PAHs欧盟最新标准版.docx
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PAHs欧盟最新标准版.docx
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PAHs欧盟最新标准版
ProductSafetyCommission(AfPS)GSSpecification
Testingandassessmentofpolycyclicaromatichydrocarbons(PAHs)inthecourseofawardingtheGSmark
-Specificationpursuanttoarticle21
(1)no.3oftheProductSafetyAct(ProdSG)–
AfPSGS2014:
01PAK
Stateofrevision:
August4th,2014
Disclaimer:
Germanistheoriginaltextversion.Incaseofanydoubt,lackofclarityoranyothernonclearinterpretationthecontentoftheoriginalversionisvalid.
Management:
FederalInstituteforOccupationalSafetyandHealth
Friedrich-Henkel-Weg1–25
44149DortmundTelefon:
0231/9071-0Telefax:
0231/9071-2364
TableofContents
Preliminaryobservations3
1Purpose/Intention3
2Basics3
3Procedure3
3.1Riskassessment3
3.2Categorisation4
3.3Testingandassessment6
4Transitionalregulations/periods6
4.1GSmarkcertificates,issuedfromJuly1st,2015onwards6
4.2GSmarkcertificates,issuedbeforeJuly1st,20156
4.3ReissuingofexistingGSmarkcertificates–exemptions6
Annex:
Testinginstructions8
1Aimandpurpose8
2Method8
2.1Briefdescription8
2.2Equipment8
2.3Chemicalsandsolutions8
3Preparationandexecution9
3.1Samplepreparation9
3.2Measuringprocedure10
3.3Specialcharacteristics11
Annex:
Measuringconditionsforgaschromatography(forinformation)12
Testingandassessmentofpolycyclicaromatichydrocarbons(PAHs)inthecourseofawardingtheGSmark
Preliminaryobservations
OnAug.4th2014theProductSafetyCommission(AfPS)hasassignedtherequirementsofPAHtestinginthecourseofGSmarkcertificationasspecificationaccordingtoart.21ProductSafetyAct(ProdSG)para.1no.3.TheimplementationisachievedbymeansofthisPAHdocument.
1.Purpose/Intention
Products(pursuanttotheProductSafetyAct)mustcomplywithlegalrequirementstoavoidhealthrisks,e.g.art.30&31oftheLFBG(Foodstuffs,ConsumerGoodsandFeedstuffsCode–LFGB),theProhibitionofChemicalsOrdinance,andtheart.3oftheProdSG(ProductSafetyAct).Thisdocumentand,inparticular,thetestinginstructions(seeAnnex)specifytherequirementswithrespecttothelevelofPAHsinproducts.Inaddition,thedocumentharmonisesthetestingmethodologyforassessmentbyGSbodies.
2.Basics
PAHcontaminationofmaterialsisprimarilyduetotheuseof:
-PAHcontaminatedsofteningoilsinrubberandflexible(soft)plastics
-PAH-contaminatedcarbonblackasablackpigmentinrubber,plasticsandpaints.
PAHcontaminationhaspreviouslybeendetectednotonlyinrubberbutalsoinvarioustypesofplastic,e.g.ABSandPP,andvariouspaints/coatings,aswellasinavarietyofnaturalmaterials.
3.Procedure
TheGSbodymusttakethefollowingstepsintoaccountbothintheprocessofawardinganewGSmarkandwithintheframeworkofmonitoringexistingGSmarkcertificates:
1.Riskassessment
2.Categorisation
3.Testingandassessment
3.1Riskassessment
TheGSbodymustcarryoutariskassessmentand,indoingso,definewhichrelevantcontact/gripandoperatingsurfacesoftheproductaretobeconsideredfortestingandwhicharenot,andmustmakearecordofthese(thismeansthattheGSbodymustfirstspecifythecontact/gripandoperatingareastowhichtherequirementsofthePAHdocumentmustbeapplied(specificationofPAHrelevance)).Theriskassessmentshouldbenotapplied,whereappropriate,iftherespective“Erfahrungsaustauschkreis”(“ExchangeofExperienceGroup”,EK)hasalreadydefinedaprocedurefortheproductorproductgroupwithregardtothecontact/grip
andoperatingsurfacestobetested.AreferencetotheEK’sdefinitionistobeincludedinthedocumentationaccordingly.
Materialsthatcannotbeaccessedorthatcanonlybeaccessedbyusingtoolsneednotbeassessed,withtheexceptionofsampleswithaconspicuousodour.
Inprinciple,accountmustbetakenofallcontact/gripandoperatingsurfacesthatcancomeintodirectcontactwiththeskinorthatcanbeputintothemouthduringproperorforeseeableuse(butnotmisuse).1
3.2Categorisation
Dependingontheresultsoftheriskassessment,thecorrespondingproductpartsarethentobecategorised(seeTable1)andtobeanalysedontheiractualPAHcontentaccordingtotheanalysismethodbelow.Existingtestreportscanbetakenintoaccountiftheyarecompliantwiththe“Grundsatzbeschluss”(“principledecision”)ZEK-GB-2012-01oftheZEK(“CentralExchangeofExperienceGroup”)andtherequirementsofthisPAHdocument.Categorisationcanbedispensedwithiftherespective”Erfahrungsaustauschkreis”(“ExchangeofExperienceGroup”,EK)hasalreadydefinedacategorisationofthecontact/gripandoperatingsurfacesforaproductorproductgroup.DefinitionsforproductsorproductgroupsfromtheindividualEKsarepublishedontheZLSwebsite2andapplyfromthetimeofpublication.
Table1presentsthemaximumlevelsofPAHinproductmaterials,whichmustnotbeexceeded.TheprovisionsofthisdocumentwithregardtothePAHcontentdonotapplyifotherlegislationlaysdowncorrespondingorfurtherrequirementsforthePAHcontent.Thisappliesonlytothematerialorcomponent/assemblyandnottotheproductasawhole.MaterialsandpartsoftheproductthatarenotcoveredbyotherlegislativeprovisionsmustbeassessedwithintheframeworkoftheprocedureforawardingtheGSmarkinaccordancewiththerequirementsofthePAHdocument.
Itmustbeensuredthatthemethodoftestingcanactuallyachievethelimitofquantificationof
0.2mg/kgforeachindividualPAHcomponent3.
Atthesametime,methodandmatrixeffects,aswellasthemeasurementuncertainty,theefficiencyofextractionandlossesduringpurificationmustbeconsidered.
BasedonthefindingsoftheUnitedStatesEnvironmentalProtectionAgency(EPA)(accordingtothelistintheZEKdocument04-11),thetotalof18PAHs(extendedsubstancelistoftheAtAV,thepredecessorcommitteeoftheAfPS)onlyconsidersPAHcomponentswhoselevelinthematerialisfoundtoexceed0.2mg/kg.
1However,inordertoensureaconsistentandappropriateprocedureduringtheawardingofGSmark,itisnotgenerallynecessarytoanalyseallfreelyaccessiblesurfaces.Itisthisdocument’sintentiontolimittheconsiderationtorelevantcontact/gripandoperatingsurfaces.Itisnotexpedienttotestallproductpartsorsurfacesinorder“tobeonthesafeside”.
2HomepageofZLS(CentralAuthorityoftheLaenderforSafety):
3Example:
Water-carryingpartsincoffeemachinesthatcomeintocontactwithfoodstuffs(e.g.water,etc.)aresubjecttotheFoodandFeedCodelegislationandarethereforeexcludedfromthePAHdocument’sfieldofapplication.However,gripsurfacesonthecoffeemachinemuststillbeassessedaccordingtotherequirementsofthePAHdocument.
Table1:
MaximumPAHlevelstobecompliedwithforthematerialsinrelevantcontact/gripandoperatingsurfacesthataretobecategorisedbasedontheresultsoftheriskassessment.
Parameter
Category1
Category2
Category3
Materialsindentedtobeputinthemouth,
ormaterialsoftoyswithintendedlong-termskincontact(longerthan30s)
Materialsnotcoveredbycategory1,withforeseeableskincontactforlongerthan30seconds(long-termskincontact)orrepeated
short-termskincontact1)
Materialsnotcoveredbycategory1or2withforeseeableskincontactupto30seconds(shorttermskincontact)
Toysinthescopeof2009/48/EC
Otherproductsinthescope
ofProdSG
Toysinthescopeof2009/48/EC
Otherproductsinthescope
ofProdSG
BENZO(a)PYRENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(e)PYREN
Emg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(a)ANTHRACENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(b)FLUORANTHENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(j)FLUORANTHENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(k)FLUORANTHENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
CHRYSEN
Emg/kg
<0.2
<0.2
<0.5
<0.5
<1
DIBENZO(a,h)ANTHRACEN
Emg/kg
<0.2
<0.2
<0.5
<0.5
<1
BENZO(g,h,i)PERYLENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
INDENO(l,2,3-cd)PYRENE
mg/kg
<0.2
<0.2
<0.5
<0.5
<1
ACENAPHTHYLENE,ACENAPHTHENE,FLUORENE,PHENANTHRENE,PYRENE,ANTHRACENE,FLUORANTHENE
mg/kg
<1
sum
<5
sum
<10
sum
<20
sum
<50
sum
NAPHTHALENE
mg/kg
<1
<2
<10
Sum18PAH3mg/kg
<1
<5
<10
<20
<50
*Wording“short-termrepetitiveskincontact”fromsupplementtoREACHannexXVIIno.50(REGULATION(EU)No1272/2013)
3.3Testingandassessment
Thetestinginstructionsfoundintheannexdescribethestepsofsamplepreparation,extractionofthePAHs,purificationoftheextract,identificationandquantification;thesemustbeapplieduniformlybyalllaboratoriescarryingouttesting.
TheGSbodyassessesthetestresultsanddecideswhethertheGSmarkcanbeawardedincompliancewiththeotherrequirements.
4.Transitionalregulations/periods
FromJuly1st2015(issuedateoftheGSmarkcertificate),itiscompulsorytoapplythisdocumentwhenawardingtheGSmarktoproducts.
ThedocumentZEK01.4-08willceasetobevalidfromJune30th2015.
SincetestingforPAHlevelsinproductsconstitutesanoverarchingrequirementforalmostallofthemembersofallofthe”Erfahrungsaustauschkreise”(“ExchangeofExperienceGroups”),thefollowingprocedureisdefined:
4.1GSmarkcertificates,issuedfromJuly1st2015onwards
(incl.ongoingproceduresthatareconcludedafterJuly1st2015)
CompulsoryapplicationofthisGSspecificationfromJuly1st2015onwards(exception:
see4.3).
4.2GSmarkcertificates,issuedbeforeJuly1st2015
ExistingGSmarkcertificatesinitiallyremainvalid.
Withi
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