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首页 欧洲塑料标准

欧洲塑料标准.pdf

欧洲塑料标准

bluewindlixing
2011-02-08 0人阅读 举报 0 0 暂无简介

简介:本文档为《欧洲塑料标准pdf》,可适用于工程科技领域

ENENEUROPEANCOMMISSIONBrussels,C()finalDraftCOMMISSIONREGULATIONofonplasticmaterialsandarticlesintendedtocomeintocontactwithfood(TextwithEEArelevance)ENENDraftCOMMISSIONREGULATIONofonplasticmaterialsandarticlesintendedtocomeintocontactwithfood(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,HavingregardtoRegulation(EC)NooftheEuropeanParliamentandoftheCouncilofOctoberonmaterialsandarticlesintendedtocomeintocontactwithfoodandrepealingDirectivesEECandEEC,andinparticularArticle()(a),(c),(d),(e),(f),(h),(i)and(j)thereof,AfterconsultingtheEuropeanFoodSafetyAuthority,Whereas:()Regulation(EC)NolaysdownthegeneralprinciplesforeliminatingthedifferencesbetweenthelawsoftheMemberStatesasregardsfoodcontactmaterialsArticle()ofthatRegulationprovidesfortheadoptionofspecificmeasuresforgroupsofmaterialsandarticlesanddescribesindetailtheprocedurefortheauthorisationofsubstancesatEUlevelwhenaspecificmeasureprovidesforalistofauthorisedsubstances()ThisRegulationisaspecificmeasurewithinthemeaningofArticle()ofRegulation(EC)NoThisRegulationshouldestablishthespecificrulesforplasticmaterialsandarticlestobeappliedfortheirsafeuseandrepealCommissionDirectiveECofAugustonplasticmaterialsandarticlesintendedtocomeintocontactwithfoodstuffs()DirectiveECsetsoutbasicrulesforthemanufactureofplasticmaterialsandarticlesTheDirectivehasbeensubstantiallyamendedtimesForreasonsofclaritythetextshouldbeconsolidatedandredundantandobsoletepartsremoved()InthepastDirectiveECanditsamendmentshavebeentransposedintonationallegislationwithoutanymajoradaptationFortranspositionintonationallawusuallyatimeperiodofmonthsisnecessaryIncaseofamendingthelistsofmonomersandadditivesinordertoauthorisenewsubstancesthistranspositiontimeOJL,,pOJL,,pENENleadstoaretardationoftheauthorisationandthusslowsdowninnovationThereforeitseemsappropriatetoadoptrulesonplasticmaterialsandarticlesinformofaRegulationdirectlyapplicableinallMemberStates()DirectiveECappliestomaterialsandarticlespurelymadeofplasticsandtoplasticgasketsinlidsInthepastthesewerethemainuseofplasticsonthemarketHowever,inrecentyears,besidesmaterialsandarticlespurelymadeofplastics,plasticsarealsousedincombinationwithothermaterialsinsocalledmultimaterialmultilayersRulesontheuseofvinylchloridemonomerlaiddowninCouncilDirectiveEECofJanuaryontheapproximationofthelawsoftheMemberStatesrelatingtomaterialsandarticleswhichcontainvinylchloridemonomerandareintendedtocomeintocontactwithfoodstuffsalreadyapplytoallplasticsThereforeitseemsappropriatetoextendthescopeofthisRegulationtoplasticlayersinmultimaterialmultilayers()PlasticmaterialsandarticlesmaybecomposedofdifferentlayersofplasticsheldtogetherbyadhesivesPlasticmaterialsandarticlesmayalsobeprintedorcoatedwithanorganicorinorganiccoatingPrintedorcoatedplasticmaterialsandarticlesaswellasthoseheldtogetherbyadhesivesshouldbewithinthescopeoftheRegulationAdhesives,coatingsandprintinginksarenotnecessarilycomposedofthesamesubstancesasplasticsRegulation(EC)Noforeseesthatforadhesives,coatingsandprintinginksspecificmeasurescanbeadoptedThereforeplasticmaterialsandarticlesthatareprinted,coatedorheldtogetherbyadhesivesshouldbeallowedtocontainintheprinting,coatingoradhesivelayerothersubstancesthanthoseauthorisedatEUlevelforplasticsThoselayersmaybesubjecttootherEUornationalrules()Plasticsaswellasionexchangeresins,rubbersandsiliconesaremacromolecularsubstancesobtainedbypolymerisationprocessesRegulation(EC)Noforeseesthatforionexchangeresins,rubbersandsiliconesspecificmeasurescanbeadoptedAsthosematerialsarecomposedofdifferentsubstancesthanplasticsandhavedifferentphysicochemicalpropertiesspecificrulesforthemneedtoapplyanditshouldbemadeclearthattheyarenotwithinthescopeofthisRegulation()Plasticsaremadeofmonomersandotherstartingsubstanceswhicharechemicallyreactedtoamacromolecularstructure,thepolymer,whichformsthemainstructuralcomponentoftheplasticsTothepolymeradditivesareaddedtoachievedefinedtechnologicaleffectsThepolymerassuchisaninerthighmolecularweightstructureAssubstanceswithamolecularweightaboveDausuallycannotbeabsorbedinthebodythepotentialhealthriskfromthepolymeritselfisminimalPotentialhealthriskmayoccurfromnonorincompletelyreactedmonomersorotherstartingsubstancesorfromlowmolecularweightadditiveswhicharetransferredintofoodviamigrationfromtheplasticfoodcontactmaterialThereforemonomers,otherstartingsubstancesandadditivesshouldberiskassessedandauthorisedbeforetheiruseinthemanufactureofplasticmaterialsandarticles()TheriskassessmentofasubstancetobeperformedbytheEuropeanFoodSafetyAuthority(hereinafter"theAuthority")shouldcoverthesubstanceitself,relevantOJL,,pENENimpuritiesandforeseeablereactionanddegradationproductsintheintendeduseTheriskassessmentshouldcoverthepotentialmigrationunderworstforeseeableconditionsofuseandthetoxicityBasedontheriskassessmenttheauthorisationshouldifnecessarysetoutspecificationsforthesubstanceandrestrictionsofuse,quantitativerestrictionsormigrationlimitstoensurethesafetyofthefinalmaterialorarticle()NoruleshaveyetbeensetoutatEUlevelfortheriskassessmentanduseofcolorantsinplasticsThereforetheiruseshouldremainsubjecttonationallawThatsituationshouldbereassessedatalaterstage()SolventsusedinthemanufactureofplasticstocreateasuitablereactionenvironmentareexpectedtoberemovedinthemanufacturingprocessastheyareusuallyvolatileNoruleshaveyetbeensetoutatEUlevelfortheriskassessmentanduseofsolventsinthemanufactureofplasticsThereforetheiruseshouldremainsubjecttonationallawThatsituationshouldbereassessedatalaterstage()PlasticscanalsobemadeofsyntheticornaturaloccurringmacromolecularstructureswhicharechemicallyreactedwithotherstartingsubstancestocreateamodifiedmacromoleculeSyntheticmacromoleculesusedareoftenintermediatestructureswhicharenotfullypolymerisedPotentialhealthriskmayoccurfromthemigrationofnonorincompletelyreactedotherstartingsubstancesusedtomodifythemacromoleculeoranincompletelyreactedmacromoleculeThereforetheotherstartingsubstancesaswellasthemacromoleculesusedinthemanufactureofmodifiedmacromoleculesshouldberiskassessedandauthorisedbeforetheiruseinthemanufactureofplasticmaterialsandarticles()PlasticscanalsobemadebymicroorganismsthatcreatemacromolecularstructuresoutofstartingsubstancesbyfermentationprocessesThemacromoleculeistheneitherreleasedtoamediumorextractedPotentialhealthriskmayoccurfromthemigrationofnonorincompletelyreactedstartingsubstances,intermediatesorbyproductsofthefermentationprocessInthiscasethefinalproductshouldberiskassessedandauthorisedbeforeitsuseinthemanufactureofplasticmaterialsandarticles()DirectiveECcontainsdifferentlistsformonomersorotherstartingsubstancesandforadditivesauthorisedforthemanufactureofplasticmaterialsandarticlesFormonomers,otherstartingsubstancesandadditivestheUnionlistisnowcomplete,thismeansthatonlysubstancesauthorisedatEUlevelmaybeusedThereforeaseparationofmonomersorotherstartingsubstancesandofadditivesinseparatelistsduetotheirauthorisationstatusisnolongernecessaryAscertainsubstancescanbeusedbothasmonomerorotherstartingsubstancesandasadditiveforreasonsofclaritytheyshouldbepublishedinonelistofauthorisedsubstancesindicatingtheauthorisedfunction()PolymerscannotonlybeusedasmainstructuralcomponentofplasticsbutalsoasadditivesachievingdefinedtechnologicaleffectsintheplasticIfsuchapolymericadditiveisidenticaltoapolymerthatcanformthemainstructuralcomponentofaplasticmaterialtheriskfrompolymericadditivecanberegardedasevaluatedifthemonomershavealreadybeenevaluatedandauthorisedInsuchacaseitshouldnotbenecessarytoauthorisethepolymericadditivebutitcouldbeusedonthebasisoftheauthorisationofitsmonomersandotherstartingsubstancesIfsuchapolymericENENadditiveisnotidenticaltoapolymerthatcanformthemainstructuralcomponentofaplasticmaterialthentheriskofthepolymericadditivecannotberegardedasevaluatedbyevaluationofthemonomersInsuchacasethepolymericadditiveshouldberiskassessedasregardsitslowmolecularweightfractionbelowDaandauthorisedbeforeitsuseinthemanufactureofplasticmaterialsandarticles()Inthepastnocleardifferentiationhasbeenmadebetweenadditivesthathaveafunctioninthefinalpolymerandpolymerproductionaids(PPA)thatonlyexhibitafunctioninthemanufacturingprocessandarenotintendedtobepresentinthefinalarticleSomesubstancesactingasPPAhadalreadybeenincludedintheincompletelistofadditivesinthepastThesePPAshouldremainintheUnionlistofauthorisedsubstancesHowever,itshouldbemadeclearthattheuseofotherPPAwillremainpossible,subjecttonationallawThatsituationshouldbereassessedatalaterstage()TheUnionlistcontainssubstancesauthorisedtobeusedinthemanufactureofplasticsSubstancessuchasacids,alcoholsandphenolscanalsooccurinformofsaltsAsthesaltsusuallyaretransformedinthestomachtoacid,alcoholorphenoltheuseofsaltswithcationsthathaveundergoneasafetyevaluationshouldinprinciplebeauthorisedtogetherwiththeacid,alcoholorphenolIncertaincases,wherethesafetyassessmentindicatesconcernsontheuseofthefreeacids,onlythesaltsshouldbeauthorisedbyindicatinginthelistthenameas'acid(s),salts'()SubstancesusedinthemanufactureofplasticmaterialsorarticlesmaycontainimpuritiesoriginatingfromtheirmanufacturingorextractionprocessTheseimpuritiesarenonintentionallyaddedtogetherwiththesubstanceinthemanufactureoftheplasticmaterial(nonintentionallyaddedsubstance–NIAS)AsfarastheyarerelevantfortheriskassessmentthemainimpuritiesofasubstanceshouldbeconsideredandifnecessarybeincludedinthespecificationsofasubstanceHoweveritisnotpossibletolistandconsiderallimpuritiesintheauthorisationThereforetheymaybepresentinthematerialorarticlebutnotincludedintheUnionlist()Inthemanufactureofpolymerssubstancesareusedtoinitiatethepolymerisationreactionsuchascatalystsandtocontrolthepolymerisationreactionsuchaschaintransfer,chainextendingorchainstopreagentsTheseaidstopolymerisationareusedinminuteamountsandarenotintendedtoremaininthefinalpolymerThereforetheyshouldatthispointoftimenotbesubjecttotheauthorisationprocedureatEUlevelAnypotentialhealthriskinthefinalmaterialorarticlearisingfromtheiruseshouldbeassessedbythemanufacturerinaccordancewithinternationallyrecognizedscientificprinciplesonriskassessment()DuringthemanufactureanduseofplasticmaterialsandarticlesreactionanddegradationproductscanbeformedThesereactionanddegradationproductsarenonintentionallypresentintheplasticmaterial(NIAS)AsfarastheyarerelevantfortheriskassessmentthemainreactionanddegradationproductsoftheintendedapplicationofasubstanceshouldbeconsideredandincludedintherestrictionsofthesubstanceHoweveritisnotpossibletolistandconsiderallreactionanddegradationproductsintheauthorisationThereforetheyshouldnotbelistedassingleentriesintheUnionlistAnypotentialhealthriskinthefinalmaterialorarticlearisingfromreactionanddegradationproductsshouldbeassessedbythemanufacturerinaccordancewithinternationallyrecognizedscientificprinciplesonriskassessmentENEN()PriortotheestablishmentoftheUnionlistofadditives,otheradditivesthanthoseauthorisedatEUlevelcouldbeusedinthemanufactureofplasticsForthoseadditiveswhichwerepermittedintheMemberStates,thetimelimitforthesubmissionofdatafortheirsafetyevaluationbytheAuthoritywithaviewtotheirinclusionintheUnionlistexpiredonDecemberAdditivesforwhichavalidapplicationwassubmittedwithinthistimelimitwerelistedinaprovisionallistForcertainadditivesontheprovisionallistadecisionontheirauthorisationatEUlevelhasnotyetbeentakenForthoseadditives,itshouldbepossibletocontinuetobeusedinaccordancewithnationallawuntiltheirevaluationiscompletedandadecisionistakenontheirinclusionintheUnionlist()WhenanadditiveincludedintheprovisionallistisinsertedintheUnionlistorwhenitisdecidednottoincludeitintheUnionlist,thatadditiveshouldberemovedfromtheprovisionallistofadditives()Newtechnologiesengineersubstancesinparticlesizethatexhibitchemicalandphysicalpropertiesthatsignificantlydifferfromthoseatalargerscale,forexample,nanoparticlesThesedifferentpropertiesmayleadtodifferenttoxicologicalpropertiesandthereforethesesubstancesshouldbeassessedonacasebycasebasisbytheAuthorityasregardstheirriskuntilmoreinformationisknownaboutsuchnewtechnologyThereforeitshouldbemadeclearthatauthorisationswhicharebasedontheriskassessmentoftheconventionalparticlesizeofasubstancedonotcoverengineerednanoparticles()BasedontheriskassessmenttheauthorisationshouldifnecessarysetoutspecificmigrationlimitstoensurethesafetyofthefinalmaterialorarticleIfanadditivethatisauthorisedforthemanufactureofplasticmaterialsandarticlesisatthesametimeauthorisedasfoodadditiveorflavouringsubstanceitshouldbeensuredthatthereleaseofthesubstancedoesnotchangethecompositionofthefoodinanunacceptablewayThereforethereleaseofsuchadualuseadditiveorflavouringshouldnotexhibitatechnologicalfunctiononthefoodunlesssuchafunctionisintendedandthefoodcontactmaterialcomplieswiththerequirementsonactivefoodcontactmaterialssetoutinRegulation(EC)NoandCommissionRegulation(EC)NoofMayonactiveandintelligentmaterialsandarticlesintendedtocomeintocontactwithfoodTherequirementsofRegulations(EC)NooftheEuropeanParliamentandoftheCouncilofDecemberonfoodadditivesor(EC)NooftheEuropeanParliamentandoftheCouncilofDecemberonflavouringsandcertainfoodingredientswithflavouringpropertiesforuseinandonfoodsandamendingCouncilRegulation(EEC)No,Regulations(EC)Noand(EC)NoandDirectiveECshouldberespectedwhereapplicable()Accordingtopoint(b)ofArticle()ofRegulation(EC)NothereleaseofsubstancesfromfoodcontactmaterialsandarticlesshouldnotbringaboutunacceptablechangesinthecompositionofthefoodAccordingtogoodmanufacturingpracticeitisfeasibletomanufactureplasticmaterialsinsuchawaythatOJL,,pOJL,,pOJL,,pENENtheyarenotreleasingmorethanmgofsubstancesperdmofsurfaceareaoftheplasticmaterialIftheriskassessmentofanindividualsubstanceisnotindicatingalowerlevel,thislevelshouldbesetasagenericlimitfortheinertnessofaplasticmaterial,theoverallmigrationlimitInordertoachievecomparableresultsintheverificationofcompliancewiththeoverallmigrationlimit,testingshouldbeperformedunderstandardisedtestconditionsincludingtestingtime,temperatureandtestmedium(foodsimulant)representingworstforeseeableconditionsofuseoftheplasticmaterialorarticle()TheoverallmigrationlimitofmgperdmresultsforacubicpackagingcontainingkgoffoodtoamigrationofmgperkgfoodForsmallpackagingwherethesurfacetovolumeratioishighertheresultingmigrationintofoodishigherForinfantsandsmallchildrenwhichhaveahigherconsumptionoffoodperkilogrambodyweightthanadultsanddonotyethaveadiversifiednutrition,specialprovisionsshouldbesetinordertolimittheintakeofsubstancesmigratingfromfoodcontactmaterialsInordertoallowalsoforsmallvolumepackagingthesameprotectionasforhighvolumepackaging,theoverallmigrationlimitforfoodcontactmaterialsthatarededicatedforpackagingfoodsforinfantsandsmallchildrenshouldbelinkedtothelimitinfoodandnottothesurfaceareaofthepackaging()Inrecentyearsplasticfoodcontactmaterialsarebeingdevelopedthatdonotonlyconsistofoneplasticbutcombineuptodifferentplasticlayerstoattainoptimumfunctionalityandprotectionofthefood,whilereducingpackagingwasteInsuchaplasticmultilayermaterialorarticle,layersmaybeseparatedfromthefoodbyafunctionalbarrierThisbarrierisalayerwithinfoodcontactmaterialsorarticlespreventingthemigrationofsubstancesfrombehindthatbarrierintothefoodBehindafunctionalbarrier,nonauthorisedsubstancesmaybeused,providedtheyfulfilcertaincriteriaandtheirmigrationremainsbelowagivendetectionlimitTakingintoaccountfoodsforinfantsandotherparticularlysusceptiblepersons,aswellasthelargeanalyticaltoleranceofthemigrationanalysis,amaximumlevelof,mgkginfoodshouldbeestablishedforthemigrationofanonauthorisedsubstancethroughafunctionalbarrierSubstancesthataremutagenic,carcinogenicortoxictoreproductionshouldnotbeusedinfoodcontactmaterialsorarticleswithoutpreviousauthorisationandshouldthereforenotbecoveredbythefunctionalbarrierconceptNewtechnologiesthatengineersubstancesinparticlesizethatexhibitchemicalandphysicalpropertiesthatsignificantlydifferfromthoseatalargerscale,forexample,nanoparticles,shouldbeassessedonacasebycasebasisasregardstheirriskuntilmoreinformationisknownaboutsuchnewtechnologyTherefore,theysh

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