(EU) No 252-2011 关于评估物质和准备化学品安全报告的一般规定

REGULATIONSCOMMISSIONREGULATION(EU)No252/2011of15March2011amendingRegulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncilontheRegistration,Evaluation,AuthorisationandRestrictionofChemicals(REACH)asregardsAnnexI(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,HavingregardtoRegulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncilof18December2006concerningtheRegistration,Evaluation,AuthorisationandRestrictionofChemicals(REACH),establishingaEuropeanChemicalsAgency,amendingDirective1999/45/ECandrepealingCouncilRegulation(EEC)No793/93andCommissionRegulation(EC)No1488/94aswellasCouncilDirective76/769/EECandCommissionDirectives91/155/EEC,93/67/EEC,93/105/ECand2000/21/EC(1),andinparticularArticle131thereof,Whereas:(1)Regulation(EC)No1272/2008oftheEuropeanParliamentandoftheCouncilof16December2008onclassification,labellingandpackagingofsubstancesandmixtures,amendingandrepealingDirectives67/548/EECand1999/45/EC,andamendingRegulation(EC)No1907/2006(2)harmonisestheprovisionsandcriteriafortheclassificationandlabellingofsubstances,mixturesandcertainspecificarticleswithintheCommunity,takingintoaccounttheclassificationcriteriaandlabellingrulesoftheGloballyHarmonisedSystemofClassificationandLabellingofChemicals.(2)CouncilDirective67/548/EECof27June1967ontheapproximationofthelaws,regulationsandadministrativeprovisionsrelatingtotheclassification,packagingandlabellingofdangeroussubstances(3)andDirective1999/45/ECoftheEuropeanParliamentandoftheCouncilof31May1999concerningtheapproximationofthelaws,regulationsandadministrativeprovisionsoftheMemberStatesrelatingtotheclassification,packagingandlabellingofdangerouspreparations(4)wereamendedseveraltimes.Directives67/548/EECand1999/45/ECwillbereplacedoveratransitionalperiodaccordingtowhichsubstancesmustbeclassified,labelledandpackagedaccordingtoRegulation(EC)No1272/2008from1December2010andmixturesfrom1June2015,althoughfrom1December2010until1June2015classificationofsubstancesaccordingtobothDirective67/548/EECandRegulation(EC)No1272/2008isrequired.BothDirectiveswillberepealedinfullbyRegulation(EC)No1272/2008witheffectfrom1June2015.(3)AnnexItoRegulation(EC)No1907/2006shouldbeamendedtoadaptittothecriteriaforclassificationandotherrelevantprovisionslaiddowninRegulation(EC)No1272/2008.(4)Article58(1)ofRegulation(EC)No1272/2008modifiesArticle14(4)ofRegulation(EC)No1907/2006toadaptittotheclassificationcriteriainRegulation(EC)No1272/2008.ThisalsohasconsequencesforAnnexItoRegulation(EC)No1907/2006,whichwasnotamendedbyRegulation(EC)No1272/2008.ItisthereforenecessarytoadaptAnnexItoRegulation(EC)No1907/2006tothenewtextinitsArticle14(4).(5)Regulation(EC)No1272/2008introducessubstantivechangesinterminologycomparedtothoseusedinDirective67/548/EEC.AnnexItoRegulation(EC)No1907/2006wasnotamendedbyRegulation(EC)No1272/2008andshouldbeupdatedtoreflectthesechangesandensureconsistencythroughout.(6)Furthermore,referencestoDirective67/548/EECshouldbereplacedbyappropriatereferencestoRegulation(EC)No1272/2008.EN16.3.2011OfficialJournaloftheEuropeanUnionL69/3(1)OJL396,30.12.2006,p.1.(2)OJL353,31.12.2008,p.1.(3)OJ196,16.8.1967,p.1.(4)OJL200,30.7.1999,p.1.(7)InaccordancewithRegulation(EC)No1907/2006,registrationsincludingchemicalsafetyreportswillhavebeensubmittedbythedateofapplicationofthisRegu­lation.ChangesinclassificationcriteriaandotherrelevantprovisionsresultingfromRegulation(EC)No1272/2008applytosubstancesfrom1December2010,inaccordancewiththesecondparagraphofArticle62ofthatRegulation.Inordertoensureasmoothtransitionfortheupdatingofregistrations,atransitionalperiodshouldbeprovided.(8)AnnexItoRegulation(EC)No1907/2006shouldthereforebeamendedaccordingly.(9)ThemeasuresprovidedforinthisRegulationareinaccordancewiththeopinionoftheCommitteeestab­lishedpursuanttoArticle133ofRegulation(EC)No1907/2006,HASADOPTEDTHISREGULATION:Article1AnnexItoRegulation(EC)No1907/2006isamendedasfollows:1.point0.6isreplacedbythefollowing:‘0.6.Stepsofachemicalsafetyassessment0.6.1.Achemicalsafetyassessmentperformedbyamanu­factureroranimporterforasubstanceshallincludethefollowingsteps1to4inaccordancewiththerespectivesectionsofthisAnnex:1.Humanhealthhazardassessment.2.Humanhealthhazardassessmentofphysico­chemicalproperties.3.Environmentalhazardassessment.4.PBTandvPvBassessment.0.6.2.Inthecasesreferredtoinpoint0.6.3thechemicalsafetyassessmentshallalsoincludethefollowingsteps5and6inaccordancewithSections5and6ofthisAnnex:5.Exposureassessment.5.1.Thegenerationofexposurescenario(s)(ortheidentificationofrelevantuseandexposurecategories,ifappropriate).5.2.Exposureestimation.6.Riskcharacterisation.0.6.3.Whereasaresultofsteps1to4themanufacturerorimporterconcludesthatthesubstancefulfilsthecriteriaforanyofthefollowinghazardclassesorcategoriessetoutinAnnexItoRegulation(EC)No1272/2008orisassessedtobeaPBTorvPvB,thechemicalsafetyassessmentshallalsoincludesteps5and6inaccordancewithSections5and6ofthisAnnex:(a)hazardclasses2.1to2.4,2.6and2.7,2.8typesAandB,2.9,2.10,2.12,2.13categories1and2,2.14c