PAHs欧盟最新标准版62.docx

PAHs欧盟最新标准版62.docx

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PAHs欧盟最新标准版62

ProductSafetyCommission（AfPS）GSSpecification

Testingandassessmentofpolycyclicaromatichydrocarbons（PAHs）inthecourseofawardingtheGSmark

-Specificationpursuanttoarticle21

（1）no.3oftheProductSafetyAct（ProdSG）–

AfPSGS2021:

01PAK

Stateofrevision:

August4th,2021

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,2021onwards6

4.2GSmarkcertificates,issuedbeforeJuly1st,20216

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.4th2021theProductSafetyCommission（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-2021-01oftheZEK（“CentralExchangeofExperienceGroup〞）andtherequirementsofthisPAHdocument.Categorisationcanbedispensedwithiftherespective〞Erfahrungsaustauschkreis〞（“ExchangeofExperienceGroup〞,EK）hasalreadydefinedacategorisationofthecontact/gripandoperatingsurfacesforaproductorproductgroup.DefinitionsforproductsorproductgroupsfromtheindividualEKsarepublishedontheZLSwebsite2andapplyfromthetimeofpublication.

Table1presentsthemaximumlevelsofPAHinproductmaterials,whichmustnotbeexceeded.TheprovisionsofthisdocumentwithregardtothePAHcontentdonotapplyifotherlegislationlaysdowncorrespondingorfurtherrequirementsforthePAHcontent.Thisappliesonlytothematerialorcomponent/assemblyandnottotheproductasawhole.MaterialsandpartsoftheproductthatarenotcoveredbyotherlegislativeprovisionsmustbeassessedwithintheframeworkoftheprocedureforawardingtheGSmarkinaccordancewiththerequirementsofthePAHdocument.

Itmustbeensuredthatthemethodoftestingcanactuallyachievethelimitofquantificationof

0.2mg/kgforeachindividualPAHcomponent3.

Atthesametime,methodandmatrixeffects,aswellasthemeasurementuncertainty,theefficiencyofextractionandlossesduringpurificationmustbeconsidered.

mg/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）

Toysinthescopeof2021/48/EC

Otherproductsinthescope

ofProdSG

Toysinthescopeof2021/48/EC

Otherproductsinthescope

ofProdSG

BENZO（a）PYRENE

mg/kg

<1

BENZO（e）PYREN

Emg/kg

<1

BENZO（a）ANTHRACENE

mg/kg

<1

BENZO（b）FLUORANTHENE

mg/kg

<1

BENZO（j）FLUORANTHENE

mg/kg

<1

BENZO（k）FLUORANTHENE

mg/kg

<1

CHRYSEN

Emg/kg

<1

DIBENZO（a,h）ANTHRACEN

Emg/kg

<1

BENZO（g,h,i）PERYLENE

mg/kg

<1

INDENO（l,2,3-cd）PYRENE

mg/kg

<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）No1272/2021）

3.3Testingandassessment

Thetestinginstructionsfoundintheannexdescribethestepsofsamplepreparation,extractionofthePAHs,purificationoftheextract,identificationandquantification;thesemustbeapplieduniformlybyalllaboratoriescarryingouttesting.

TheGSbodyassessesthetestresultsanddecideswhethertheGSmarkcanbeawardedincompliancewiththeotherrequirements.

4.Transitionalregulations/periods

FromJuly1st2021（issuedateoftheGSmarkcertificate）,itiscompulsorytoapplythisdocumentwhenawardingtheGSmarktoproducts.

ThedocumentZEK01.4-08willceasetobevalidfromJune30th2021.

SincetestingforPAHlevelsinproductsconstitutesanoverarchingrequirementforalmostallofthemembersofallofthe〞Erfahrungsaustauschkreise〞（“ExchangeofExperienceGroups〞）,thefollowingprocedureisdefined:

4.1GSmarkcertificates,issuedfromJuly1st2021onwards

（incl.ongoingproceduresthatareconcludedafterJuly1st2021）

CompulsoryapplicationofthisGSspecificationfromJuly1st2021onwards（exception:

see4.3）.

4.2GSmarkcertificates,issuedbeforeJuly1st2021

ExistingGSmarkcertificatesinitiallyremainvalid.

Withintheframeworkofregularcheckstomonitorthemanufacturingprocess（atthelatestwithinoneyearor,incaseswheretheregularmonitoringperiodistwoyears,withintwoyears）,therequirementsunderno.3oftheZEK（“CentralExchangeofExperienceGroup〞）documentwithregardtotheriskassessmentmustbetakenintoaccount,regardlessofwhethertheproductwasfoundinthemanufacturingfacilityornot.If,intheprocess,itisfoundthatthecorrespondingrequirementsarenotmet,theGSmarkcertificatemustbewithdrawni