[Guidance in a Nutshell]_Steps to exporting cosmetic prodcuts to China.pdf

REACH24HConsultingGroup,2013

GuidanceinaNutshell

StepstoexportingcosmeticproductstoChina

Inthisdocument,companiesandindividualsinchargeofexportingcosmeticproductsintoChinawill find a comprehensive and detailed overview of the regulatory procedures, rules andcheckpointsmandatedforpremarketapproval,importationinspectionandmarketsurveillanceofcosmeticsbytheCFDAandAQSIQ.

GuidanceinaNutshellStepstoexportingcosmeticproductstoChina

REACH24HConsultingGroup,20132/10

LegalDisclaimerThis Guidance provides an overview of the regulatory requirements on imported cosmeticproducts and advice on how to comply with regulations. However, users are reminded thatofficialgovernmentregulationRegulationconcerningHygieneSupervisionoverCosmeticsandrelated official documents are the only authentic legal reference. The information in thisdocument does not constitute legal advice.REACH24H ConsultingGroup does not accept anyliabilitywithregardtothecontentsofthisdocument.Ifyouhavequestionsorcommentsinrelationtothisdocumentpleasedonothesitatetocontactus.ContactPersonTommyKongEmail:[email protected]:86057187007517F:86057187007566REACH24H ConsultingGroup, 2013. Reproduction is authorized provided the source is fullyacknowledged in the form "Source: REACH24H Consulting Group, www.reach24h.com", andprovidedwrittennotificationisgiventous([email protected]). LastUpdated:7June2013



TableofContents1. DetermineifyourproductisdefinedasacosmeticinChina....................................................42. Checktheingredientsarepermissableorbanned....................................................................43. Preparethepremarketapplicationdossier.............................................................................54. AppointaResponsibleAgent....................................................................................................65. LabelyourproductaccordingtoChinarules............................................................................66. Checkyourproductclaim.........................................................................................................77. Submittheapplicationdossierforreview................................................................................78. Premarketapproval..................................................................................................................89. CIQInspection...........................................................................................................................810. Inmarketsurveillance...............................................................................................................8



ChinaestablishedthecurrentcosmeticregulatorysystembyenactingtheRegulationconcerningtheHygienicSupervisionofCosmeticProductsin1990,whichwasregulatedundertheauspicesof theMinistryofHealth (MoH).Regulatory responsibilitywas transferred toChinas Food andDrugAdministration(CFDA,formerlySFDA) in2008whichwasprimarilytaskedwithpremarketevaluationofproductswhilstfirststageassessmentofimportedshipmentsofcosmeticproductswasdesignatedtotheChinaInspectionandQuarantineBureau(CIQ).ThisGuidanceprovidesanoverview of the regulatory requirements on imported cosmetic products alongwith practicaladviceonhowtocomplywithregulations.StepstoexportingcosmeticproductstoChina1. DetermineifyourproductisdefinedasacosmeticinChinaArticle 2 of Chinas cosmetic regulation defines cosmetic product as industrially producedchemical product subject to daily use, which are intended to be placed in contact with anyexternalpartsofhumanbody(skin,hairsystem,nails,lipsandoralcavity)byspreading,rubbing,spraying, sprinkling etc., with the purpose of cleansing, correcting body odors, protecting,maintainfunctionorchangingtheirappearance. This definition is important for productswhich are at the borderline between cosmetics andotherproduct types, suchaswetwipe.Thearbitrarydefining criteriadelineatingcosmeticandhygienicproductscanbedifficulttoascertain,howeverthedistinction isextremely importantasthe regulatory requirementsvaryquiteconsiderably. (SeeGuidance inaNutshell regarding theChineseregulatoryrequirementsofwetwipesformoredetailedexplanation.)

2. CheckwhetheringredientsarepermissibleorbannedChinaregulatedthecosmeticingredientsbasedontheHygienicStandardsofCosmeticsissuedin1987priortotheenactmentofcosmeticregulation,whichcoveredtheregulated ingredientsofprohibitedsubstances(359entries),restrictedsubstances(57entries),preservatives(66entries),UVFilters(36entries)andSkinColorants(67entries).Chinaprimarily regulates themarketbycompiling listsofpermissibleor restricted inventories.Reference to these inventories is the foundation upon which regulatory compliance is built.Promulgatingstandardsandregulationsleadstoconstantamendmentsandupdatestotheselistsofregulatedingredients.Inadditiontothistheinfluenceofforeignregulatoryframeworksisalsoevidencedby the inclusionofbannedand restricted substanceswhichbothmodel andderiveinspirationfrominternationalregulatorytrends(e.g.2003amendmentsonEUCosmeticDirective,whichinstigatedtheinclusionofnumeroussubstancestotherestrictedinventory)The table below outlines the nine inventories encompassing regulated ingredients (hereafterreferred as 9Regulated Lists), and the table below shows the related name and date of



publication. Formore information,youcan refer to thedocument regarding the introductionof the listsofregulated cosmetic ingredients in China, which details the entries of each list and theaccompanyingregulatoryrequirementsalongwiththeimplicationsforenterprise.

ListName FirstPublication CurrentVersionInventoryofExistingCosmeticIngredientsinChina 2003 2013ListofStandardizedChineseINCIName 2007 2010ListofSubstancesProhibitedinCosmeticProducts 1987 2007ListofSubstancesRestrictedinCosmeticProducts 1987 2007ListofColorantsAllowedinCosmeticProducts 1987 2007ListofPreservativesAllowedinCosmeticProducts 1987 2007ListofUVFiltersAllowedinCosmeticProducts 1987 2007ListofHairColorantsAllowedinCosmeticProducts 2007 2007ListofApprovedNewCosmeticIngredients 2004 2012

3. PreparethepremarketapplicationdossierA premarket application dossier must be compiled for each imported cosmetic product andsubmitted to CFDA for evaluation on the quality, safety andlabeling. The application dossierconsistsofalltheevidenceofconformityandconsistedofXXpartspresentasbelow.No. Items Remarks1. Applicationform Mustbesignedandstamped2. Product naming

statementThe Chinese naming requirements must be complied andclarifyanyspecificitems,suchasforparticularpopulation

3. Quality controlspecification

TheoriginalQCspecificationandothersupportivematerialshouldbeprovided,ifnecessary

4. Manufacturingdescription

All the ingredients must be involved in the productiondescription,plusprimaryprocessparametersandchart

5. Formulation All the ingredients must be listed and identified, and thecertificateofanalysiswillbenecessarysometime

6. Package TheoriginalpackagemustbeincludedandthenewlydesignedforChinamarketneed tobe submittedaswell, furthermore,Chinesecompliantlabelmustbeprovided

7. Testingreports CosmetictypedependentsafetytestingmustbecarriedoutbyCFDAapproved institutes inChina,except the sunprotectionfactordetermination

8. Safetyevaluationontheriskconcernsubstance(1)

Informationontheidentities,analyticaloutcomeandriskassessmentregardingthepotentialriskconcernsubstanceshouldbeprovided

9. Functionalingredients The functional ingredients of special cosmetics(2) must beidentifiedandsupportingmaterialbeprovideaswell



10. Authorizationletter Theevidenceoftheassignmentoflocalresponsibleagent11. Certificateoffreesaleor

otherequivalentThedocumentmustbeprovidedbytheauthorityor industryassociationofthecountryoforigin

12. Safetycommitmentoningredientsfrommadcowinfectiousarea

ThiscomesfromtheoutbreakofEUmadcowdiseasein2001,andsafetycommitmentisrequired,insteadofofficialcosmeticquarantinecertificatein2007

13. Technicalrequirements FocusingonthequalityrequirementbesidesQCspecification,includingQCmethods,usageinstruction,storageconditionandshelftime.

14. Originalproduct OneproductforChinesemarketingshouldbeprovided(1) Riskconcernsubstancesrefertoanyharmfulchemicals,typicallytheprohibitedsubstances(egdioxinfrom

PEGderivatives),generatingfromimpuritiesofsyntheticornaturalingredientsorthemanufacturingprocess(2) Specialcosmeticsrefertotheproductswithspecialfunction,includinghairgrowthproducts,hairdye,

productsforwavingorstraighteninghair,hairremovalproducts,beautybreastproducts,productsforbodyfitness(eg.slimmingcream),deodorants,productsforantispotorUVprotection.

4. AppointaResponsibleAgentA fundamentalrequirement forCosmetic importerswishingtoentertheChineseMarket istheappointment of a Chinese legal entity or Responsible Agent (RA) to represent their companyduringtheapplicationprocedure.ChinarequeststhatboththeoverseamanufactureandlocalRAensuretheproductcomplywithChinesenationalstandardshowevertherearenoclearlydefinedregulationsunderpinningthisrequirement.RAscanbeaChinesesubsidiarycompany,importerorotherindependentagentbusiness,suchasREACH24H. (Pleasebeawarethat,onlytheoverseamanufactureortheconsignorincaseofOEM,isqualifiedtobetheapplicanttoassigntheRA forapplication,and itsnamewillbe listed intheapprovalacknowledgementdocument,distributorsorwholesalersdonotqualifyasavalidRA.)

5. LabelyourproductaccordingtoChinarulesCFDA provide two options for labeling imported cosmetics 1)The original upon with Chinesetranslation2)Confirmwithnational labelingstandardsanduseaChinesecommercial labelandpackage,(hereafterknowasChineselabel).Labelingreferstothecombinationofwords,numbers,figuresorinstructionswhichappearonthecontainerorpacking.ThefollowinginformationmustbeincludedintheChineselabel, Productname theChineseproductnamegeneratedaccording to theCosmeticNaming

Rule Addressofproducerthenameandaddressoftheoverseamanufacture CountryoforiginthecountryoforiginmustbeindicatedontheChineselabel ApprovalIDnumbertheIDnumberontheapprovalacknowledgement,suchas



J20130000,representingtheproducttype,approveddateandsequencenumber Listofingredientsalltheingredientswithconcentrationover1.0%mustbeidentifiedwith

ChineseINCIname Date of production and durabilitycombination of production date and period after

manufacturing (suchas6months),or thebatchnumberanddateofminimumdurability(suchas20131231)

Particular precautions for use warning and condition of use for products containingrestricted substance (eg. Dichloromethane, which should be indicated, while the maxconcentrationislessthan0.5%)orspecialcosmetics(eg.hairdye)

Storageconditionanduseinstructionshouldbeprovidedifnecessaryforsafetyassurance OtherthelocaldistributororwholesalercanbeidentifiedaswellOthernotesonlabeling LanguageoriginallabelcanberemainedbyattachingtheChineselabel,andthesimplified

Chineseisofficialrequired,plusnecessarytraditionalChineseorotherlanguagecharacters Smallpackagingastotheproductwithnominalcontentlessthan15gor15mL,whereit

isnotpracticaltoprintwarning,ingredientsandproductuseinformationonthepackingorcontaineritself,aleaflet,labelorcardshouldbeprovidedcontainingtherelatedinformation,andmakingreferencethroughnecessarywordsonthelabel,suchasfindtheingredientsontheleafletinside.

LabelingnamomaterialsthisnewobligationunderEUcosmeticregulationisnotrequiredin China, however, the application dossier should specify the nano property for someingredients,suchasZnOforbabyproducts

Labeling inspection CFDA responsible for the labeling review prior to marking, ChinaInspection and Quarantine Bureau (CIQ) charged with the labeling assessment prior tocustomclearance,andAdministrationofQualitySupervision(AQS) inspectingthe labelsofinmarketproducts.

CIQLabelallthe importedcosmeticmustbeattachedtheCIQ labelandthisrequirement hasbeendeclinedforimportedcosmeticsafter1Feb2012

6. CheckyourproductclaimCFDApromulgated special rulesandguidelineson theproduct claimandnameon theChineselabel.Medicinalortherapeuticfunctionclaimsareprohibitedalongwithinclusionofmisleadinginformation.Thegeneralprincipleisthatindustrycantclaimthefunctionsorfeatureswhichtheproductsdonotpossess.LocalexpertisewillbenecessaryforbalancingcompliancewithChineseclaim requirements and the addressing the interestsofmanufacturerswho relyon the addedvaluederivedfrominclusionofcertainclaimsintheirmarketingstrategies.

7. SubmittheapplicationdossierforreviewSubmissionofahardcopypaperdossierisstillrequired;esubmissionisonlyapplicableforparts



ofthedossier, includingthe informationonthe formulation (part5)andtechnicalrequirement(part 13).The premarket evaluation process consists of the dossier completeness check(AdministrativeProcessingCenterofCFDA),compliance review (Center forCosmeticEvaluationofCFDA)anddisclosureofoutcomeonCFDAwebsite,andtypicallytheperiodofreviewprocesswillbearound6070workingdays.

8. PremarketapprovalAllthe importedcosmeticproductsaresubjecttothepremarketevaluationcarriedoutbytheCFDA.Acknowledgementofapprovalmarksthefirstsuccessfulstepforexporting.Thefollowinginformationwillbepresentontheapprovaldocument, IDnumber indicating theproduct type, specialorordinary, approval year and sequence

number ProductandproducernameboththeChineseandoriginalname Producttypeindicatethetypeofspecialcosmetics,suchasantispotcosmetics Countryoforigincountrynameandproduceraddress ResponsibleagentthenameandaddressofRA Approvaldatemarksthestartingpointof4yearvalidperiodofapproval

acknowledgementandrefreshapplicationshouldbesubmittedin4monthspriortotheexpireddate

9. CIQInspectionForeachshipmentofcosmeticproduct,the local importeror itsagentshouldapplyfortheCIQinspectioncarriedoutbythelocaloffices,suchasShanghaiCIQ.Theinspectionprocessincludesonsiteexaminationofthelabelorpackage,samplingortestingbasedontheoutcomeofonsiteexamination and other findings, and finally the issuance of the CIQ Certificate, which is theultimaterequirementforcustomclearance.

10. InMarketSurveillanceCFDAandAQSIQwillcarryout the inmarketsurveillanceunder theirownauthorities,suchastheplantonsiteinspectionforhygienicconditionandgoodqualitymanagementsystem,productcontamination investigation and sampling from the supermarket or cosmetic stores as well,furthermore, the State Administration for Industry and Commerce (SAIC) will monitor theadvertisingactivitiesofcommercialcosmeticproduct.



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[Guidance in a Nutshell]_Steps to exporting cosmetic prodcuts to China.pdf