PAHs欧盟最新标准样本.docx

PAHs欧盟最新标准样本.docx

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PAHs欧盟最新标准样本

ProductSafetyCommission（AfPS）GSSpecification

Testingandassessmentofpolycyclicaromatichydrocarbons（PAHs）inthecourseofawardingtheGSmark

-Specificationpursuanttoarticle21

（1）no.3oftheProductSafetyAct（ProdSG）–

AfPSGS:

01PAK

Stateofrevision：

August4th，

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.4ththeProductSafetyCommission（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--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）

Toysinthescopeof/48/EC

Otherproductsinthescope

ofProdSG

Toysinthescopeof/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/）

3.3Testingandassessment

Thetestinginstructionsfoundintheannexdescribethestepsofsamplepreparation，extractionofthePAHs，purificationoftheextract，identificationandquantification；thesemustbeapplieduniformlybyalllaboratoriescarryingouttesting.

TheGSbodyassessesthetestresultsanddecideswhethertheGSmarkcanbeawardedincompliancewiththeotherrequirements.

4.Transitionalregulations/periods

FromJuly1st（issuedateoftheGSmarkcertificate），itiscompulsorytoapplythisdocumentwhenawardingtheGSmarktoproducts.

ThedocumentZEK01.4-08willceasetobevalidfromJune30th.

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

4.1GSmarkcertificates，issuedfromJuly1stonwards

（incl.ongoingproceduresthatareconcludedafterJuly1st）

CompulsoryapplicationofthisGSspecificationfromJuly1stonwards（exception：

see4.3）.

4.2GSmarkcertificates，issuedbeforeJuly1st

ExistingGSmarkcertificatesinitiallyremainvalid.

Withintheframeworkofregularcheckstomonitorthemanufacturingprocess（atthelatestwithinoneyearor，incaseswheretheregularmonitoringper