歐盟企業(yè)在中國建議書（2024-2025）化妝品工作組 (英文)

Europeanchamber中國歐盟商會

CosmeticsWorkingGroup

KeyRecommendations

1.GraduallyImplementtheCosmeticsSafetyAssessmentinStages,

LearnfromInternationalProgressinthisAreaandFurtherRescindAnimalTestingRequirements

?IssuepracticaltechnicalguidelinesbasedonEuropeanUnion(EU)andinternationalsafetyassessmentapproaches.

?ProvidesafetyassessmenttrainingbytheNationalMedicalProductsAdministration(NMPA)tobothregistrationreviewersandsafetyassessorsofcosmeticscompanies.

?Abolishmandatoryanimaltestingforfinishedspecialcosmetics.

SectionThree:Goods

2.BoostInnovationthroughFeasibleRegulatoryOversightModelsand

Pathways

2.1PersonalisedCosmetics

?Resumeandexpandtheone-yearpilotprogrammesonpersonalisedcosmeticstoallowformoreprojectstotakeplaceinmoreprovinces/cities.

?Establishdedicatedcosmeticsregulationsfitforpersonalisedcosmetics,detailingprocessesforproductregistration,safetyassessments,efficacysubstantiationandgoodmanufacturingpractice(GMP)requirements.

?Extendthepermittedproductcategoriesofpersonalisedcosmeticstoallcosmeticsproducts,includingspecialcosmetics.

2.2NewIngredients

?Adoptthemostadvancedcosmeticssafetyassessmentapproaches,inlinewithOrganisationforEconomicCo-operationandDevelopmentandEU-validatedtestingmethodsthatareviablealternativestoanimaltesting.

?EstablishanotherregulatorypathwaytoallowtheuseinChinaofnewingredientsthathavealreadybeenapprovedbyEUregulators.

2.3SustainableDevelopmentandtheCircularEconomy

?FostercollaborationbetweengovernmentandbusinessestodevelopawhitepaperonthegreendevelopmentofChina’scosmeticsindustry,disseminateknowledgeaboutgreencosmetics,andcultivateenvironmentalresponsibilityandgreenconsumptionhabits.

?PromoteChina'sparticipationandrecognitionofinternationalstandardsandcertificationsrelatedtogreencosmeticsingredients,packagingmaterials,andproductlifecycle-basedproductenvironmentalassessmentsystems.

2.4Standardisation

?EncourageChineseregulatoryauthoritiestoactivelyengageinthetechnicaldiscussionsonanddevelopmentofnationalcosmeticsstandards.

?Expeditetherecognitionoradaptationofinternationalcosmeticsstandardstominimisetradeandcompliancehurdles.

?Promptlyaddressregistrationandnotificationcomplianceissuesstemmingfromtheimplementationofinternationalcosmeticsstandards.

204CosmeticsWorkingGroup

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EuropeanBusinessinChinaPositionPaper歐盟企業(yè)在中國建議書

2.5AssistanceinConstructingHainan’sInternationalFreeTradePortand

ImplementationofDifferentiatedManagementforHainan’sDuty-freeChannels

?IntroduceelectroniclabellingforHainanoffshore,duty-freeproductssothattherequiredregulatoryinformationcanbedisplayeddigitally,reducingtheneedforphysicallabels.

?Allowmanufacturerstoretainsamplesintheircountryoforigin,streamliningtheprocessforHainanoffshoreduty-freeproducts.

?GrantHainan’sregulatoryauthoritiesthepowertoregisterspecialcosmeticsandestablishsimplifiedregistrationproceduresforthosesoldexclusivelyduty-freeonHainan’soutlyingislands.

3.EnhanceProductApplicationandTechnicalEvaluationEffectiveness

3.1RawMaterialInformationSubmission

?Utilisetherawmaterialsafetyinformationapplicationplatformsolelyasareferencefordatacollection,notasadeterminantforevaluatingcosmeticsformulas.

SectionThree:Goods

?Empowercosmeticsregistrants/filerstoindependentlyprovideanddeclarerawmaterialsafetyinformation,contingentuponbotharobustscientificbasisandresearchdata.

3.2LabellingofAllergens

?Permitcompaniesimportingcosmeticstosubmitonlytheoriginalpackagingwithupdatedallergenlabelling,eliminatingtheneedforapplicationchangesorre-registrationornotification.

?Enablecompanieswithimportedcosmeticsnotyetonthemarkettoincludenewallergensontheoriginalpackagingwithinthe‘ingredientlist’or‘warningstatement’sectionsoftheChineselabels,withexplanationsintheformulatable’s‘remarkscolumn’,removingthenecessityfornewcosmeticsingredientnotificationsorregistrationsforfragranceallergens.

3.3Low-microbialRiskCosmeticsProducts

?AcceptthecriteriastipulatedintheInternationalOrganizationforStandardization(ISO)standardforlow-microbialriskproducts,andacceptqualityassurance(QA)controlmeasuresdesignedbycosmeticscompaniesinsteadofmandatingbatch-by-batchtesting.

3.4Children’sCosmetics

?Enhancetheprinciplesandguidelinesgoverningthesafeuseofingredientsinchildren’scosmetics.

?OptimiseChina’scosmeticsingredientdatabasebyfocussingonimprovingthesafetydatabasespecificallyforchildren’scosmetics.

?Facilitateinternationalexchangesandjointlydevelopapracticalformulasafetyassessmentandriskcommunicationmechanismforchildren’scosmetics.

3.5TechnicalEvaluationsofCosmeticswithAnti-hairLossorWhiteningFunctions

?AcceleratethereleaseoftechnicalguidancedocumentsthataresuitablefortheR&Dofcosmeticswithspotremovalandwhiteningfunctionsintheindustry,whileconductingtrainingandexchanges.

?Considertheuniquemechanismofanti-hairlossproductsbeforescientificallyformulatingsuitabletechnicalguidancedocumentsfortheirreview,andpromoterelevantexchangesbetweenregulatorsandindustryplayers,includingtrainingwherenecessary.

3.6ReviewCriteria

?Enhancethetrainingandguidanceofreviewagenciesnationwidetoestablishconsistentreviewcriteria.

?Createadirectdialoguemechanismbetweentheindustryandreviewagenciestogatherfeedbackonreviewprocessesandcases,andtopromptlyupdatealistoffrequentlyaskedquestions.

?Promotegovernment-industrycooperation,anddevelopclear,detailedandunifiedcosmeticsreviewstandards.

CosmeticsWorkingGroup205

Europeanchamber中國歐盟商會

4.StandardiseSpecificIngredientClaimsonCosmeticsLabels,Promotethe

ApplicationofEquivalentEvaluationsandPermittheUseofElectronicLabels

4.1SpecificIngredientsClaims

?Developclear,detailedandstandardisedcriteriaforreviewingcosmeticslabellingclaimsforrawmaterialsorclassifyingrequirementsforreviewsothatrawmaterialclaimsaresubstantiatedwithappropriateevidencebasedondifferentscenarios.

?Establisharegularcommunicationchannelforspecificingredientclaimstoprovideexplanationsfordisputedclaimsandseekagreement,whilealsocontinuouslyreleasinginterpretivedocuments,researchingspecificindustrysituationsandofferingreasonablereviewdirectives.

?Clarifythatefficacyclaimsofingredientsthatcanbeidentifiedthroughsensoryperceptioncanbeexemptfromtherequirementtosubmitrelevantefficacysummaries.

4.2EquivalentEvaluations

?Extendtheapplicationscopeoftheguidingprincipleofequivalentevaluationstoallproductefficacies,notonlymulti-colourcosmeticsproducts.

SectionThree:Goods

?Acceptanapplicant’srationaleastowhyminordifferencesinformulasdonotaffectefficacy,andallowforslightadjustmentsofessencesandantisepticsbesidespigments.

?Researchtheimpactofvariouscosmeticsingredientsondifferentefficaciesandprogressivelybroadentherangeofingredientspermittedforminoradjustmentsundertheequivalentevaluationguideline.

4.3ElectronicLabel

?InvestigatetheuseofQRcodesandsimilartechnologiestoprovideconsumerswithelectroniclabelsandinformation,reducingrelianceontraditionalpaperlabelsandleaflets.

5.AlignOverseasInspectionswithForeignStandards,PromoteCompliance

inAdvertisingandE-commerce,andEnsureRegulatoryConsensusforSeamlessPre-assessmentandPost-supervisionofCosmetics

5.1OverseasInspections

?Conducttrainingforcosmeticsenterprisesonoverseasinspectionproceduresassoonaspossible.

?Considerthecosmeticsregulationsofanoverseascompany’slocationduringinspections,recognisingtheirproductionandqualitymanagementsystems.

5.2AdvertisingandOnlineOperationManagement

?Solicitindustryfeedbacktoavoidsettingoverlyrigidmandatoryrequirementsduringthecreationandenforcementoflawsandregulations.

?Provideampleopportunityforcompaniestodemonstratecomplianceinpost-marketsurveillance,therebyempoweringcompanieswithgreaterresponsibility.

?Developandimplementprotocolstohandleongoingandunjustifiedcomplaintsfromprofessionalcomplainants,decreasecomplaintsthatarenotrelatedtotypicalproductusage,andeventuallypreventactivitiesthatdisruptnormalmarketfunctioning.

?Releaseclearandtimelyinterpretationsonindustrytrendsandregulatorydetailstoprovidecompanieswithongoingguidance.

5.3ConnectionbetweenPost-marketSurveillanceandPre-marketEvaluation

?EstablishascientificsupervisionmechanismtoensureconsensusamonglocalauthoritiesatalllevelsaboutinterpretationsoftheimplementationofnewregulatoryrequirementsundertheCSAR.

?Introduceaconsultationproceduretofacilitatecommunicationbetweencompaniesandregulatoryauthorities,ensuringallregulatorydecisionsarebasedongoodprofessionalknowledgeandregulatoryunderstanding.

206CosmeticsWorkingGroup

RecentDevelopments

China’scosmeticsindustrygrew5.1percentin2023,1almostmatchingtheofficialfigureforgrossdomesticproductgrowthof5.2percent,withretailsalesofcosmeticsreachingChineseyuan(CNY)414.2billion.2However,China’simportsofcosmeticsandtoiletrieshavebeendeclining.AccordingtotheGeneralAdministrationofCustomsofChina(GACC),importsinthefirstquarterof2024decreased17.1percentyear-on-year.3Oneoftheprimaryreasonsattributedtothisdeclineistheimplementationofstricterindustryregulations,whichnecessitatecompliancefromimporterslookingtoaccesstheChinesemarket.

FollowingtheofficialimplementationoftheCosmeticsSupervisionandAdministrationRegulation(CSAR)on1stJanuary2021,4theNationalMedicalProductsAdministration(NMPA)releasedsecondaryregulationsandrelatedguidancedocumentsoverthepastyear.AftermanymonthsofcontinuousadvocacybytheCosmeticsWorkingGroup,themostprominentrecentregulatorydevelopmentwasthepostponementoftheimplementationofthefullcosmeticssafetyassessmentbytheNMPAto1stMay2025.Thishasprovidedtheindustrywithanadditionalone-yeargraceperiodtoadjusttothenewrules.TheMeasuresforOptimisingCosmeticsSafetyAssessmentManagement,5alongwithsevenguidelines,werereleasedinApril2024,providingtechnicalsupportforimplementationofthecosmeticssafetyassessment.

1Nationaleconomyreboundsin2023high-qualitydevelopmentadvancessolidly,NBS,17thJanuary2024,viewed30thApril2024,<

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zxfb/202401/t20240117_1946624.html

>

2TotalretailsalesofconsumergoodsinDecember,NBS,18thJanuary2024,viewed13thApril2024,<

/english/PressRelease/202402/

t20240201_1947119.html

>

3China'sTotalExportandImportValuesinMarch2024,GACC,12thApril2024,viewed13thApril2024,<

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gk/2799825/302274/302275/5810566/index.html

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4CosmeticsSupervisionandAdministrationRegulation,NMPA,29thJune2020,viewed13thApril2024,<

/xxgk/fgwj/

flxzhfg/20200629190501801.html

>

5MeasurestoOptimisetheSafetyAssessmentManagementofCosmetics(2024No.50),NMPA,22ndApril2020,viewed13thApril2024,<

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cn/xxgk/ggtg/hzhpggtg/jmhzhptg/20240422172542190.html

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KeyRecommendations

1.GraduallyImplementtheCosmetics

SafetyAssessmentinStages,LearnfromInternationalProgressinthisAreaandFurtherRescindAnimalTestingRequirements

Concern

ThegapbetweenChina’simplementationofthefullsafetyassessmentrequirementsandindustrypracticesinEuropewillleadtochallengesinproductregistrationandnotification.

Assessment

TheNMPAreleasedaseriesoftechnicalguidelinesonthedetailedrequirementsforthefullcosmeticssafetyassessmentreportthatmustbecarriedoutbyanycompanywishingtoimport,distributeandsellcosmeticsintheChinesemarketfrom1stMay2025onwards.

Currently,China’sregulatoryrequirementsforsafetyassessmentreportsarenotfullyinlinewithEuropeanUnion(EU)andinternationalapproaches.Asaresult,Europeanindustryplayersmaybeunabletomeetthetoxicitydatarequirementsforthefullsafetyassessmentreports,astherequirementsmayimplythatanimaltestingisrequired,whichisnotpermittedintheEU.

Theworkinggrouprecommendsthatmandatoryanimaltestingoffinishedspecialcosmeticsshouldbeabolished,asfullsafetyassessmentreportsofallrawmaterialsusedincosmeticsproductsalreadyensuretheirsafeuse.

Recommendations

?IssuepracticaltechnicalguidelinesbasedonEUandinternationalsafetyassessmentapproaches.

?ProvidesafetyassessmenttrainingbytheNMPAtobothregistrationreviewersandsafetyassessorsofcosmeticscompanies.

?Abolishmandatoryanimaltestingforfinishedspecialcosmetics.

CosmeticsWorkingGroup207

SectionThree:Goods

SectionThree:Goods

Europeanchamber中國歐盟商會

2.BoostInnovationthroughFeasible

RegulatoryOversightModelsandPathways

2.1PersonalisedCosmetics

Concern

Thelackofpolicysupportforinnovativepersonalisedcosmeticshindersinnovationinthecosmeticsindustry.

Assessment

Followingthecompletionoftheone-yearnationalpilotprojectsforpersonalisedcosmeticsservices,6whichwerelimitedtoonlyfiveprovinces/citiesundertakingamaximumofthreeprojectseach,nonewregulationsoninnovationofpersonalisedcosmeticshavebeen

forthcoming.However,thereisstillastrongappetiteamongindustryplayerstolaunchmorepersonalisedcosmeticsprojectsnationwide.

Atthesametime,thecurrentproductregistrationandgoodmanufacturingpractice(GMP)requirements,whichcanbeimplementedinfactories,arenotsuitablefortheinnovationofpersonalisedcosmetics.Personalisedproductservicesarepresentlysubjecttocase-by-casepre-marketapproval.Theevaluationisbasedonsafetyandefficacy,aswellasthemanagementofnotificationdossierscomprisingfixedformulacontent.Becausethismethodisconstrainedtoalimitedrangeofproductformulasitcannotbeappliedtopersonalisedproductservicesthathavedynamicallychangingformulas.

Recommendations

?Resumeandexpandtheone-yearpilotprogrammesonpersonalisedcosmeticstoallowformoreprojectstotakeplaceinmoreprovinces/cities.

?Establishdedicatedcosmeticsregulationsfitforpersonalisedcosmetics,detailingprocessesforproductregistration,safetyassessments,efficacysubstantiationandGMPrequirements.

?Extendthepermittedproductcategoriesofpersonalisedcosmeticstoallcosmeticsproducts,includingspecialcosmetics.

6AnnouncementonConductingOne-yearPilotProjectsforPersonalisedCosmeticServices,NMPA,7thNovember2022,viewed13thApril2024,<

.

cn/zhengce/zhengceku/2022-11/11/content_5726121.htm

>

208CosmeticsWorkingGroup

2.2NewIngredients

Concern

Animaltestingdataarestillrequiredformostnewingredients,whichconstitutesamarketaccessbarrierforoverseascompanieslookingtointroducenewingredientsinChina.

Assessment

Intermsofrawmaterials,substancesthatarenotlistedintheNMPA’sCatalogueofUsedCosmeticsRawMaterials7canonlybeadoptedthroughnewingredientregistration,whichrequiresthattheyundergoanimaltesting.However,duetothefactthatanimaltestingisbannedintheEU,EUcompaniesareunabletomeetthisregistrationrequirementforsomeinnovativeproducts.Thismeansthatsomenewingredients,suchasultraviolet(UV)filters,preservatives,hairdyesandcolorants,whichhavealreadybeenapprovedforsafetybyEUcosmeticsregulators,areblockedfromenteringtheChinesemarket.

Recommendations

?Adoptthemostadvancedcosmeticssafetyassessmentapproaches,inlinewithOrganisationforEconomicCo-operationandDevelopmentandEU-validatedtestingmethodsthatareviablealternativestoanimaltesting.

?EstablishanotherregulatorypathwaytoallowtheuseinChinaofnewingredientsthathavealreadybeenapprovedbyEUregulators.

2.3SustainableDevelopmentandtheCircular

Economy

Concern

Morecanbedoneatboththeconsumerandindustryleveltopromotegreencosmetics.

Assessment

Theforeigncosmeticsindustrypioneeredtheconceptof‘green’cosmetics,emphasisingtheimportanceofsafe,effective,andenvironmentallyfriendlypackagingandrawmaterials.MostEUcompanieshavealreadyadoptedclearsustainabledevelopmentgoals,includingreducingcarbonemissions,plasticuseandrelianceon

7AnnouncementoftheNationalMedicalProductsAdministrationontheIssuanceofCatalogueofUsedCosmeticRawMaterials(2021)(No.62of2021),NMPA,30thApril2021,viewed13thApril2024,<

/xxgk/ggtg/

hzhpggtg/jmhzhptg/20210430162707173.html

>

virgin,fossil-basedplastics.

InJanuary2023,China’sStateCouncilissuedtheWhitePaperonGreenDevelopmentintheNewEra,8advocatingforagreendevelopmentpathandoverallprotectionofthenaturalecosystemthroughregionalgreeninitiatives,industrialtransformationandpromotinggreenproductconsumption.However,whileenhancingbothindustryandconsumerawarenessiscrucialforadvancingthedevelopmentofgreencosmetics,Chinahasyettoestablishauniversallyaccepteddefinitionofgreencosmetics.Thishasresultedindifferentunderstandingamongbothconsumersandsomeindustryplayers,duetotheabsenceofclearstandards.

Recommendations

?FostercollaborationbetweengovernmentandbusinessestodevelopawhitepaperonthegreendevelopmentofChina’scosmeticsindustry,disseminateknowledgeaboutgreencosmetics,andcultivateenvironmentalresponsibilityandgreenconsumptionhabits.

?PromoteChina'sparticipationandrecognitionofinternationalstandardsandcertificationsrelatedtogreencosmeticsingredients,packagingmaterials,andproductlifecycle-basedproductenvironmentalassessmentsystems.

2.4Standardisation

Concern

ChineseregulatorsdonotrecognisemostInternationalOrganizationforStandardization(ISO)cosmeticstandards,leadingtochallengesinproductimportregistrations,GMPauditsandcompliancewithproductlabellingrequirements.

Assessment

China’snon-acceptanceofinternationalcosmeticsstandardscanmakeitdifficultforimporterstomeetlocalcompliancestandards.Forinstance,productswithlowmicrobiologicalrisksthatareexemptfrominspectionsunderinternationalstandardsmaynotfulfilChina’sregistrationandnotificationcriteria.9Also,productsthatcanbemarketedas‘organic’or‘natural’

8WhitePaperonChina'sGreenDevelopmentintheNewEra,StateCouncil,19thJanuary2023,viewed13thApril2024,<

/xinwen/2023-01/19/

content_5737923.htm?eqid=f80ca20500135119000000046469d4ba

>

9Cosmetics-Microbiology-Guidelinesfortheriskassessmentandidentificationofmicrobiologicallylow-riskproducts,ISO,March2017,viewed13thApril2024,<

/standard/68310.html

>

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internationally,cannotbemarketedassuchinChina.AndoverseasmanufacturersadheringtointernationalGMPforcosmeticsmightencounterissueswithoverseasinspectionsandinquiries.

Recommendations

?EncourageChineseregulatoryauthoritiestoactivelyengageinthetechnicaldiscussionsonanddevelopmentofnationalcosmeticsstandards.

?Expeditetherecognitionoradaptationofinternationalcosmeticsstandardstominimisetradeandcompliancehurdles.

?Promptlyaddressregistrationandnotificationcomplianceissuesstemmingfromtheimplementation

ofinternationalcosmeticsstandards.

2.5AssistanceinConstructingHainan’sInternational

FreeTradePortandImplementationofDifferentiatedManagementforHainan’sDuty-freeChannels

Concern

Hainan’soffshoreduty-freeproductsmustadheretotheCSAR,howevertheuniquetrademodelpresentscompliancechallenges.

Assessment

Hainan’soffshoreduty-freecosmeticsoperationsaremorecomplexandcostlycomparedtotraditionaltrade,necessitatingChineselabellingonboththeinnerandouterpackaging.Additionally,logisticalandoperationaldiscrepanciesariseinsampleretentionforimportedbatchesduetothedispersedlocationsofresponsiblepersonsinChina,andtheuniqueoperationaltraitsoflicensedimporters.10Thelengthyregistrationperiodforspecialcosmeticsisalsoatoddswiththefast-pacedconsumerdemandsofHainan’sduty-freemarket.

Recommendations

?IntroduceelectroniclabellingforHainanoffshore,duty-freeproductssothattherequiredregulatoryinformationcanbedisplayeddigitally,reducingtheneedforphysicallabels.

?Allowmanufacturerstoretainsamplesintheircountryoforigin,streamliningtheprocessforHainanoffshoreduty-freeproducts.

10TheregulationmandatesthattheresponsiblepersonmustmaintainretentionsamplesforimportedbatchesofHainanoffshoreduty-freeproducts.However,theresponsiblepersonisnotsituatedinHainanProvince,andtheimportedbatchesaredirectlymanagedbyHainanoffshoreduty-freedistributors,notbytheresponsibleperson.

CosmeticsWorkingGroup209

SectionThree:Goods

SectionThree:Goods

Europeanchamber中國歐盟商會

?GrantHainan’sregulatoryauthoritiesthepowertoregisterspecialcosmeticsandestablishsimplifiedregistrationproceduresforthosesoldexclusivelyduty-freeonHainan’soutlyingislands.

3.EnhanceProductApplicationand

TechnicalEvaluationEffectiveness

3.1RawMaterialInformationSubmission

Concern

Whenarawmaterialsubmissioncodedoesnotmatchtherelevantdatastoredonthesafetyinformationplatform,theapplicationdossiersmayberejectedor

facechallengesduringtheproductfiling/registrationprocess.

Assessment

Divergentinterpretationsofrawmaterialcompositionandimpuritiesbetweencosmeticregistrant/filersandrawmaterialmanufacturers,coupledwithincompletesharingofinformationbymanufacturers,canresultindiscrepanciesbetweensubmittedrawmaterialcompositionsandmanufacturer-providedinformationinsafetyapplications.Thesediscrepanciesposechallengesduringtheregistrationprocess,impedingthesmoothmarketentryandoperationofthecosmeticsindustryinChina,therebyhinderingtheindustry’sgrowth.

Recommendations

?Utilisetherawmaterialsafetyinformationapplicationplatformsolelyasareferencefordatacollection,notasadeterminantforevaluatingcosmeticsformulas.

?Empowercosmeticsregistrants/filerstoindependentlyprovideanddeclarerawmaterialsafetyinformation,contingentuponbotharobustscientificbasisandresearchdata.

3.2LabellingofAllergens

Concern

ArecentEUregulationupdateposessignificantchallengesforimportedcosmetics,mandatingsubstantialpackagingalterationsandpotentiallynecessitatingingredientmanagementupdates,re-registrationandre-filing,whichcouldadverselyaffectbusinesses.

210CosmeticsWorkingGroup

Assessment

TheEuropeanCommission’sRegulation(EU)No.2023/1545hasamendedAnnexIIIofEUCosmeticsRegulation(EC)No.1223/2009,11&12expandingthelistoffragranceallergensthatmustbelabelledoncosmeticsfrom24to81.Effectivefrom16thAugust2023,thisregulationimpactsallEUmemberstates.Therevisionbuildsuponexistinglabellingrequirementsforfragranceallergensthathavelongbeenpresentincosmeticsessences.SomemembersoftheCosmeticsWorkingGrouphavealreadyinitiatedchangestoproductpackaging,anticipatingthatnumerousEUcosmeticswillundergopackagingandallergenlabellingupdateswithinthenextonetothreeyears.

UnderChina’scurrentCosmeticsLabellingAdministrativeMeasuresandtheProvisionsontheManagementofCosmeticsRegistrationandNotificationDossiers,13&14safetyandefficacyclaimsonthelabelsofimportedcosmeticsmustalignwiththeoriginallabels,andmustincludeanaccuratereflectionandexplanationoflistedfragranceallergens.IfChineseregulatoryauthoritiesinterprettheselabellingchangesasformulaalterationsornewallergensasnewingredients,itwouldcompelare-registrationornotificationprocessformanyEUcosmeticsinChina,delayingmarketentryfornewproductsandincurringadministrativeburdensandsubstantialmaterialcosts.

Recommendations

?Permitcompaniesimportingcosmeticstosubmitonlytheoriginalpackagingwithupdatedallergenlabelling,eliminatingtheneedforapplicationchangesorre-registrationornotification.

?Enablecompanieswithimportedcosmeticsnotyetonthemarkettoincludenewallergensontheoriginalpackagingwithinthe‘ingredientlist’or

‘warningstatement’sectionsoftheChineselabels,withexplanationsintheformulatable’s‘remarkscolumn’,removingthenecessityfornewcosmetics

11AmendingRegulation(EC)No1223/2009oftheEuropeanParliamentandoftheCouncilasregardsLabellingofFragranceAllergensinCosmeticProduct,

EuropeanCommission,26thJuly2023,viewed13thApril2024,<

https://eur-lex.

europa.eu/eli/reg/2023/1545/oj

>

12Regulation(EC)No1223/2009oftheEuropeanParliamentandoftheCouncilof30November2009oncosmeticproducts,EuropeanCommission,30thNovember2009,viewed13thApril2024,<

https://eur-lex.europa.eu/legal-content/

en/ALL/?uri=CELEX%3A32009R1223

>

13CosmeticsLabellingAdministrativeMeasures(No.77of2021),NMPA,3rdJune2021,viewed13thApril2024,<

/xxgk/fgwj/

xzhgfxwj/20210603171933181.html

>

14ProvisionsfortheManagementofCosmeticsRegistrationandNotificationDossiers(No.32of2021),NMPA,26thFebruary2021,viewed13thApril2024,<

/zhengce/zhengceku/2021-03/04/content_5590288.htm

>

ingredientnotificationsorregistrationsforfragranceallergens.

3.3Low-microbialRiskCosmeticsProducts

Concern

Themicrobialqualitycontrolrequirementforlow-microbialriskproductsisnotalignedwithinternationalstandards,whichresultsinunnecessarycostsforEuropeancosmeticsmanufacturers.

Assessment

Me