【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

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1、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

2、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：GeneralPr

3、ovisionsonQualityAnnouncementoftheStateAdministrationforMarketRegulationonIssuingtheDetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTriaIImplementation)(AnnouncementNo.372023oftheStateAdministrationforMarketReguation)TheAnnouncementoftheStateAdministrationforMa

4、rketRegulationonIssuingtheDetailedRulesforNewFunctionsofDietarySupplementsandTechnicalEvaluationoftheProducts(ForTrialImplementation),asadoptedatthe11thexecutivemeetingoftheStateAdministrationforMarketRegulationonJune15,2023,areherebyissued,andshallcomeintoforceonthedateofissuance.市场监管总局StateAdminis

5、trationforMarketRegulationAugust13,20232023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Article1Forthepurposesofregulatingthenewfunctionsofdietarysupplementsandthetechnicalevaluati

6、onoftheproducts,theseDetailedRulesaredevelopedinaccordancewiththeFoodSafetyLawofthePeoplesRepublicofChina,theMeasuresfortheAdministrationoftheCatalogueofRawMaterialsofDietarySupplementsandtheCatalogueofHealthFunctions,theMeasuresfortheAdministrationoftheRegistrationandRecordationofDietarySupplements

7、,andotherlawsandregulations.Article2Thenewfunctionsofdietarysupplementsandthetechnicalevaluationoftheproductsshallbedesignedtomeettheneedsofconsumersforhealthfulproductsandfollowtheprinciplesofpromotinghealth,beingscientific,reasonable,authentic,objective,andfair.Article3Anyentityorindividual(upropo

8、ser)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

9、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(

10、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Article5Ifaproposerputsforwardsuggestionsonanewfunctionandap

11、pliesforregistrationofadietarysupplementwiththenewfunction,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,whicharedividedintothreecategor

12、ies: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。Article7Thesamplesusedfornewfunctionresearchshallbenewlydevelopeddietary

13、supplementscorrespondingtonewfunctions,orregistereddietarysupplementswithnewfunctions,asshownbystudies.Thesamplesusedfornewfunctionresearchshallmeettherequirementsforthesafety,healthfunction,andqualitycontrollabilityofdietarysupplements,andhavetheconditionsforthetechnicalevaluationofdietarysupplemen

14、tswithnewfunctions.Article8Forresearchonnewfunctions,researchshallbefullyconductedonthemethodsofevaluatingnewfunctionsandmethodologicaldemonstration.Beforeanewfunctionisproposed,itshallbeverifiedandevaluatedbyatleastonefoodinspectioninstitutionorclinicaltrialinstitutionthatmeetstherequirements.第八条新功

15、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,andtheverificationandevaluationtestsshallcomplywiththerelevantpro

16、visionsondietarysupplementtestsandinspectionmanagement.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,andcompletetechnicalevaluationmaterialsandelectron

17、ictextsasrequiredbytheprojectofsuggestionsonthenewfunction,andberesponsiblefortheauthenticityofthesubmittedmaterials.PleaserefertotheAttachmentfortheprojectrequirementsofproposedmaterialsforfunctions.new第十条建议人提交新功能建议时，应当按照新功能建议项目要求提供全项目、清晰完整的技术评价材料及电子文本，并对提交材料的真实性负责。新功能建议材料项目要求见附表。for new theapplica

18、tion materials in accordance with the relevant provisions on the registration management of dietary supplements, and the applicants qualifications shall meet the requirements.Whensubmittinganapplicationregistrationofdietarysupplementswithfunctions,anapplicantshallsubmit申请人提交新功能保健食品注册申请时，应当按照保健食品注册管理

19、相关规定提交申请材料，申请人资质应当符合要求。Article 11 In addition to the contents relating to the catalogue of functions that must be disclosed, the proposer shall mark and specify the information on trade secrets and intellectual property on a case-by-case basis, and explicitly agree to the contents to be disclosed.第十

20、一条除必须公开的功能 目录相关内容外，建议人应当逐项 标注和具体说明涉及商业秘密和知 识产权等情况，并明确同意公开的 内容。Article 12 After receiving the proposed materials about new functions and the application materials for corresponding dietary supplements with new functions registration, the Center for Food Evaluation shall issue a receipt that meets the

21、 requirements and organize the technical evaluation in a timely manner; those that do not meet the requirements shall not be accepted.第十二条食品审评中心接收 新功能建议材料、对应的新功能保 健食品注册申请材料后，符合要求 的出具接收凭证，及时组织技术评 价；不符合要求的，不予接收。Chapter IV Technical Evaluation第四章技术评价Article 13 The Center for Food Evaluation shall organ

22、ize a technical evaluation of the following contents of the proposed materials for new functions according to the key points of technical evaluation in the attachment:第十三条食品审评中心按照 附表中的技术评价要点组织对新功 能建议材料的下列内容开展技术评 价：(1) the name, explanation, mechanism, and basis of the health function;（一）保健功能名称、解释、机理

23、 以及依据；(2) the research report on the health function, including an analysis of the peoples demand for the health function, an analysis of health function and body health effects and an overview, the basis of health functionothertesting,scopeofapplication,andrelatedscientificresearchmaterials.（二）保健功能

24、研究报告，包括保健功能的人群健康需求分析，保健功能与机体健康效应的分析以及综述，保健功能试验的原理依据、适用范围，以及其他相关科学研究资料；（三）保健功能评价方法和判定标 准，以及评价方法和判定标准的验 证评价资料；（四）相同或者类似功能在国内外 的研究应用情况；（五）有关科学文献依据以及其他 材料。第十四条 同步提交新功能建 议和对应的新功能保健食品注册申 请的，食品审评中心开展关联审 评。材料符合要求的，开展现场核 查，并根据需要邀请建议人对新功 能研究进行技术交流。第十五条经技术评价，食品 审评中心对新功能建议作出“建议 纳入保健功能目录”或“不符合保 健功能目录纳入条件”的技术评价 结

25、论。第十六条符合下列要求的， 新功能建议技术评价结论为“建议 纳入保健功能目录”：（一）建议材料项目完整;(3) theevaluationmethodsandcriteriaforthehealthfunction,andtheverificationandevaluationdataontheevaluationmethodsandcriteria;(4) researchonandapplicationofthesameorsimilarfunctionsathomeandabroad;and(5) thebasisofrelevantscientificdocumentsandothe

26、rmaterials.Article 14 Ifsuggestionsonanewfunctionandanapplicationforregistrationofadietarysupplementwiththenewfunctionaresubmittedsimultaneously,theCenterforFoodEvaluationshallcarryouttherelatedevaluation.Ifthematerialsmeettherequirements,anon-siteverificationshallbecarriedout,andtheproposershallbei

27、nvitedtoconducttechnicalexchangesonresearchonthenewfunctionasneeded.Article 15 Afterthetechnicalevaluation,theCenterforFoodEvaluationshallreachaconclusiononthetechnicalevaluationonsuggestionsonthenewfunction,namely“recommendingincludingitinthecatalogueofhealthfunctionsornotmeetingtheconditionsforinc

28、lusioninthecatalogueofhealthfunctions*.Article 16 Ifthefollowingrequirementsaremet,theconclusiononthetechnicalevaluationonsuggestionsonthenewfunctionshallbeurecommendingincludingitinthecatalogueofhealthfunctions”：(1) Theprojectofproposedmaterialsiscomplete;(2) Therearenosocial-ethicalconcerns;（二）不会引

29、起社会伦理学方面的担忧；(3)Thenameandexplanationofthehealthfunctionarescientificandreasonableandcanbecorrectlyunderstoodbyconsumers;（三）保健功能名称和解释科学合理、能够被消费者正确理解；(4)Thepurposeofthehealthfunctionisclear,notforthepurposeofdiseaseprevention,treatment,anddiagnosis;（四）保健功能目的明确，不以疾病的预防、治疗、诊断为目的；(5)Thepeoplesdemandforhe

30、althfunctionsareclear,andtheanalysisandsummaryofhealthfunctionsandthebodyshealtheffectsareinlinewithscientificconsensus;（五）保健功能人群健康需求明确，保健功能与机体健康效应的分析以及综述符合科学共识；(6)Thedataoncomparisonwithdomesticandforeignevaluationmethodsforhealthfunctionsandthetestreportonhealthfunctionevaluationcansupporttheappli

31、cability,stability,andoperabilityoftheevaluationmethodsandcriteriaforhealthfunctions;（六）与国内外功能评价方法的对比资料和保健功能评价试验报告，能够支持保健功能评价方法和判定标准适用性、稳定性、可操作性；(7)Theexperimentaldataandliteraturebasisfullysupportthatthestudysamplesmeetthesafety,healthfunctions,andqualitycontrollabilityrequirementsofthedietarysuppl

32、ementregistrationapplication;（七）试验数据和文献依据充分支持研究样品符合保健食品注册申请的安全性、保健功能和质量可控性要求；(8)ThehealthfunctionsguidedbytraditionalhealthcaretheoriescomplywithtraditionalChinesemedicinehealthcaretheories;and（）以传统养生保健理论为指导的保健功能，符合传统中医养生保健理论；(9)Theconclusionontheon-siteverification（九）现场核查结论符合要求。meetstherequirements

33、.第十七条对于技术评价结论 为“建议纳入保健功能目录”，食 品审评中心将新功能建议和技术评 价结论报送国家市场监督管理总 局。符合要求的，按照程序将新功 能纳入保健功能目录。Article 17 Forthetechnicalevaluationconclusionofrecommendingincludingitinthecatalogueofhealthfunctionsn,theCenterforFoodEvaluationshallsubmittotheStateAdministrationforMarketRegulationthesuggestionsonnewfunctionsa

34、ndthetechnicalevaluationconclusions.Iftherequirementsaremet,thenewfunctionsshallbeincludedinthecatalogueofhealthfunctionsaccordingtotheprocedures.对应的新功能保健食品关联审评结 论为“建议予以注册”的，食品审 评中心根据科学依据的充足程度， 明确新功能保健食品的保健功能声 称限定用语，分级标注保健功能声 称为“科学证据（非结论性证 据）/支持性研究证据（非结论性 证据）/有限的研究证据（非结论 性证据）表明产品具有*功能”， 报送国家市场监督管理总局

35、进行产 品注册。Iftherelevantevaluationconclusiononthecorrespondingdietarysupplementswithnewfunctionsis,recommendedtobegrantedregistration1,theCenterforFoodEvaluationshall,accordingtotheadequacyofscientificbasis,definetheprecisetermsstatedbythehealthfunctionsofdietarysupplementswithnewfunctions,indicatethat

36、scientificevidence(inconclusiveevidence)/0supportingresearchevidence(inconclusiveevidence)/limitedresearchevidence(inconclusiveevidence)has*functionasstatedbythehealthfunctions,andsubmitthemtotheStateAdministrationforMarketRegulationforproductregistration.第十八条出现下列情况之一 的，技术评价结论为“不符合保健 功能目录纳入条件”：Artic

37、le 18 Underanyofthefollowingcircumstances,thetechnicalevaluationconclusionshallbeunotmeetingtheconditionsforinclusioninthecatalogueofhealthfunctions11:（一）建议材料内容矛盾、前后不 符，真实性难以保证或者内容不完 整，无法证实建议的科学合理性；(1)Thecontentsoftheproposedmaterialsarecontradictory,inconsistent,orincomplete,ortheirauthenticityisdi

38、fficulttoguarantee,whichcannotconfirmthescientificrationalityoftheproposedmaterials;(2)Itiseasytocauseconcernsinsocialethics;（二）容易引起社会伦理学方面的担忧；(3)Thenameandexplanationofhealthfunctionsareunscientificandunreasonable,andthereisthepossibilityoffalsepublicity,withvulgarityorfeudalsuperstition;（三）保健功能名称和

39、解释不科学、不合理、存在虚假宣传的可能，带有庸俗或封建迷信色彩；(4)Thepurposeofhealthfunctionsisnotclear,orthepurposeistoprevent,treat,anddiagnosediseases;（四）保健功能目的不明确，以疾病的预防、治疗、诊断为目的；(5)Thepeoplesdemandforhealthfunctionsareunclear,andtheanalysisandsummaryofhealthfunctionsandthebodyshealtheffectsdonotconformtoscientificconsensus;（

40、五）保健功能人群健康需求不明确，保健功能与机体健康效应的分析以及综述不符合科学共识；(6)Theevaluationmethodsandcriteriaforhealthfunctionsarenotapplicable,stable,oroperable;（六）保健功能评价方法和判定标准不适用、不稳定、不可操作；(7)Thesafety,healthfunction,andqualitycontrollabilityoftheresearchsamplescannotfullysupporttheapplicabilityofthehealthfunctionevaluationtest;（

41、七）研究样品的安全性、保健功能和质量可控性不能充分支持保健功能评价试验适用性；(8)Thecomprehensiveevaluationconclusionondietarysupplementswithnewfunctionsis“recommendingdenyingregistration;（八）新功能保健食品综合审评结论为“建议不予注册”；(9)Theon-siteverificationconclusiondoesnotmeettherequirements;or（九）现场核查结论不符合要求;（十）其他不符合纳入保健食品功 能目录条件的情形。(10)Othercircumstance

42、sthatdonotmeettherequirementsforinclusioninthelistoffunctionsofdietarysupplements.第十九条新功能建议的技术 评价结论为“不符合保健功能目录 纳入条件”的，食品审评中心终止 新功能保健食品技术审评，将新功 能建议和新功能保健食品审评结论 报送国家市场监督管理总局。经核 准，食品审评中心应当告知建议人 技术评价意见和结论，并将新功能 建议资料退还建议人。Article19Iftheconclusiononthetechnicalevaluationofsuggestionsonanewfunctionis“notme

43、etingtheconditionsforinclusioninthecatalogueofhealthfunctions,jtheCenterforFoodEvaluationshallterminatethetechnicalevaluationofthedietarysupplementwiththenewfunction,andsubmittotheStateAdministrationforMarketRegulationthesuggestionsonthenewfunctionandtheevaluationconclusiononthedietarysupplementwith

44、thenewfunction.Uponapproval,theCenterforFoodEvaluationshallinformtheproposerofthetechnicalevaluationopinionsandconclusions,andreturnthematerialsproposedfornewfunctionstotheproposer.第五章上市后评价ChapterVPost-MarketingEvaluation第二十条 新功能保健食品批 准上市的，注册人应当按照以下要 求开展新功能保健食品上市后评 价：Article20Ifadietarysupplementwit

45、hnewfunctionsisapprovedformarketing,theregistrantshallcarryoutthepost-marketingevaluationofthedietarysupplementwithnewfunctionsaccordingtothefollowingrequirements:（一）制定新功能保健食品上市后 评价方案，采集产品销售、人群消 费、健康评价和投诉反馈等数据， 开展消费人群及健康效应的综合分 析，形成上市后评价年度自查报 告。(1) Formulatingapost-marketingevaluationplanfordietarysu

46、pplementswithnewfunctions,collectingdataonproductsales,crowdconsumption,healthevaluation,andcomplaintreporting,carryingoutacomprehensiveanalysisofconsumergroupsandhealtheffects,andforminganannualself-inspectionreportforpost-marketingevaluation.（二）选取符合要求的食品检验机 构或临床试验机构开展新功能评价 方法评价，除按照延续注册要求提 交资料外，在注册

47、证书有效期届满 6个月前，向食品审评中心提供不 少于2家符合要求的食品检验机构 或临床试验机构出具的新功能评价 方法验证报告。(2) Selectingfoodinspectioninstitutionsorclinicaltrialinstitutionsthatmeettherequirementstocarryouttheevaluationofnewfunctionevaluationmethods.Inadditiontosubmittingmaterialsaccordingtotherequirementsforrenewalofregistration,sixmonthsbeforetheexpirationofthevalidityperiodoftheregistrationcertificate,theCenterforFoodEvaluationisprovidedwiththeverificationreportsonnewfunctionevaluationmethodsissuedbynolessthantwofoodinspectioninstitutionsorclinicaltrialinstitutionsthatmeettherequirements.（三）根据自查报