200719EC

DIRECTIVESCOMMISSIONDIRECTIVE2007/19/ECof30March2007amendingDirective2002/72/ECrelatingtoplasticmaterialsandarticlesintendedtocomeintocontactwithfoodandCouncilDirective85/572/EEClayingdownthelistofsimulantstobeusedfortestingmigrationofconstituentsofplasticmaterialsandarticlesintendedtocomeintocontactwithfoodstuffs(TextwithEEArelevance)THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,HavingregardtotheTreatyestablishingtheEuropeanCommunity,HavingregardtoRegulation(EC)No1935/2004oftheEuropeanParliamentandoftheCouncilof27October2004onmaterialsandarticlesintendedtocomeintocontactwithfoodandrepealingDirectives80/590/EECand89/109/EEC(1),andinparticularArticle5(2)thereof,AfterconsultingtheEuropeanFoodSafetyAuthority(theAuthority),Whereas:(1)CommissionDirective2002/72/EC(2)isaspecificDirectivewithinthemeaningoftheframeworkRegu-lation(EC)No1935/2004,harmonisingtherulesfortheplasticsmaterialsandarticlesintendedtocomeintocontactwithfood.(2)Directive2002/72/ECestablishesalistofauthorisedsubstancesforthemanufactureofthosematerialsandarticles,inparticularadditivesandmonomers,therestrictionsontheiruse,rulesonlabellingaswellastheinformationtobegiventoconsumersortofoodbusinessoperatorsconcerningcorrectuseofthosematerialsandarticles.(3)InformationprovidedtotheCommissiondemonstratesthattheplasticizersusede.g.inpolyvinylchloride(PVC)gasketsinlidsmaymigrateintofattyfoodsinquantitiesthatcouldendangerhumanhealthorbringaboutanunacceptablechangeinthecompositionofthefoods.Itshouldthereforebemadeclearthat,eveniftheyarepartofe.g.metallids,gasketsfallunderthescopeofDirective2002/72/EC.Atthesametime,specificrulesshouldbelaiddownasregardtheuseofadditivesforthemanufactureofthosegaskets.ItisappropriatetotakeaccountoftheneedoflidmanufacturerstohavesufficienttimetoadapttosomeoftheprovisionsofDirective2002/72/EC.Inparticular,takingintoaccountthetimeneededtoprepareanapplicationfortheevaluationofspecificadditivesusedforthemanufactureofgasketsoflids,itisnotyetpossibletoestablishatimetablefortheirevaluation.Therefore,inafirststage,thepositivelistofauthorisedadditivesthatwillbeadoptedinthefutureforplasticmaterialsandarticlesshouldnotapplyforthemanufactureofgasketsinlids,sothattheuseofotheradditiveswillremainpossible,subjecttonationallaw.Thissituationshouldbereassessedatalaterstage.(4)OnthebasisofnewinformationrelatedtotheriskassessmentofsubstancesevaluatedbytheAuthorityandtheneedtoadapttotechnicalprogresstheexistingrulesforcalculatingmigration,Directive2002/72/ECshouldbeupdated.Forreasonsofclaritydefinitionsoftechnicaltermsusedshouldbeintroduced.(5)Therulesforoverallmigrationandspecificmigrationshouldbebasedonthesameprincipleandshouldtherefore,bealigned.(6)Specificrulesshouldbeintroducedtoimprovetheprotectionofinfants,sinceinfantsingestmorefoodinproportiontotheirbodyweightthanadults.(7)Theverificationofcompliancewiththespecificmigrationlimits(SML)insimulantDforadditiveslistedinAnnexIII,SectionB,toDirective2002/72/ECshouldbeappliedatthesametimeastheotherprovisionsforcalculatingmigrationintroducedinthisDirectiveforbetterestimationoftherealexposureoftheconsumertothoseadditives.Therefore,thedeadlineforapplicationoftheabovementionedverificationofcomplianceshouldbeextended.EN31.3.2007OfficialJournaloftheEuropeanUnionL91/17(1)OJL338,13.11.2004,p.4.(2)OJL220,15.8.2002,p.18.DirectiveaslastamendedbyDirective2005/79/EC(OJL302,19.11.2005,p.35).(8)Thestatusofadditivesactingaspolymerisationproductionaids(PPA)shouldbeclarified.ThePPAwhichalsofunctionasadditivesaretobeevaluatedandincludedinthefuturepositivelistofadditives.Someofthemarealreadyincludedinthecurrentincompletelistofadditives.AsregardsadditiveswhichexclusivelyactasPPAandarethereforenotintendedtoremaininthefinishedarticle,itshouldbemadeclearthattheirusewillremainpossible,subjecttonationallaw,evenaftertheadoptionofthefuturepositivelistofadditives.Thatsituationshouldbereassessedatalaterstage.(9)Studieshaveshownthatazodicarbonamidedecomposesintosemicarbazideduringhightemperatureprocessing.In2003theAuthoritywasaskedtogatherdataandtoassessthepossiblerisksposedbysemicarbazideinfood.UntilthatinformationwasobtainedandinaccordancetoArticle7ofRegulation(EC)No178/2002oftheEuropeanParliamentandoftheCouncilof28January2002layingdownthegeneralprinciplesandrequirementsoffoodlaw,establishingtheEuropeanFoodSafetyAuthorityandlayingdownproceduresinmattersoffoodsafety(1),theuseofazodicarbonamideinplasticmaterialsandarticleswassuspendedbyCommissionDirective2004/1/EC(2).Initsopinionof21June2005,theAuthority(3)concludedthatcarcino-genicityofsemicarbazideisnotofconcernforhumanhealthattheconcentrationsencounteredinfood,ifthesourceofsemicarbaziderelatedtoazodicarbonamideiseliminated.Thereforeitisappropriatetomaintaintheprohibitionofuseofazodicarbonamideinplasticmaterialsandarticle.(10)Theconceptoftheplasticfunctionalbarrier,thatisabarrierwithinplasticmaterialsorarticlespreventingorreducingthemigrationfrombehindthisbarrierintothefoodshouldbeintroduced.Onlyglassandsomemetalsmayensurecompleteblockageofmigration.Plasticsmaybepartialfunctionalbar