中英对照2020化妆品监督管理条例.docx

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1、RegulationontheSupervisionandAdministrationofCosmeticsDocumentNumber：OrderNo.727oftheStaleCouncilofthePeoplesRepublicofChinaAreaofIxiw:ChemicalProductandItsQualityHealthSupervision1.evelofAuthority：AdministrativeRegulationsIssuingAuthority：StateCouncilDateIssued：06-16-2020EffectiveDate：01-01-2021Sta

2、tus:EffectiveArticle 1 This Regulation is developed to regulate the第一条为了规范化妆品生产经营活动，加强化妆OrderoftheStateCouncilofthePeoplesRepublicofChina(No.727)TheRegulationontheSupervisionandAdministrationofCosmetics,asadoptedatthe77thexecutivemeetingoftheStateCouncilonJanuary3,2020,isherebyissued,andshallcomeint

3、oforceonJanuary1,2021.Premier:LiKeqiangJune16,2020RegulationontheSupervisionandAdministrationofCosmeticsChapterIGeneralProvisions中华人民共和国国务院令（第727号）化妆品监督管理条例已经2020年1月3日国务院第77次常务会议通过，现予公布，自2021年1月1日起施行。总理李克强2020年6月16日化妆品监督管理条例第一章总则productionanddistributionofcosmetics,strengthenthesupervisionandadminis

4、trationofcosmetics,ensurethequalityandsafetyofcosmetics,safeguardconsumershealth,andpromotethehealthydevelopmentofthecosmeticsindustry.Article2WhoeverengagesintheproductionanddistributionaswellassupervisionandadministrationofcosmeticswithintheterritoryofthePeoplesRepublicofChinashallcomplywiththisRe

5、gulation.Article3ForthepurposeofthisRegulation,ttcosmeticsmeansthosedailyusedchemicalproductsappliedonthesurfaceofanypartsofthehumanbody,suchasskin,hair,nailsandlips,bywayofsmearing,sprayingorothersimilarmethodsforthepurposesofcleaning,protection,beautificationandmodification.Article 4 Thestateimple

6、mentsclassifiedadministrationofcosmeticsandcosmeticrawmaterialsaccordingtothedegreeofrisks.Cosmeticsaredividedintospecialcosmeticsandgeneralcosmetics.Thestateshallconductregistrationadministrationofspecialcosmeticsandconductrecordationadministrationofgeneralcosmetics.Cosmeticrawmaterialsshallbedivid

7、edintonewrawmaterialsandusedrawmaterials.Thestateconductsregistrationadministrationofnewcosmeticrawmaterialswithahighdegreeofrisks,andconductrecordationadministration品监督管理，保证化妆品质量安全，保障消费者健康，促进化妆品产业健康发展，制定本条例。第二条在中华人民共和国境内从事化妆品生产经营活动及其监督管理，应当遵守本条例。第三条本条例所称化妆品，是指以涂擦、喷洒或者其他类似方法，施用于皮肤、毛发、指甲、口唇等人体表面，以清洁、

8、保护、美化、修饰为目的的日用化学工业产品。第四条国家按照风险程度对化妆品、化妆品原料实行分类管理。化妆品分为特殊化妆品和普通化妆品。国家对特殊化妆品实行注册管理，对普通化妆品实行备案管理。化妆品原料分为新原料和已使用的原料。国家对风险程度较高的化妆品新原料实行注册管理，对其他化妆品新原料实行备案管理。ofothernewcosmeticrawmaterials.Article 5 ThedrugsupervisionandadministrationdepartmentoftheStateCouncilshalltakechargeofthesupervisionandadministrati

9、onofcosmeticsnationwide.TherelevantdepartmentsoftheStateCouncilshalltakechargeofthesupervisionandadministrationworkrelatedtocosmeticswithinthescopeoftheirrespectivefunctions.Thedepartmentsinchargeofdrugsupervisionandadministrationofthelocalpeoplesgovernmentatorabovethecountylevelshalltakechargeofthe

10、supervisionandadministrationofcosmeticswithintheirrespectiveadministrativeregions.Therelevantdepartmentsofthelocalpeoplesgovernmentsatorabovethecountylevelshalltakechargeofthesupervisionandadministrationworkrelatedtocosmeticswithinthescopeoftheirrespectivefunctions.Article 6 Cosmeticregistrantsandre

11、cordationentitiesshallberesponsibleforthequalityandsafetyofandtheefficacyclaimsforcosmetics.Cosmeticmanufacturersanddistributorsshall,inaccordancewithlaws,regulations,compulsorynationalstandards,andtechnicalspecifications,engageinproductionanddistributionactivities,strengthenadministration,andbehone

12、standself-regulatoryloensurethequalityandsafetyofcosmetics.Article 7 Cosmeticindustryassociationsshallstrengthenindustryself-regulation,superviseandguidetheproduction第五条国务院药品监督管理部门负责全国化妆品监督管理工作。国务院有关部门在各自职责范围内负责与化妆品有关的监督管理工作。县级以上地方人民政府负责药品监督管理的部门负责本行政区域的化妆品监督管理工作。县级以上地方人民政府有关部门在各自职责范围内负责与化妆品有关的监督管理工

13、作.第六条化妆品注册人、备案人对化妆品的质量安全和功效宣称负贵。化妆品生产经营者应当依照法律、法规、强制性国家标准、技术规范从事生产经营活动，加强管理，诚信自律，保证化妆品质量安全。第七条化妆品行业协会应当加强行业自律，督促引导化妆品生产经营者依法从事生产经营活动，推动行业anddistributionactivitiesengagedinbycosmeticmanufacturersanddistributorsaccordingtothelaw,andpromotethebuildingofintegrityintheindustry.诚信建设。Article 8 Consumerasso

14、ciationsandotherconsumerorganizationsshallconductsocialsupervisionagainstactivitiesdamagingthelawfulrightsandinterestsofconsumersinviolationofthisRegulation.Article 9 Thestateencouragesandsupportstheresearchandinnovationofcosmeticstosatisfyconsumerdemands,promotethebuildingofcosmeticbrands,andmaximi

15、zetheleadingroleofbrands.Thestateprotectsthelegitimaterightsandinterestsofentitiesandindividualsintheresearchandinnovationoncosmetics.Thestateencouragesandsupportscosmeticmanufacturersanddistributorsadoptionofadvancedtechnologiesandadvancedadministrationstandardstoimprovethequalityandsafetyofcosmeti

16、cs;andencouragesandsupportstheuseofmodemscientifictechnologiestoresearchanddevelopcosmeticsinconsiderationofChinastraditionaladvantageousprojectsandcharacteristicplantresources.Article 10 Thestatestrengthenstheinformationtechnologyconstructionforthesupervisionandadministrationofcosmetics,enhancesthe

17、levelofonlinegovernmentaffairsservices,facilitatesthehandlingofcosmeticsadministrativelicensingandrecordation,andpromotesthesharingofsupervisionandadministrationinformation.第八条消费者协会和其他消费者组织对违反本条例规定损害消费者合法权益的行为，依法进行社会监督。第九条国家鼓励和支持开展化妆品研究、创新，满足消费者需求，推进化妆品品牌建设，发挥品牌引领作用。国家保护单位和个人开展化妆品研究、创新的合法权益。国家鼓励和支持化

18、妆品生产经营者采用先进技术和先进管理规范，提高化妆品质量安全水平；鼓励和支持运用现代科学技术，结合我国传统优势项目和特色植物资源研究开发化妆品。第十条国家加强化妆品监督管理信息化建设，提高在线政务服务水平，为办理化妆品行政许可、备案提供便利，推进监督管理信息共享。第二章原料与产品ChapterIIRawMaterialsandProductsArticle 11 ThenaturalorartificialrawmaterialsusedforcosmeticsforthefirsttimewithintheterritoryofChinaarenewcosmeticrawmaterials.

19、Newcosmeticrawmaterialswithfunctionsofanti-corrosion,sunprotection,coloring,haircoloring,freckleremovalandskinwhiteningmaynotbeusedunlesstheyhavebeenregisteredwiththedrugsupervisionandadministrationdepartmentoftheStateCouncil;andothernewcosmeticrawmaterialsshallbefiledwiththedrugsupervisionandadmini

20、strationdepartmentoftheStateCouncilbeforebeingused.ThedrugsupervisionandadministrationdepartmentoftheStateCouncilmay,accordingtothedevelopmentofscientificresearch,adjustthescopeofnewcosmeticrawmaterialssubjecttoregistrationadministration,whichshallbeimplementeduponapprovalbytheStateCouncil.Article 1

21、2 Whoeverappliesfortheregistrationofnewcosmeticrawmaterialsorundergoestherecordationformalitiesfornewcosmeticrawmaterialsshallsubmitthefollowingmaterials:(1) Thename,addressandcontactinformationoftheregistrationapplicantorrecordationentity.(2) Researchanddevelopmentreportonthenewrawmaterials.(3) Res

22、earchmaterialsonthepreparationprocessfor,thestabilityofandthequalitycontrolstandardsfornewraw第H条在我国境内首次使用于化妆品的天然或者人工原料为化妆品新原料。具有防腐、防晒、着色、染发、祛斑美白功能的化妆品新原料，经国务院药品监督管理部门注册后方可使用：其他化妆品新原料应当在使用前向国务院药品监督管理部门备案。国务院药品监督管理部门可以根据科学研究的发展，调整实行注册管理的化妆品新原料的范围，经国务院批准后实施。第十二条申请化妆品新原料注册或者进行化妆品新原料备案，应当提交下列资料：（一）注册申请人、

23、备案人的名称、地址、联系方式；（二）新原料研制报告；（三）新原料的制备工艺、稳定性及其质量控制标准等研究资料；materials,amongothers.(4) Safetyassessmentmaterialsonnewrawmaterials.TheregistrationapplicantorrecordationentityshallberesponsiblefortheauthenticityandScientificityofthematerialssubmitted.Article13Thedrugsupervisionandadministrationdepartmentoft

24、heStateCouncilshalltransfertheapplicationmaterialstothetechnicalreviewinstitutionwithinthreeworkingdaysfromthedatewhenitacceptstheapplicationfortheregistrationofnewcosmeticrawmaterials.Thetechnicalreviewinstitutionshallcompletethetechnicalreviewwithin90workingdaysfromthedatewhenitreceivesapplication

25、materials,andsubmitthereviewopinionstothedrugsupervisionandadministrationdepartmentoftheStateCouncil.ThedrugsupervisionandadministrationdepartmentoftheStateCouncilshallmakeadecisionwithin20workingdaysfromthedatewhenitreceivesthereviewopinions.Iftheapplicationmeetstherequirements,registrationshallbeg

26、rantedandaregistrationcertificatefornewcosmeticrawmaterialsshallbeissued;andiftheapplicationfailstomeettherequirements,noregistrationshallbegranted,andthereasonsthereforshallbegiveninwriting.Recordationformalitiesarecompletedonceanentityundergoingtherecordationformalitiesfornewcosmeticrawmaterialssu

27、bmitstherecordationmaterialsasprescribedinthisRegulationthroughtheonlinegovernmentaffairsserviceplatformofthedrugsupervisionandadministration（四）新原料安全评估资料。注册申请人、备案人应当对所提交资料的真实性、科学性负责。第十三条国务院药品监督管理部门应当自受理化妆品新原料注册申请之日起3个工作日内将申请资料转交技术审评机构。技术审评机构应当自收到申请资料之日起90个工作日内完成技术审评，向国务院药品监督管理部门提交审评意见。国务院药品监督管理部门应当自

28、收到审评意见之日起20个工作日内作出决定。对符合要求的，准予注册并发给化妆品新原料注册证；对不符合要求的，不予注册并书面说明理由。化妆品新原料备案人通过国务院药品监督管理部门在线政务服务平台提交本条例规定的备案资料后即完成备案。Thedrugsupen,isionandadministrationdepartmentoftheStateCouncilshall,withinfiveworkingdaysfromthedatewhentheregistrationofnewcosmeticrawmaterialsisgrantedandtherecordationentitysubmitsthe

29、recordationmaterials,issuetothepublictherelevantinformationonregistrationandrecordation.Article14Withinthreeyearsafterthenewcosmeticrawmaterialsregisteredandfiledareputintouse,thenewrawmaterialregistrantsandrecordationentitiesshallreporttothedrugsupervisionandadministrationdepartmentoftheStateCounci

30、ltheinformationontheuseandsafetyofnewrawmaterialseachyear.Forthenewcosmeticrawmaterialswithsafetyproblems,thedrugsupen,isionandadministrationdepartmentoftheStateCouncilshallcanceltheregistrationorrecordation.Thenewcosmeticrawmaterialsthatdonothaveanysafetyproblemduringthree-yearperiodshallbeincluded

31、inthecatalogueofcosmeticrawmaterialsthathavebeenputintousedevelopedbythedrugsupervisionandadministrationdepartmentoftheStateCouncil.Beforebeingincludedinthecatalogueofcosmeticrawmaterialsthathavebeenputintouse,thenewcosmeticrawmaterialsregisteredandfiledshallremainadministeredasnewcosmeticrawmateria

32、ls.Article 15 Thecatalogueofmaterialsprohibitedfrombeingusedforcosmeticsproductionshallbedevelopedandissuedbythedrugsupervisionandadministrationdepartmentofthe国务院药品监督管理部门应当自化妆品新原料准予注册之日起、备案人提交备案资料之日起5个工作日内向社会公布注册、备案有关信息。第十四条经注册、备案的化妆品新原料投入使用后3年内，新原料注册人、备案人应当每年向国务院药品监督管理部门报告新原料的使用和安全情况。对存在安全问题的化妆品新原料

33、，由国务院药品监督管理部门撤销注册或者取消备案。3年期满未发生安全问题的化妆品新原料，纳入国务院药品监督管理部门制定的已使用的化妆品原料目录。经注册、备案的化妆品新原料纳入已使用的化妆品原料目录前，仍然按照化妆品新原料进行管理。第十五条禁止用于化妆品生产的原料目录由国务院药品监督管理部门制定、公布。Article 16 Cosmeticsusedforhaircoloring,perming,freckleremovalandskinwhitening,sunscreening,andhairlossprevention,andcosmeticswithnewefficacyclaimsare

34、specialcosmetics.Cosmeticsotherthanspecialcosmeticsaregeneralcosmetics.ThedrugsupervisionandadministrationdepartmentoftheStateCouncilshalldevelopandissuethecosmeticclassificationrulesandcataloguesaccordingtotheefficacyclaimsforcosmetics,partstowhichcosmeticsapply,productdosageforms,andusersandotherf

35、actors.Article 17 SpecialcosmeticsmaynotbeproducedandimportedunlesstheyhavebeenregisteredwiththedrugsupervisionandadministrationdepartmentoftheStaleCouncil.Domesticallyproducedgeneralcosmeticsshallbefiledwiththedrugsupervisionandadministrationdepartmentsofthepeoplesgovernmentsoftheprovinces,autonomo

36、usregions,andmunicipalitiesdirectlyundertheCentralGovernmentattheplaceswheretherecordationentitiesarelocatedbeforetheyaremarketed.ImportedgeneralcosmeticsshallbefiledwiththedrugsupervisionandadministrationdepartmentoftheStateCouncilbeforeimport.Article 18 Acosmeticsregistrationapplicantorrecordation

37、entityshallmeetthefollowingconditions:第十六条用于染发、烫发、祛斑美白、防晒、防脱发的化妆品以及宣称新功效的化妆品为特殊化妆品。特殊化妆品以外的化妆品为普通化妆品。国务院药品监督管理部门根据化妆品的功效宣称、作用部位、产品剂型、使用人群等因素，制定、公布化妆品分类规则和分类目录。第十七条特殊化妆品经国务院药品监督管理部门注册后方可生产、进口。国产普通化妆品应当在上市销售前向备案人所在地省、自治区、直辖市人民政府药品监督管理部门备案。进口普通化妆品应当在进口前向国务院药品监督管理部门备案。第十八条化妆品注册申请人、备案人应当具备下列条件：(I)IIiSane

38、nterpriseorotherorganizationformedaccordingto(一)是依法设立的企业或者其他组织;thelaw.(2) Ithasthequalitymanagementsystemappropriatefortheproductstoberegistereduponrequestorfiled.(3) Ithasthecapabilitiestormonitoringandevaluatingtheadversereactionsofcosmetics.Article19Anapplicantfortheregistrationofspecialcosmetics

39、oranentityundergoingtherecordationformalitiesforgeneralcosmeticsshallsubmitthefollowingmaterials:(1) Thename,addressandcontactinformationoftheregistrationapplicantortherecordationentity.(2) Thename,addressandcontactinformationofthemanufacturer.(3) Productname.(4) Productformulaorallingredientsofthep

40、roduct.(5) Standardstowhichtheproductconforms.(6) Sampleproductlabel.(7) Productinspectionreport.（二）有与申请注册、进行备案的产品相适应的质量管理体系；（三）有化妆品不良反应监测与评价能力。第十九条申请特殊化妆品注册或者进行普通化妆品备案，应当提交下列资料：（一）注册申请人、备案人的名称、地址、联系方式；（二）生产企业的名称、地址、联系方式；（三）产品名称；（四）产品配方或者产品全成分：（五）产品执行的标准；（六）产品标签样稿；（七）产品检验报告；(8) Productsafetyassessme

41、ntmaterials.（八）产品安全评估资料。Wheretheregistrationapplicantappliesfortheregistrationofspecialcosmeticsforthefirsttimeortherecordationentityundergoestherecordationformalitiesforgeneralcosmeticsforthefirstlime,itshallsubmitthecertificationmaterialsprovingthatitmeetstheconditionsasprescribedinArticle18ofthis

42、Regulation.Whoeverappliesfortheregistrationofimportedspecialcosmeticsorundergoestheformalitiesforimportedgeneralcosmeticsshallsubmitthecertificationdocumentsprovingthatproductshavebeenmarketedinthecountry(region)wheretheyareproducedandthecertificationmaterialsprovingthattheoverseasmanufacturercompli

43、eswiththeGoodManufocturingPracticesforCosmetics;whereproductsareproducedexclusivelyforexporttoChina,andthecertificationmaterialsprovingthatProdUClShavebeenmarketedinthecountry(region)wheretheyareproducedcannotbesubmitted,thematerialsontherelevantresearchandexperimentationconductedforconsumersinChina

44、shallbesubmitted.TheregistrationapplicantorrecordationentityshallberesponsiblefortheauthenticityandScientificityofthematerialssubmitted.Article20ThedrugsupervisionandadministrationdepartmentoftheStateCouncilshallexaminetheapplicationsfortheregistrationofspecialcosmeticsundertheregistrationexaminatio

45、nproceduresfornewcosmeticrawmaterialsasprescribedinparagraph1ofArticle13ofthisRegulation.Iftheapplicationmeetstherequirements,registrationshallbegrantedandaregistrationcertificateforspecialcosmeticsshallbeissued;andiftheapplicationfailstomeettherequirements,注册申请人首次申请特殊化妆品注册或者备案人首次进行普通化妆品备案的，应当提交其符合本

46、条例第十八条规定条件的证明资料。申请进口特殊化妆品注册或者进行进口普通化妆品备案的，应当同时提交产品在生产国（地区）已经上市销售的证明文件以及境外生产企业符合化妆品生产质量管理规范的证明资料；专为向我国出口生产、无法提交产品在生产国（地区）已经上市销售的证明文件的，应当提交面向我国消费者开展的相关研究和试验的资料。注册申请人、备案人应当对所提交资料的真实性、科学性负责。第二十条国务院药品监督管理部门依照本条例第十三条第一款规定的化妆品新原料注册审查程序对特殊化妆品注册申请进行审查。对符合要求的，准予注册并发给特殊化妆品注册证：对不符合要求的，不予注册并书面说明理由。已经注册的特殊化妆品在生产工

47、艺、功效宣称等方面发生实质性变化的，注册人应当向原注册部门申请变更注册。noregistrationshallbegranted,andthereasonsthereforshallbegiveninwriting.Iftheregisteredspecialcosmeticshaveundergonesubstantialchangesintheproductiontechnology,efficacyclaims,amongothers,theregistrantshallapplylotheoriginalregistrationdepartmentforregistrationchan

48、ges.RecordationformalitiesarecompletedonceanentityundergoingrecordationformalitiesforgeneralcosmeticssubmitstherecordationmaterialsasprescribedinthisRegulationthroughtheonlinegovernmentaffairsserviceplatformof(hedrugsupervisionandadministrationdepartmentoftheStateCouncil.Thedrugsupervisionandadministrationdepartmentofthepeoplesgovernmentatorabovetheprovinciallevelshall,withinfiveworkingdaysfromthedatewhentheregistrationofspecialcosmeticsisgrantedortherecordationentitysubmitstherecordationmaterials,issuetothepublictherelevantinformationonregistrationandrecordation.Articl