【中英文对照版】保健食品新功能及产品技术评价实施细则(试行).docx

市场监管总局关于公布保健食品 新功能及产品技术评价实施细则 （试行）的公告（国家市场监督管理总局公告2023 年第37号）保健食品新功能及产品技术评价 实施细则（试行）已经2023年6 月15日市场监管总局第11次局务 会议通过，现予公告，自公布之日 起施行。保健食品新功能及产品技术评价实施细则(试行)DetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTrialImplementation)制定机关：国家市场监督管理总局发文字号：国家市场监督管理总局公告2023年第37号公布日期：2023.08.13施行日期：2023.08.13效力位阶：部门规范性文件法规类别：质量综合规定IssuingAuthority:StateAdministrationforMarketRegulationDocumentNumber：AnnouncementNo.372023oftheStateAdministrationforMarketRegulationDateIssued：08-13-2023EffectiveDale:08-13-20231.evelofAuthority：DepartmentalRegulatoryDocumentsAreaofLaw：GeneralProvisionsonQualityAnnouncementoftheStateAdministrationforMarketRegulationonIssuingtheDetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTriaIImplementation)(AnnouncementNo.372023oftheStateAdministrationforMarketReguation)TheAnnouncementoftheStateAdministrationforMarketRegulationonIssuingtheDetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTrialImplementation),asadoptedatthe11thexecutivemeetingoftheStateAdministrationforMarketRegulationonJune15,2023,areherebyissued,andshallcomeintoforceonthedateofissuance.市场监管总局StateAdministrationforMarketRegulationAugust13,20232023年8月13日DetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTriaIImplementation)保健食品新功能及产品技术评价实施细则（试行）ChapterIGeneralProvisions第一章总则Article1Forthepurposesofregulatingthenewfunctionsofdietarysupplementsandthetechnicalevaluationoftheproducts,theseDetailedRulesaredevelopedinaccordancewiththeFoodSafetyLawofthePeople'sRepublicofChina,theMeasuresfortheAdministrationoftheCatalogueofRawMaterialsofDietarySupplementsandtheCatalogueofHealthFunctions,theMeasuresfortheAdministrationoftheRegistrationandRecordationofDietarySupplements,andotherlawsandregulations.Article2Thenewfunctionsofdietarysupplementsandthetechnicalevaluationoftheproductsshallbedesignedtomeettheneedsofconsumersforhealthfulproductsandfollowtheprinciplesofpromotinghealth,beingscientific,reasonable,authentic,objective,andfair.Article3Anyentityorindividual(uproposer)thatconductsrelevantresearchmayindividuallyorjointlyputforwardsuggestionsonthenewfunctionstotheCenterforFoodEvaluationoftheStateAdministrationforMarketRegulation(uCenterforFood第一条为了规范保健食品新功能及产品的技术评价工作，根据中华人民共和国食品安全法保健食品原料目录与保健功能目录管理办法保健食品注册与备案管理办法等法律法规，制定本细则。第二条保健食品新功能及产品的技术评价工作，应当以满足消费者健康产品需求为宗旨，遵循促进健康、科学合理、真实可信、客观公正的原则。第三条任何单位或者个人（以下称建议人）在开展相关研究的基础上，可以单独或联合向国家市场监督管理总局食品审评中心（以下简称食品审评中心）提出新功能建议。Evaluationn).第四条 新功能建议纳入允许 保健食品声称的保健功能目录（以 下简称保健功能目录），应当通过 新功能研究和技术评价，并对新功 能保健食品开展上市后评价。Article4Ifanewfunctionisrecommendedtobeincludedinthecatalogueofhealthfunctionsasdescribedindietarysupplements("catalogueofhealthfunctions,)jresearchonthenewfunctionandtechnicalevaluationshallbecarriedout,andpost-marketingevaluationofadietarysupplementwiththenewfunctionshallbecarriedout.笫五条 建议人同步提出新功 能建议和对应的新功能保健食品注 册申请的，食品审评中心应当同步 接收，开展关联审评。第二章新功能研究Article5Ifaproposerputsforwardsuggestionsonanewfunctionandappliesforregistrationofadietarysupplementwiththenewfunction,theCenterforFoodEvaluationshallreceivebothofthemandcarryouttherelatedevaluation.ChapterIlResearchonNewFunctions第六条新功能定位应当明 确，分为补充膳食营养物质、维持 或改善机体健康状况、降低疾病发 生风险因素三类。Article6Newfunctionsshallhaveclearorientations,whicharedividedintothreecategories:supplementingdietarynutrients,maintainingorimprovingthebody,shealth,andreducingtheriskfactorsfortheonsetofdisease.第七条 新功能研究样品应当 是新研发的对应新功能的保健食 品，或经研究发现具有新功能的已 注册备案的保健食品。新功能研究 样品应当符合保健食品的安全性、 保健功能和质量可控性要求，具备 开展新功能保健食品技术评价条 件。Article7Thesamplesusedfornewfunctionresearchshallbenewlydevelopeddietarysupplementscorrespondingtonewfunctions,orregistereddietarysupplementswithnewfunctions,asshownbystudies.Thesamplesusedfornewfunctionresearchshallmeettherequirementsforthesafety,healthfunction,andqualitycontrollabilityofdietarysupplements,andhavetheconditionsforthetechnicalevaluationofdietarysupplementswithnewfunctions.Article8Forresearchonnewfunctions,researchshallbefullyconductedonthemethodsofevaluatingnewfunctionsandmethodologicaldemonstration.Beforeanewfunctionisproposed,itshallbeverifiedandevaluatedbyatleastonefoodinspectioninstitutionorclinicaltrialinstitutionthatmeetstherequirements.第八条新功能研究应当充分开展新功能评价方法研究和方法学论证。在提出新功能建议前，应当通过符合要求的至少1家食品检验机构或临床试验机构验证评价。Article9Theverificationandevaluationinstitutionproposedforanewfunctionshallbeselectedfromthefoodinspectioninstitutionsorclinicaltrialinstitutionsthatmeettherequirements,andtheverificationandevaluationtestsshallcomplywiththerelevantprovisionsondietarysupplementtestsandinspectionmanagement.笫九条新功能建议的验证评价机构应当在符合要求的食品检验机构或临床试验机构中选取，验证评价试验应当符合保健食品试验和检验管理相关规定。ChapterIIIMaterialReception第三章材料接收Article10Whenputtingforwardsuggestionsonanewfunction,theproposershallprovideproject-wide,clear,andcompletetechnicalevaluationm