2011-10-EU 与食品接触的塑料物料和制品

DIRECTIVESCOMMISSIONDIRECTIVE2011/10/EUof8February2011amendingDirective98/8/ECoftheEuropeanParliamentandoftheCounciltoincludebifenthrinasanactivesubstanceinAnnexIthereto(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,HavingregardtoDirective98/8/ECoftheEuropeanParliamentandoftheCouncilof16February1998concerningtheplacingofbiocidalproductsonthemarket(1),andinparticularthesecondsubparagraphofArticle16(2)thereof,Whereas:(1)CommissionRegulation(EC)No1451/2007of4December2007onthesecondphaseofthe10-yearworkprogrammereferredtoinArticle16(2)ofDirective98/8/ECoftheEuropeanParliamentandoftheCouncilconcerningtheplacingofbiocidalproductsonthemarket(2)establishesalistofactivesubstancestobeassessed,withaviewtotheirpossibleinclusioninAnnexI,IAorIBtoDirective98/8/EC.Thatlistincludesbifenthrin.(2)PursuanttoRegulation(EC)No1451/2007,bifenthrinhasbeenevaluatedinaccordancewithArticle11(2)ofDirective98/8/ECforuseinproducttype8,woodpreservatives,asdefinedinAnnexVtothatDirective.(3)FrancewasdesignatedasRapporteurMemberStateandsubmittedthecompetentauthorityreport,togetherwitharecommendation,totheCommissionon3January2008inaccordancewithArticle14(4)and(6)ofRegu­lation(EC)No1451/2007.(4)ThecompetentauthorityreportwasreviewedbytheMemberStatesandtheCommission.InaccordancewithArticle15(4)ofRegulation(EC)No1451/2007,thefindingsofthereviewwereincorporated,withintheStandingCommitteeonBiocidalProductson24September2010,inanassessmentreport.(5)ItappearsfromtheevaluationsthatbiocidalproductsusedaswoodpreservativesandcontainingbifenthrinmaybeexpectedtosatisfytherequirementslaiddowninArticle5ofDirective98/8/EC.Itisthereforeappro­priatetoincludebifenthrininAnnexItothatDirective.(6)NotallpotentialuseshavebeenevaluatedattheUnionlevel.ItisthereforeappropriatethatMemberStatesassessthoseusesorexposurescenariosandthoseriskstoenvi­ronmentalcompartmentsandpopulationsthathavenotbeenrepresentativelyaddressedintheUnionlevelriskassessmentand,whengrantingproductauthorisations,ensurethatappropriatemeasuresaretakenorspecificconditionsimposedinordertoreducetheidentifiedriskstoacceptablelevels.(7)Unacceptableriskswereidentifiedfornon-professionalusers.Itisthereforeappropriatetorequirethatproductauthorisationsarelimitedtoindustrialorprofessionaluse,unlessitisdemonstratedintheapplicationforproductauthorisationthatriskstonon-professionaluserscanbereducedtoacceptablelevelsinaccordancewithArticle5of,andAnnexVIto,Directive98/8/EC.(8)Inviewoftheassumptionsmadeduringtheriskassessment,itisappropriatetorequirethatproductsauthorisedforindustrialorprofessionaluseareusedwithappropriatepersonalprotectiveequipment,unlessitcanbedemonstratedintheapplicationforproductauthorisationthatriskstoindustrialorprofessionaluserscanbereducedtoanacceptablelevelbyothermeans.EN9.2.2011OfficialJournaloftheEuropeanUnionL34/41(1)OJL123,24.4.1998,p.1.(2)OJL325,11.12.2007,p.3.(9)Inviewoftherisksidentifiedforthesoilandaquaticcompartments,appropriatemeasuresshouldbetakentoprotectthosecompartments.Itisthereforeappropriatetorequirethatinstructionsareprovidedtoindicatethatfreshlytreatedtimberisstoredaftertreatmentundershelteroronimpermeablehardstanding,orboth,andthatanylossesfromtheapplicationofproductsusedaswoodpreservativesandcontainingbifenthrinarecollectedforreuseordisposal.Furthermore,itisappro­priatetorequirethatproductsarenotauthorisedfortheinsitutreatmentofwoodoutdoors,orfortreatmentofwoodthatwillbeeithercontinuallyexposedtotheweatherorprotectedfromtheweatherbutsubjecttofrequentwetting(useclass3asdefinedbyOECD(1),unlessdataissubmitteddemonstratingthattheproductwillmeettherequirementsofArticle5of,andAnnexVIto,Directive98/8/EC,ifnecessarybytheapplicationofappropriateriskmitigationmeasures.(10)ItisimportantthattheprovisionsofthisDirectivebeappliedsimultaneouslyinallMemberStatesinordertoensureequaltreatmentofbiocidalproductsonthemarketcontainingtheactivesubstancebifenthrinandalsotofacilitatetheproperoperationofthebiocidalproductsmarketingeneral.(11)AreasonableperiodshouldbeallowedtoelapsebeforeanactivesubstanceisincludedinAnnexItoDirective98/8/ECinordertopermitMemberStatesandinterestedpartiestopreparethemselvestomeetthenewrequirementsentailedandtoensurethatapplicantswhohaveprepareddossierscanbenefitfullyfromthe10-yearperiodofdataprotection,which,inaccordancewithArticle12(1)(c)(ii)ofDirective98/8/EC,startsfromthedateofinclusion.(12)Afterinclusion,MemberStatesshouldbeallowedareasonableperiodtoimplementArticle16(3)ofDirective98/8/EC.(13)Directive98/8/ECshouldthereforebeamendedaccordingly.(14)ThemeasuresprovidedforinthisDirectiveareinaccordancewiththeopinionoftheStandingCommitteeonBiocidalProducts,HASADOPTEDTHISDIRECTIVE:Article1AnnexItoDirective98/8/ECisamendedinaccordancewiththeAnnextothisDirective.Article2Transposition1.MemberStatesshalladoptandpublish,by31January2012atthelatest,thelaws,regulationsandadministrativeprovisionsnecessarytocomplywiththisDirective.Theyshallapplythoseprovisionsfrom1February2013.WhenMemberStatesadoptthoseprovisions,theysha