(EU)2015-863

DIRECTIVESCOMMISSIONDELEGATEDDIRECTIVE(EU)2015/863of31March2015amendingAnnexIItoDirective2011/65/EUoftheEuropeanParliamentandoftheCouncilasregardsthelistofrestrictedsubstances(TextwithEEArelevance)THEEUROPEANCOMMISSION,HavingregardtotheTreatyontheFunctioningoftheEuropeanUnion,HavingregardtoDirective2011/65/EUoftheEuropeanParliamentandoftheCouncilof8June2011ontherestrictionoftheuseofcertainhazardoussubstancesinelectricalandelectronicequipment,(1)andinparticularArticle6(3)thereof,Whereas:(1)Directive2011/65/EUlaysdownrulesontherestrictionoftheuseofhazardoussubstancesinelectricalandelectronicequipment(EEE)withaviewtocontributingtotheprotectionofhumanhealthandtheenvironment,includingtheenvironmentallysoundrecoveryanddisposalofwasteEEE.(2)Directive2011/65/EUprohibitstheuseoflead,mercury,cadmium,hexavalentchromium,polybrominatedbiphenyls(PBB)andpolybrominateddiphenylethers(PBDE)inelectricalandelectronicequipmentplacedontheUnionmarket.AnnexIItothatDirectiveliststhoserestrictedsubstances.(3)TheriskstohumanhealthandtheenvironmentarisingfromtheuseofHexabromocyclododecane(HBCDD),Bis(2-ethylhexyl)phthalate(DEHP),Butylbenzylphthalate(BBP)andDibutylphthalate(DBP)shouldbeconsideredapriorityintheperiodicreviewofthelistofrestrictedsubstancesinAnnexII.Withaviewtofurtherrestrictions,thesubstancesthatweresubjecttopreviousassessmentsshouldbere-investigated.(4)InaccordancewithArticle6(1)ofDirective2011/65/EU,interestedparties,includingeconomicoperators,recyclers,treatmentoperators,environmentalorganisationsandemployeeandconsumerassociations,havebeenconsultedandathoroughassessmenthasbeenperformed.(5)Bis(2-ethylhexyl)phthalate(DEHP),Butylbenzylphthalate(BBP),Dibutylphthalate(DBP)andDiisobutylphthalate(DIBP)aresubstancesofveryhighconcern(SVHC).DIBPisasubstancethatcanbeusedasasubstituteforDBPandwassubjecttopreviousassessmentsperformedbytheCommission.Theavailableevidenceindicatesthatthosefoursubstances,whenusedinEEE,canhaveanegativeimpactonrecyclingandonhumanhealthandtheenvironmentduringEEEwastemanagementoperations.(6)SubstitutesthathavelessnegativeimpactsareavailableforDEHP,BBP,DBPandDIBPinmostEEE.TheuseofthosesubstancesinEEEshouldthereforeberestricted.DEHP,BBPandDBParealreadyrestrictedthroughentry51ofAnnexXVIItoRegulation(EC)No1907/2006oftheEuropeanParliamentandoftheCouncil,(2)sothattoyscontainingDEHP,BBPorDBPinaconcentrationgreaterthan0,1%byweightoftheplasticisedmaterial,calculatedforthethreephthalatescumulatively,cannotbeplacedontheEUmarket.Inordertoavoiddoubleregulation,therestrictionthroughentry51ofAnnexXVIItothatRegulationshallthereforecontinuetobetheonlyrestrictionapplicabletoDEHP,BBPandDBPintoys.4.6.2015L137/10OfficialJournaloftheEuropeanUnionEN(1)OJL174,1.7.2011,p.88.(2)Regulation(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(OJL396,30.12.2006,p.1).(7)Inordertofacilitatetransitionandtomitigatepossiblesocioeconomicimpacts,anappropriatetransitionperiodshouldbegranted,whichwillalloweconomicoperatorstoapplyforexemptionsfromthesubstancerestrictionsinaccordancewithArticle5ofDirective2011/65/EU.Thelongerinnovationcyclesformedicaldevicesandmonitoringandcontrolinstrumentsshouldbetakenintoaccountwhiledeterminingthetransitionalperiod.TherestrictionoftheuseofDEHP,BBP,DBPandDIBPshouldthereforeapplytomedicaldevices,includinginvitromedicaldevices,andmonitoringandcontrolinstruments,includingindustrialmonitoringandcontrolinstruments,from22July2021.(8)AnyadaptationofAnnexIIIorIVtoDirective2011/65/EUtoexemptapplicationsinrelationtoDEHPorDBPshouldtakeplaceinamannerwhich,inordertoavoiddoubleregulationandunnecessaryburden,ensurescoherencewiththeadministrationofanyauthorisationgrantedunderRegulation(EC)No1907/2006inrelationtotheincorporationofthosesubstancesinEEE.OperatorsconsideringwhethertoapplyforexemptionsunderDirective2011/65/EUshouldbeawarethatsuchexemptionsmaycovertheentirelifecycleoftheEEE,includingthemanufacturingphase.(9)Directive2011/65/EUshouldthereforebeamendedaccordingly,HASADOPTEDTHISDIRECTIVE:Article1AnnexIItoDirective2011/65/EUisreplacedbythetextintheAnnextothisDirective.Article21.MemberStatesshalladoptandpublish,by31December2016atthelatest,thelaws,regulationsandadminis­trativeprovisionsnecessarytocomplywiththisDirective.TheyshallforthwithcommunicatetotheCommissionthetextofthoseprovisions.Theyshallapplythoseprovisionsfrom22July2019.WhenMemberStatesadoptthoseprovisions,theyshallcontainareferencetothisDirectiveorbeaccompaniedbysuchareferenceontheoccasionoftheirofficialpublication.MemberStatesshalldeterminehowsuchreferenceistobemade.2.MemberStatesshallcommunicatetotheCommissionthetextofthemainprovisionsofnationallawwhichtheyadoptinthefieldcoveredbythisDirective.Article3ThisDirectiveshallente