【中英文对照版】化妆品抽样检验管理办法（2023）.docx

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1、国家药监局关于发布化妆品 抽样检验管理办法的公告（国家药品监督管理局公告 2023年第5号）为加强化妆品监督管理，规范 化妆品抽样检验工作，根据 化妆品监督管理条例化 妆品生产经营监督管理办法 等法规、规章，国家药监局组 织制定了化妆品抽样检验管 理办法，现予公布，自2023 年3月1日起施行。国家药监局关于发布化妆品抽样检验管理办法的公告AnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheMeasuresfortheAdministrationofSamplingInspectionofCosmetics【制定机

2、关】国家药品监督管理局【发文字号】国家药品监督管理局公告2023年第5号【公布日期】2023.01.11【施行日期】2023.03.01【效力位阶】部门规范性文件【法规类别】卫生综合规定Issuingauthority：OtherInslitulions,Others.AIIAdministrations(others),SlateDrugSupervision&AdministrationBureauDocumentNumber：AnnouncementNo.52023of(heNationalMedicalProductsAdministrationDateissued：01-11-202

3、3EfTectivedatet03-01-20231.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw：HealthandSanitationAnnouncementoftheNationalMedicalProductsAdministrationonIssuingtheMeasuresfortheAdministrationofSamplingInspectionofCosmetics(AnnouncementNo.52023oftheNationalMedicalProductsAdministration)Forthepu

4、rposesofstrengtheningthesupervisionandadministrationofcosmetics,andstandardizingsamplinginspectionofcosmetics,inaccordancewiththeRegulationontheSupervisionandAdministrationofCosmetics,theMeasuresfortheSupervisionandAdministrationofProductionandDistributionofCosmetics,andotherlawsandregulations,theNa

5、tionalMedicalProductsAdministrationhasorganizedthedevelopmentoftheMeasuresfortheAdministrationofSamplingInspectionofCosmetics,whichareherebyissuedandshallcomeintoforceonMarch1,2023.特此公告。Annex:MeasuresfortheAdministrationofSamplingInspectionofCosmeticsNationalMedicalProductsAdministrationJanuary11,20

6、23AnnexMeasuresfortheAdministrationSamplingInspectionofCosmeticsChapterIGeneralProvisions国家药监局2023年1月11日附件of化妆品抽样检验管理办法第一章总则Article1Forthepurposesofstrengtheningthesupervisionandadministrationofcosmetics,andstandardizingsamplinginspectionofcosmetics,inaccordancewiththeRegulationontheSupervisionandAd

7、ministrationofCosmetics,theMeasuresfortheSupervisionandAdministrationofProductionandDistributionofCosmetics,andotherlawsandregulations,theseMeasuresaredeveloped.Article2WithintheterritoryofthePeople,sRepublicofChina,thedepartmentresponsibleformedicalproductssupervisionandadministrationshallorganizet

8、heimplementationofsamplinginspectionofcosmeticsaccordingtotheseMeasures.附件：化妆品抽样检验管理办 法第一条为了加强化妆 品监督管理，规范化妆品抽样 检验工作，根据化妆品监督 管理条例化妆品生产经营 监督管理办法等法规、规章, 制定本办法。第二条在中华人民共 和国境内，负责药品监督管理 的部门组织实施化妆品抽样 检验工作，应当遵守本办法。第三条负责药品监督 管理的部门应当遵循科学、规 范、合法、公正的原则，组织 实施化妆品抽样检验工作，加 强对抽样、检验、异议审查和 复检、核查处置及信息公开的 全过程管理。Article3

9、Thedepartmentresponsibleformedicalproductssupervisionandadministrationshallfollowtheprinciplesofscience,standardization,legalityandjustice,organizetheimplementationofsamplinginspectionofcosmetics,andstrengthentheadministrationduringthewholeprocessofsampling,inspection,objectionreviewandre-inspection

10、,XzorifinQtinnandHicnncalanrlinfnrmatinndisclosure.Article4TheNationalMedicalProductsAdministration(uNMPAn)shallorganizeandcarryoutnationalsamplinginspectionofcosmeticseveryyear.Themedicalproductsadministrationsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentshallorgan

11、izesamplinginspectionofcosmeticswithintheirrespectiveadministrativeregionseveryyear,andundertakethetaskofnationalsamplinginspectionofcosmeticsinaccordancewiththerequirementsoftheNMPA.Thedepartmentresponsibleformedicalproductssupervisionandadministrationatthedistrictedcityorcountylevelshall,according

12、totheworkneeds,organizesamplinginspectionofcosmeticswithinitsownadministrativeregion,andundertakethetaskofsamplinginspectionofcosmeticsaccordingtotherequirementsofthedepartmentresponsibleformedicalproductssupervisionandadministrationatanexthigherlevel.Article5Cosmeticmanufacturersanddistributorsshal

13、lacceptsamplinginspectionofcosmeticsorganizedbythedepartmentsresponsibleformedicalproductssupervisionandadministrationinaccordancewiththelaw,andshallneitherinterferewith,hinderorrefusethesamplinginspectionwork,norprovidefalseinformation.第四条国家药品监督 管理局每年组织开展国家化 妆品抽样检验工作。省、自治区、直辖市药品监督 管理部门每年组织开展本行 政区域内

14、的化妆品抽样检验 工作，并按照国家药品监督管 理局的要求，承担国家化妆品 抽样检验任务。设区的市级、县级负责药品监 督管理的部门根据工作需要， 组织开展本行政区域内的化 妆品抽样检验工作，并按照上 级负责药品监督管理的部门 的要求，承担化妆品抽样检验 任务。第五条化妆品生产经 营者应当依法接受负责药品 监督管理的部门组织实施的 化妆品抽样检验，不得干扰、 阻碍或者拒绝抽样检验工作， 不得提供虚假信息。第六条化妆品抽样应 当支付抽取样品的费用。抽样 裕哈昕雪弗用垢昭国家有辛Article6Costsoftakingsamplesshallbepaidforcosmeticssampling.Ex

15、pensesrequiredforsamplinginspectionshallbeincludedinthegovernmentbudgetinaccordancewiththerelevantrulesofthestate.Article7TheNMPAshallberesponsibleforestablishinganinformationsystemfornationalsamplinginspectionofcosmeticsandstrengtheningtheinformationconstructionofsamplinginspectionofcosmetics.Chapt

16、erIlPlanningArticle8Thedepartmentsresponsibleformedicalproductssupervisionandadministrationthatorganizesamplinginspection(hereinafterreferredtoas“samplinginspectiondepartments)shallpreparesamplinginspectionplans.TheNMPAshalldevelopanannualplanfornationalsamplinginspectionofcosmeticseveryyear.Themedi

17、calproductsadministrationsofprovinces,autonomousregionsandmunicipalitiesdirectlyundertheCentralGovernmentshall,inaccordancewiththeannualplanfornationalsamplinginspectionofcosmetics,developimplementationplansfortheirrespectiveadministrativeregions.规定列入政府预算。第七条国家药品监督 管理局负责建立国家化妆品 抽样检验信息系统，加强化妆 品抽样检验信息

18、化建设。第二章计划制定第八条组织抽样检验 的负责药品监督管理的部门 （以下简称“组织抽检部门”） 应当制定抽样检验计划。国家药品监督管理局应当每 年制定年度国家化妆品抽样 检验计划。省、自治区、直辖 市药品监督管理部门应当按 照年度国家化妆品抽样检验 计划，制定本行政区域的实施 方案。省、自治区、直辖市药品监督 管理部门应当每年制定本行 政区域年度化妆品抽样检验 计划。省级化妆品抽样检验计 划应当与国家化妆品抽样检 验计划相互衔接，各有侧重， 扩大抽样覆盖面，避免重复抽 样。Themedicalproductsadministrationsofprovinces,autonomousregio

19、nsandmunicipalitiesdirectlyundertheCentralGovernmentshall,onanannualbasis,prepareannualplansforsamplinginspectionofcosmeticswithintheiradministrativeregions.Theprovincialplansforsamplinginspectionofcosmeticsshallbemutuallyconnectedwiththenationalplanforsamplinginspectionofcosmetics,havetheirownfocus

20、,expandthecoverageofsampling,andavoidrepeatedsampling.Thedepartmentresponsibleformedicalproductssupervisionandadministrationatthedistrictedcityorcountylevelshall,accordingtoitsworkneeds,developplansforsamplinginspectionofcosmeticsinitsadministrativeregion.Article9Aplanforsamplinginspectionofcosmetic

21、sshallincludethefollowingcontents:(1) Thecategoriessubjecttosampling.(2) Therequirementsforsamplingareas,links,premises,quantities,timelimitandothersamplingwork.(3) Therequirementsfortheitemsandmethodsofinspections,judgmentbasis,timelimitofinspection,andotherinspectionwork.(4) Themethodandtimelimitf

22、orsubmittinginspectionreports.(5) Therequirementsfortheverificationanddisposalofproductswhoseinspectionconclusionisnotinconformitywiththeprovisions.(6) Otherworkrequirements.Article10Samplinginspectionofcosmeticsshallfocusonthefollowingproducts:(1) Childrenscosmeticsandspecialcosmetics.(2) Cosmetics

23、usingnewrawmaterials.设区的市级、县级负责药品监 督管理的部门根据工作需要， 制定本行政区域化妆品抽样 检验计划。第九条化妆品抽样检 验计划应当包括下列内容：（一）抽样的品类;（二）抽样区域、环节、场所、 数量、时限等抽样工作要求；（三）检验项目、检验方法、 判定依据、检验时限等检验工 作要求；（四）检验报告的报送方式和 时限；（五）对检验结论为不符合规 定产品的核查处置要求；（六）其他工作要求。第十条化妆品抽样检 验应当重点关注下列产品：（一）儿童化妆品和特殊化妆（二）使用新原料的化妆品;（三）监督检查、案件查办、不良反应监测、安全风险监(3) Cosmeticsinwh

24、ichmanyproblemsarefoundinsupervisionandinspection,caseinctir+innandhandlinnadarcoreactionmonitoring,safetyriskmonitoring,complaintsandtip-off,monitoringofpublicopinionsandotherregulatorywork.(4) Cosmeticswithrelativelyhighrateofdisqualificationinprevioussamplinginspections.(5) Cosmeticswithwidecircu

25、lationandhighfrequencyofuse.(6) Otherproductswithrelativelyhighsafetyrisks.ChapterIIISamplingArticle 11 Thesamplingworkshallinsistontheprincipleofcombiningproblemorientation,extensivecoverage,supervisionandinspectionwithsamplinginspection.Article 12 Thedepartmentresponsibleformedicalproductssupervis

26、ionandadministrationmayconductsamplingbyitself,orentrustthesamplingtasktoentitieswithcorrespondingcapabilities.Wheresamplingisentrusted,thedepartmentresponsibleformedicalproductssupervisionandadministrationshallinspectandevaluatethesamplingworkoftheentityundertakingthesamplingtask.测、投诉举报、舆情监测等监 管工作中

27、发现问题较多的；（四）既往抽样检验不合格率 较高的；（五）流通范围广、使用频次 高的；（六）其他安全风险较高的产 品O第三章抽样第H 条抽样工作应 当坚持问题导向、广泛覆盖、 监督检查与抽样检验相结合 的原则。第十二条负责药品监 督管理的部门可以自行抽样， 也可以委托具有相应能力的 单位承担抽样任务。委托抽样的，负责药品监督管 理的部门应当对承担抽样任 务单位的抽样工作进行检查 评估。第十三条抽样单位应 当按照化妆品抽样检验计划 制定具体的抽样工作实施方 案，组织对抽样人员进行培 训，保证抽样工作质量。抽样 人员应当熟悉抽样工作相关 的化妆品专业知识和法律法Article 13 Asampli

28、ngentityshalldevelopspecificimplementationplansforthesamplingworkinaccordancewithplansforsamplinginspectionofcosmetics,organizetrainingforsamplingpersonnel,andensurethequalityofthesamplingwork.SamplingpersonnelshallbefamiliarwiththenrnfoccinnalUnnuzIodriQanrlIqqanrlregulationsoncosmeticsrelatedtosam

29、plingwork.Samplingpersonnelshallnotundertaketheinspectionworkofsamplestakenbythem.Article 14 Samplingisdividedintoon-sitesamplingandonlinesampling.Samplingentitiesandpersonnelshallnotnotifycosmeticproducersordistributorsinadvancebeforesampling.Thereshallbenotlessthantwosamplingpersonnelinasampling.D

30、uringon-sitesampling,samplingpersonnelshallproducethesamplingworkcertificationdocumentstothemanufacturersanddistributorsofcosmeticssubjecttosampling.Theonlinesamplingshallbeconductedbysimulatingtheonlineshoppingprocess,andsamplingpersonnelshallnotnotifymanufacturersanddistributorsofcosmeticssubjectt

31、osamplingofthepurchasepurpose.Article 15 Samplingpersonnelshallnotconductanyofthefollowingactsduringthesamplingprocess:(1) Unsealingorreplacingasamplewithoutauthorizationafterthesampleissealed.(2) Disclosingthetradesecretsofmanufacturersanddistributorsofcosmeticssubjecttosampling.(3) Otheractsaffect

32、ingthefairnessofsampling.规。抽样人员不得承担其抽取样 品的检验工作。第十四条抽样分为现 场抽样和网络抽样。抽样单位和人员抽样前不得 提前告知化妆品生产经营者。抽样时，抽样人员不得少于2 人。现场抽样时抽样人员应当向 被抽样化妆品生产经营者出 示抽样工作证明文件。网络抽 样应当模拟网络购物流程进 行，抽样人员不得告知被抽样 化妆品生产经营者购买目的。第十五条抽样人员在 抽样过程中不得有下列行为：（一）样品签封后擅自拆封或 者更换样品；（二）泄露被抽样化妆品生产 经营者的商业秘密；（三）其他影响抽样公正性的 行为。第十六条抽样前，抽样 人员应当对被抽样化妆品生 产经昔者的

33、市场半休皆汨讦Article 16 Beforeasampling,samplingpersonnelshallconductnecessaryinformationcheckingofthemarketentityregistrationcertificate,cosmeticproductionlicense,cosmeticlabel,etc.ofthemanufacturersanddistributorsofcosmeticssubjecttosampling;andalsochecktheestablishmentandimplementationofthepurchaseinsp

34、ectionrecordsystemduringon-sitesamplingofbusinesslinks,ifnecessary.Article 17 Where,insampling,cosmeticssuspectedoffallingunderthefollowingcircumstancesarefoundtobeabnormalinsampling,thesamplingentityshallfileacaseforpreliminaryinvestigationorreporttheproblemcluestothecompetentdepartmentresponsiblef

35、ormedicalproductssupervisionandadministrationaccordingtothelaw:(1) Specialcosmeticsthathavenotbeenregisteredorordinarycosmeticsforwhichrecordationformalitieshavenotbeenundergoneformarketingorimport.(2) Expiringtheperiodofuse.(3) WithoutlabelinChinese.(4) Indicatingprohibitedcontentsinthelabel.(5) Ot

36、hercosmeticssuspectedofviolatinglaws.Exceptunderthecircumstancesspecifiedinitem(2)oftheprecedingparagraph,thesamplingdepartmentmaycontinuetoconductsamplingofproductswithabnormalsamplingconditionsifitdeemsitnecessary.明、化妆品生产许可证、化妆 品标签等进行必要的信息核 对；经营环节现场抽样，必要 时还需查看进货查验记录制 度建立和执行情况。第十七条抽样中，发现 涉嫌存在以下情形的化

37、妆品， 属于抽样异常情况，抽样单位 应当依法立案调查或者将问 题线索依法通报具有管辖权 的负责药品监督管理的部门：（一）未经注册的特殊化妆品 或者未备案上市销售、进口的 普通化妆品；（二）超过使用期限；（三）无中文标签；（四）标签标注禁止标注的内容；（五）其他涉嫌违法的化妆 品O除前款第（二）项规定的情形 外，对存在抽样异常情况的产 品，抽样部门认为必要的，可 以继续抽样。第十八条化妆品抽样 裕蛤中的样品会为裕哈桂MArticle 18 Samplesinsamplinginspectionofcosmeticsaredividedintosamplesforinspectionandback

38、upsamplesforre-inspection.Inprinciple,thesamplingquantityshallmeettheminimumdemandforinspectionandre-inspection.Foron-sitesampling,samplingpersonnelshallrandomlydrawsamplesfromproductstobesoldbymanufacturersanddistributorsofcosmeticssubjecttosampling,Otherthanfromsamplesprovidedbymanufacturersanddis

39、tributorsofcosmeticssubjecttosampling.Samplingpersonnelshallkeepreceiptsforpurchaseofsamples,andifnecessary,keepevidenceonthesamplingsite,storageenvironmentandsampleinformationbytakingphotosorvideorecordings.Foronlinesampling,samplingpersonnelshallrecordtheregistrationaccount,paymentaccount,delivery

40、address,contactmethodandotherinformationonthesamplepurchased,andrecordtheinformationonmanufacturersanddistributorsofcosmeticssubjecttosampling,thewebsitefromwhichthesampleispurchased,theinformationdisplayedonthewebsiteofthesample,aswellasorderinformationandpaymentrecordsbymeansofscreenshot,photoorvi

41、deo.Afterreceivingasample,thesamplingpersonnelshallcheckthedeliverypackaginginformation,samplepackaging,etc.,andrecordtheunpackingprocessbytakingphotosorvideos.Article 19 Underanyofthefollowingcircumstances,samplingshallnotbeallowedinprinciple:(1)Theproductsareforexportonly.和复检备份样品。抽样数量原 则上应当满足检验和复检

42、工 作的最少需求量。现场抽样的，抽样人员应当从 被抽样化妆品生产经营者待 销售的产品中随机抽取样品， 不得由被抽样化妆品生产经 营者自行选择提供。抽样人员 应当保存购买样品的票据，必 要时对抽样场所、贮存环境、 样品信息等通过拍照或者录 像等方式留存证据。网络抽样的，抽样人员应当记 录购买样品的注册账号、付款 账户、收货地址、联系方式等 信息，并通过截图、拍照或者 录像等方式记录被抽样化妆 品生产经营者信息、样品购买 网址、样品网页展示信息，以 及订单信息、支付记录等。抽 样人员收到样品后，应当对递 送包装信息、样品包装等进行 查验，并通过拍照或者录像等 方式记录拆封过程。第十九条有下列情形

43、之一的，原则上不予抽样：（一）产品仅供出口；（一）声M已开打妗止破指ThAnrdcthavhAACnanaCLdamagedorcontaminated,whichmayaffecttheinspectionresults.(3) Theremainingservicelifeofaproductislessthansixmonths,exceptwhentheservicelifeoftheproductislessthansixmonths.(4) Othercircumstancesnotsubjecttosampling.Article20Samplingpersonnelshalla

44、dopteffectivemeasurestopreventunpackingandsealthesampleforinspectionandbackupsampleforre-inspectionrespectively.Aftersealingasample,theappearanceandstatusofthesampleshallbeabletobecheckedwithoutunsealing.Article21Samplingpersonnelshallusestandardizedsamplingdocumentstorecordsamplinginformationinacle

45、ar,completeandaccuratemanner.Theretentionperiodofsampledocumentsshallnotbelessthantwoyears.或者受到污染，可能影响检验 结果；（三）产品剩余使用期限不足 6个月，产品使用期限小于6 个月的除外；（四）其他不予抽样的情形。第二十条抽样人员应 当采取有效的防拆封措施，对 检验样品和复检备份样品分 别封样。封样后应当可以在不 拆封的情况下，查看样品外 观、状态等情况。第二十一条抽样人员 应当使用规范的抽样文书，清 晰、完整、准确地记录抽样信 息。抽样文书保存期限不得少 于2年。现场抽样的，抽样人员应当告 知被抽

46、样化妆品生产经营者 依法享有的权利和应当承担 的义务。抽样人员和被抽样化 妆品生产经营者的负责人或 者相关人员应当在化妆品抽 样文书及抽样封签上以签字、 盖章等方式确认。被抽样化妆 品生产经营者负责人或者相 关人员对抽样过程有异议拒 绝确认的，抽样人员应当现场 取证，在化妆品抽样文书上注 明并签字。Inthecaseofon-sitesampling,samplingpersonnelshallnotifymanufacturersanddistributorsofcosmeticssubjecttosamplingoftheirrightsenjoyedaccordingtothelawan

47、dobligationstobeassumed.Samplingpersonnelandresponsiblepersonsorrelevantpersonnelofmanufacturersanddistributorsofcosmeticssubjecttosamplingshallconfirmthesamplingdocumentsandthesamplingsealsbyaffixingsealsandsignatures.Whereresponsiblepersonsorrelevantpersonnelofmanufacturersanddistributorsofcosmeti

48、cssubjecttosamplinghaveobjectionstothesamplingprocessandrefusetoconductconfirmation,samplingnrcnnnlchlltkidnnnnthCeC十andindicateonandaffixsignaturestothecosmeticssamplingdocument.Foronlinesampling,samplingpersonnelshallaffixsignaturesandofficialsealoftheentitytothesamplingdocumentandthesamplingseal,andsignaturesorsealsofmanufacturersanddistributorsofcosmeticssubjecttosamplingarenotrequiredtobeaffixed.Article22Foron-sitesampling,paymentofsamplefeesisdividedintoon-sitesettlementandoff-sitesettlement.Incaseofon-site