GMOs),and food and feed produced from GMOs,with the objectives of facilitating accurate labelling,monitoringthe effects on the environment and,where appropriate,onhealth,and the implementation of the appropriate risk manage-ment measures including,if necessary,withdrawal of products.Article 2Scope1.This Regulation shall apply,at all stages of the placing onthe market,to:(a)products consisting of,or containing,GMOs,placed on themarket in accordance with Community legislation;(b)food produced from GMOs,placed on the market in accor-dance with Community legislation;(c)feed produced from GMOs,placed on the market in accor-dance with Community legislation.2.This Regulation shall not apply to medicinal products forhuman and veterinary use authorised under Regulation(EEC)No 2309/93(2).Article 3DefinitionsFor the purpose of this Regulation:1.Genetically modified organism or GMO means geneti-cally modified organism as defined in Article 2(2)of Direc-tive 2001/18/EC,excluding organisms obtained throughthe techniques of genetic modification listed in Annex IBto Directive 2001/18/EC;2.Produced from GMOs means derived,in whole or in part,from GMOs,but not containing or consisting of GMOs;3.Traceability means the ability to trace GMOs and productsproduced from GMOs at all stages of their placing on themarket through the production and distribution chains;4.Unique identifier means a simple numeric or alphanu-meric code which serves to identify a GMO on the basis ofthe authorised transformation event from which it wasdeveloped and providing the means to retrieve specificinformation pertinent to that GMO;5.Operator means a natural or legal person who places aproduct on the market or who receives a product that hasbeen placed on the market in the Community,either froma Member State or from a third country,at any stage ofthe production and distribution chain,but does not includethe final consumer;18.10.2003L 268/25Official Journal of the European UnionEN(1)OJ L 184,17.7.1999,p.23.(2)Council Regulation(EEC)No 2309/93 of 22 July 1993 laying downCommunity procedures for the authorisation and supervision ofmedicinal products for human and veterinary use and establishing aEuropean Agency for the Evaluation of Medicinal products(OJ L214,24.8.1993,p.1).Regulation as last amended by Regulation(EC)No 807/2003(OJ L 122,16.5.2003,p.36).6.Final consumer means the ultimate consumer who willnot use the product as part of any business operation oractivity;7.Food means food as defined in Article 2 of Regulation(EC)No 178/2002(1);8.Ingredient means ingredient as referred to in Article 6(4)of Directive 2000/13/EC(2);9.Feed means feed as defined in Article 3(4)of Regulation(EC)No 178/2002;10.Placing on the market means placing on the market asdefined in the specific Community legislation under whichthe relevant product has been authorised;in other cases,itis defined as in Article 2(4)of Directive 2001/18/EC;11.The first stage of the placing on the market of a productmeans the initial transaction in the production and distri-bution chains,where a product is made available to a thirdparty;12.Pre-packaged product means any single item offered forsale consisting of a product and the packaging into whichit was put before being offered for sale,whether suchpackagingenclosestheproductcompletelyoronlypartially,provided that the contents cannot be alteredwithout opening or changing the packaging.Article 4Traceabilityandlabellingrequirementsforproductsconsisting of or containing GMOsA.TRACEABILITY1.At the first stage of the placing on the market of aproduct consisting of or containing GMOs,including bulkquantities,operators shall ensure that the following informationis transmitted in writing to the operator receiving the product:(a)that it contains or consists of GMOs;(b)the unique identifier(s)assigned to those GMOs in accor-dance with Article 8.2.At all subsequent stages of the placing on the market ofproducts referred to in paragraph 1,operators shall ensure thatthe information received in accordance with paragraph 1 istransmitted in writing to the operators receiving the products.3.In the case of products consisting of or containingmixtures of GMOs to be used only and directly as food or feedor for processing,the information referred to in paragraph 1(b)may be replaced by a declaration of use by the operator,accompanied by a list of the unique identifiers for all thoseGMOs that have been used to constitute the mixture.4.Without prejudice to Article 6,operators shall have inplace systems and standardised procedures to allow the holdingof information specified in paragraphs(1),(2)and(3)and theidentification,for a period of five years from each transaction,of the operator by whom and the operator to whom theproducts referred to in paragraph 1 have been made available.5.Paragraphs 1 to 4 shall be without prejudice to otherspecific requirements in Community legislation.B.LABELLING6.For products consisting of or containing GMOs,operatorsshall ensure that:(a)for pre-packaged products consisting of,or containingGMOs,the words This product contains genetically modi-fied organisms or This product contains genetically modi-fied name of organism(s)appear on a label;(b)fornon-pre-packagedproductsofferedtothefinalconsumer the words This product contains geneticallymodified organisms or This product contains geneticallymodified name of organism(s)shall appear on,or inconnection with,the display of the product.This paragraph shall be without prejudice to other specificrequirements in Community legislation.C.EXEMPTIONS7.Paragraphs 1 to 6 shall not apply to traces of GMOs inproducts in a proportion no higher than the thresholds estab-lished in accordance with Article 21(2)or(3)of Directive2001/18/EC and in other specific Community legislation,provided that these traces of GMOs are adventitious or techni-cally unavoidable.8.Paragraphs 1 to 6 shall not apply to traces of GMOs inproducts intended for direct use as food,feed or for processingin a proportion no higher than the thresholds established forthose GMOs in accordance with Articles 12,24 or 47 of Regu-lation(EC)No 1829/2003,provided that these traces of GMOsare adventitious or technically unavoidable.18.10.2003L 268/26Official Journal of the European UnionEN(1)Regulation(EC)No 178/2002 of the European Parliament and ofthe Council of 28 January 2002 laying down the general principlesand requirements of food law,establishing the European FoodSafety Authority and laying down procedures in matters of foodsafety(OJ L 31,1.2.2002,p.1).(2)Directive 2000/13/EC of the European Parliament and of theCouncil of 20 March 2000 on the approximation of the laws of theMember States relating to the labelling,presentation and advertisingof foodstuffs(OJ L 109,6.5.2000,p.29).Directive as amended byCommission Directive 2001/101/EC(OJ L 310,28.11.2001,p.19).Article 5Traceability requirements for products for food and feedproduced from GMOs1.When placing products produced from GMOs on themarket,operators shall ensure that the following information istransmitted in writing to the operator receiving the product:(a)an indication of each of the food ingredients which isproduced from GMOs;(b)an indication of each of the feed materials or additiveswhich is produced from GMOs;(c)in the case of products for which no list of ingredientsexists,an indication that the product is produced fromGMOs.2.Without prejudice to Article 6,operators shall have inplace systems and standardised procedures to allow the holdingof the information specified in paragraph 1 and the identifica-tion,for a period of five years from each transaction,of theoperator by whom and to whom the products referred to inparagraph 1 have been made available.3.Paragraphs 1 and 2 shall be without prejudice to otherspecific requirements in Community legislation.4.Paragraphs 1,2 and 3 shall not apply to traces of GMOsin products for food and feed produced from GMOs in aproportion no higher than the thresholds established for thoseGMOs in accordance with Articles 12,24 or 47 of Regulation(EC)No 1829/2003,provided that these traces of GMOs areadventitious or technically unavoidable.Article 6Exemptions1.In cases whereCommunity legislation provides forspecific identification systems,such as lot numbering for pre-packaged products,operators shall not be obliged to hold theinformation specified in Articles 4(1),4(2),4(3)and 5(1),provided that this information and the lot n