【中英文对照版】电子烟产品技术审评实施细则（2024）.docx

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1、国家烟草专卖局关于修订印发电子烟产品技术审评实施细则的通知（国烟法（2024）120号）各省级烟草专卖局，中国烟草总公司郑州烟草研究院，上海新型烟草制品研究院有限公司，各有关单位：为进一步贯彻落实电子烟管理办法（国家烟草专卖局公告2022年第1号），规范电子烟产品技术审评工作，现将修订后的电子烟产品技术审评实施细则印发给你们，请认真遵照执行。国家烟草专卖局电子烟产品技术审评实施细则(2024)Detai1.edImp1.ementationRu1.esfortheTechnica1.ReviewofE-CigaretteProducts(2024)制定凯美：国京姻单令武马发文字号：UI烟点(2

2、024)120号公有Hi:2024.0B.13地行H朝：2024OB13效力位疥：部门视豆姓文外法也具别：爆草t农IssuingAuthorityStatcTobaccoMonopo1.yAdministrationDOCUmemNumberNo.1201224oftheStateTobaccoMonopo1.yAdminiMmtionDa1.eIswed:08-13-2024EtYccdvcDate.MDnUPoIyNoticebytheStateTobaccoMonopo1.yAdministrationofRevisingandIssuingtheDetai1.edImp1.ementa

3、tionRu1.esfortheTechnica1.ReviewofE-CigaretteProducts(No.1202024oftheStateTobaccoMonopo1.yAdministration)A1.1.provincia1.tobaccomonopo1.yadministrations,theZhengzhouTobaccoResearchInstituteofChinaNationa1.TobaccoCorporation,ShanghaiNewTobaccoProductResearchInstituteCo,1.td.,anda1.1.re1.evantentities

4、:Forthepurposesoffurtherimp1.ementingtheMeasuresfortheAdministrationofE-Cigarettes(AnnouncementNo.12022,StateTobaccoMonopo1.yAdministration)andregu1.atingthetechnica1.reviewofe-cigaretteproducts,therevisedDetai1.edImp1.ementationRu1.esfortheTechnica1.ReviewofE-CigaretteProductsareherebyissuedtoyoufo

5、ryourconscientiouscomp1.ianceandimp1.ementation.StateTobaccoMonopo1.yAdministrationAugust13,2024Detai1.edImp1.ementationRu1.esfortheTechnica1.ReviewofE-CigaretteProductsChapter I Genera1.ProvisionsArtic1.e1Forthepurposesofregu1.atingthemanagementoftechnica1.reviewofe-cigaretteproductsandprotectingth

6、erightsandinterestsofconsumers,theseDetai1.edRu1.esaredeve1.opedinaccordancewiththe1.awofthePeop1.esRepub1.icofChinaonTobaccoMonopo1.y,theRegu1.ationontheImp1.ementationofthe1.awofthePeop1.esRepub1.icofChinaonTobaccoMonopo1.y,theMeasuresfortheAdministrationofE-Cigarettes(AnnouncementNo.12022,StateTo

7、baccoMonopo1.yAdministration)andother1.awsandregu1.ations,ru1.es,andregu1.atorydocuments.Artic1.e2Thee-cigaretteproductstobeso1.dwithintheterritoryofthePeop1.esRepub1.icofChinasha1.1.passtechnica1.review.Thee-cigaretteproductsthatfai1.topasstechnica1.reviewsha1.1.notbep1.acedonthemarket.Artic1.e3For

8、thepurposeoftheseDetai1.edRu1.es,ue-cigaretteproductsinc1.udecartridges,cigarettedevices,disposab1.ee-cigarettes,ande-cigaretteproductsso1.dinapackagingunitaccordingtore1.evantnationa1.standards,amongothers.2024年8月13日电子烟产品技术审评实施细则第一章总则第一条为规范电子烟产品技术审评管理，保障消费者权益，根据中华人和国烟草专卖法中华人民共和国烟草专卖法实施条例及电子烟管理办法（国家

9、烟草专卖局公告2022年第1号）等法律法规、规章和规范性文件，制定本细则。第二条在中华人民共和国境内销售的电子烟产品，应当通过技术审评。未通过技术审评的电子烟产品，不得上市销售。第三条本细则所称电子烟产品包括烟弹、烟具、一次性电子烟以及按照国家有关标准在一个包装单元内销售的电子烟产品等。笫四条国务院烟草专卖行政主管部门负责技术审评管理制度的制定、发布、调整，以及技术审评实施的监督管理Artic1.e4Thetobaccomonopo1.yadministrativedepartmentoftheStateCounci1.sha1.1.beresponsib1.eforthedeve1.opme

10、nt,issuanceandadjustmentofthetechnica1.reviewmanagementsystemandthesupervisionandadministrationoftheimp1.ementationoftechnica1.review.Provincia1.tobaccomonopo1.yadministrativedepartmentssha1.1.beresponsib1.eforacceptingapp1.icationsforthetechnica1.reviewofe-cigaretteproductsandsupervisingandadminist

11、eringtheimp1.ementationoftechnica1.reviewwithintheirrespectiveregions.Thetobaccomonopo1.yadministrativedepartmentoftheStateCounci1.sha1.1.organizeprofessiona1.institutions(hereinafterreferredtoastechnica1.reviewinstitutions)toconductthetechnica1.reviewwork.Chapter II App1.icationArtic1.e5Theapp1.ica

12、ntsforthetechnica1.reviewofe-cigaretteproducts(hereinafterreferredtoasuapp1.icants)sha1.1.submittechnica1.reviewapp1.icationstotheprovincia1.tobaccomonopo1.yadministrativedepartmentsatthep1.acesofdomici1.esofenterprisesthroughtheManagementSystemfortheTechnica1.ReviewofE-CigaretteProducts(hereinafter

13、referredtoastheManagementSystem).Article 6 Anapp1.icantsha1.1.meetthefo1.1.owingconditions:(1) Ithastheenterprise1.ega1.personstatus.(2) Itisthetrademarkownerofthee-cigaretteproductsunderapp1.ication.工作。省级烟草专卖行政主管部门负责本行政区域内电子烟产品技术审评的申请受理，以及技术审评实施的监督管理工作。技术审评工作由国务院烟草专卖行政主管部门组织专业机构（以下称技术审评机构）实施。第二章申请第

14、五条电子烟产品技术审评申请人（以下简称申请人）应当通过电子烟产品技术审评管理系统（以下简称管理系统），向企业住所所在地省级烟草专卖行政主管部门提交技术审评申请。第六条申请人应当具备下列条件：（一）具有企业法人资格;（二）为所申请电子烟产品的商标权人；(3) Itmeetstherequirementsofthee-cigarette(三)符合国家电子烟产业政industrypo1.iciesofthestate.(4) Thespecificationsandquantitiesofexistingmarketab1.ee-cigaretteproductsmeetthere1.evantre

15、quirementsofthenationa1.unifiede-cigarettetradingmanagementp1.atform.(5) Otherconditionsasprescribedbythetobaccomonopo1.yadministrativedepartmentoftheStateCounci1.Ifthetrademarkownerisanoverseasenterprise,itsha1.1.authorizetheinstitutionformedbyitinsideChinaoritsagenttoapp1.ytothe1.oca1.provincia1.t

16、obaccomonopo1.yadministrativedepartment.Wheretheapp1.icationfi1.edbyanoverseasbrandho1.dingenterpriseishand1.ed,theapp1.icantsha1.1.meettheconditionsspecifiedinsubparagraphs(1),(3)and(5)oftheprecedingparagraph.Article 7 Anapp1.icantsha1.1.makeacommitmentonthe1.ega1.ity,authenticity,comp1.etenessandt

17、raceabi1.ityofthesubmittedmateria1.s.Article 8 Thee-cigaretteproductsundertheapp1.icationfortechnica1.reviewsha1.1.meetthefo1.1.owingconditions:(1) Theycomp1.ywiththecompu1.sorynationa1.standardE1.ectronicCigarette.策要求;（四）已有可销规格数量应符合全国统一电子烟交易管理平台的相关要求：（五）国务院烟草专卖行政主管部门规定的其他条件。商标权人为境外企业的，应当委托其在境内设立的机构

18、或代理商向属地省级烟草专卖行政主管部门申请。为境外品牌持有企业办理申请的，应当符合前款第一、三、五项的条件。笫七条申请人应当对所提交的材料的合法性、真实性、完整性、可溯源性作出承诺。笫八条申请技术审评的电子烟产品，应当具备下列条件：（一）符合电子烟强制性国家标准：（二）使用在中国核准注册的商标：(2) TheyusethetrademarksapprovedandregisteredinChina.(3) Theycomp1.ywiththere1.evantprovisionsonpackaging1.abe1.sandwarningsfore-cigaretteproducts.(4) O

19、therconditionsasprescribedbythetobaccomonopo1.yadministrativedepartmentoftheStateCounci1.Thecartridges,cigarettedevices,andthecombinationsthereofcontainedinthee-cigaretteproductsso1.dinapackagingunitsha1.1.bea1.1.productsthathavepassedtechnica1.review.（三）符合电子烟产品包装标识和警语的相关规定：（四）国务院烟草专卖行政主管部门规定的其他条件。在

20、一个包装单元内销售的电子烟产品，其内含烟弹与烟具及其匹配组合应均为已通过技术审评的产品。笫九条申请电子烟产品技术审评，应当提交下列资料：Artic1.e9Anapp1.icantforthetechnica1.reviewofe-Cigaretteproductssha1.1.submitthefo1.1.owingmateria1.s:(1)Basicinformationontheproducts.（一）产品的基础信息；(2)Trademarkregistrationcertificatesoftheproducts.（一）产品的商标注册证；(3)Productpackagingandap

21、pearancedesigndrawings.（三）产品包装及外观设计图：(4) Samp1.eproductspecifications.(5) Productdescriptionreports.(6) Productformu1.aandrawmateria1.sreports.（四）产品说明书样稿：（五）产品描述报告；（六）产品配方与原材料报告；(7) Descriptionsofkeyproductionprocesses(七)与安全性有关的关键生re1.atedtosafety.(8) Productinspectionandtestingreportsandothernecess

22、aryinspectionandtestingreports.(9) Productsafetyassessmentordemonstrationreports.(10) Theapp1.icants1.etterofcommitmentthatitisresponsib1.efortheauthenticityoftheapp1.icationmateria1.s.(11) Samp1.esofphysica1.productsunderapp1.ication.(12) Otherre1.evantmateria1.s.Asfore-cigaretteproductsso1.dinapac

23、kagingunit,on1.ythemateria1.sasprescribedinsubparagraphs(1)to(4)andsubparagraph(11)oftheprecedingparagraphneedtobesubmitted.Asforimportede-cigaretteproducts,thecertificationmateria1.sonobtainingapprova1.forproductionorsa1.einthecountries(regions)wheretheyare1.ocatedsha1.1.a1.sobeprovidedinadditionto

24、materia1.sspecifiedintheprecedingparagraph.产工艺说明;（八）产品检验检测报告及其他必要的检验检测报告；（九）产品安全性评估或论证报告；（十）申请人对申请材料真实性负责的承诺书；（-）申请实物样品;（十二）其他相关资料。在一个包装单元内销售的电子烟产品，仅需提交前款规定的（一）至（四）和（十一）项资料。进口电子烟产品除前款规定资料外，还需提供所在国家（地区）的获准生产或销售的证明材料。第十条省级烟草专卖行政主管部门应当自收到申请后8个工作日内组织完成对线上提交资料完整性、规范性的审查。符合条件的，出具纸质资料和实物样品邮寄通知书。Article 10

25、Aprovincia1.tobaccomonopo1.yadministrativedepartmentsha1.1.,withineightworkingdaysafterreceivinganapp1.ication,organizeandcomp1.etethereviewofthecomp1.etenessandstandardizationofthemateria1.ssubmittedon1.ine.Ifconditionsaremet,anoticeofmai1.ingofpapermateria1.sandsamp1.esofphysica1.productssha1.1.be

26、issued.Article 11 Afterreceivingamai1.ingnotice,anapp1.icantsha1.1.submitthepapertechnica1.reviewmateria1.sandsamp1.esofphysica1.productsconsistentwiththedescriptionsintheapp1.icationmateria1.stotheprovincia1.tobaccomonopo1.yadministrativedepartmentbymai1.第十一条申请人收到邮寄通知书后，应当以邮寄方式向省级烟草专卖行政主管部门提交与申请资料相

27、一致的技术审评纸质资料和实物样品。第三章技术审评ChapterIIITechnica1.ReviewArtic1.e12Technica1.reviewsha1.1.adheretotheprincip1.eofbeingscientific,fair,andefficient.笫十二条应当坚持科学、原则。技术审评工作公正、高效的笫十三条技术审评主要包括以下方面：（一）产品描述、配方与原材料报告的完整性、合理性：（二）相关检验检测报告的有效性、适用性：（三）产品安全性评估与论证的科学性、可靠性和充分性：（四）产品质量安全保障的合理性、可行性和可控性；（五）产品风味的符合性；Article 13

28、 Thecontentoftechnica1.reviewmain1.yinc1.udesthefo1.1.owingaspects:(1) Comp1.etenessandrationa1.ityofproductdescriptions,formu1.aandrawmateria1.reports.(2) Effectivenessandapp1.icabi1.ityofre1.evantinspectionandtestingreports.(3) Scientificity,re1.iabi1.ityandadequacyofproductsafetyassessmentanddemo

29、nstration.(4) Rationa1.ity,feasibi1.ityandcontro1.1.abi1.ityofproductqua1.ityandsafetyguarantee.(5) Conformityofproductf1.avor.(6) Otheritemsthatsha1.1.besubjecttotechnica1.(六)其他需进行技术审评的review.内容。笫十四条技术审评机构应当建立由相关专业领域专家构成的专家库。Article 14 Technica1.reviewinstitutionssha1.1.estab1.ishexpertpoo1.sconsis

30、tingofexpertsinre1.evantprofessiona1.fie1.ds.笫十五条技术审评机构负责对申请材料进行形式审查，合格后进行初审，提出审查意见，根据审评工作需要，从专家库中遴选人员组成审评专家组，以会议形式作出技术审评结论。Article 15 Technica1.reviewinstitutionssha1.1.beresponsib1.eforconductingforma1.examinationofapp1.icationmateria1.s,conductingpre1.iminaryexaminationoftheapp1.icationmateria1.s

31、thatpasstheforma1.examinationandputtingforwardexaminationopinions,and,accordingtotheneedsoftechnica1.review,se1.ectpersonne1.fromexpertpoo1.stoformreviewexpertgroupstodrawtechnica1.reviewconc1.usionsintheformofmeetings.第十六条技术审评机构应当在形式审查合格后60个工作日内完成技术审评。Article 16 Tp1.etethetechnica1.reviewwithin60wo

32、rkingdaysaftertheapp1.icationmateria1.shavepassedforma1.examination.笫十七条技术审评过程中，技术审评机构可根据实际需要开展相关复核检验、现场核查或要求申请人进一步补充有关证据材料。Article 17 Intheprocessoftechnica1.review,technica1.reviewinstitutionsmay,accordingtoactua1.needs,conductre1.evantreviewandinspectionoron-siteverificationorrequireapp1.icantsto

33、furthersupp1.ementre1.evantevidentiarymateria1.s.复核检验、现场核查、补充证据材料所需时间不计算在审评时限内。Thetimerequiredforreviewandinspection,on-siteverificationandsupp1.ementationofevidentiarymateria1.ssha1.1.notbeinc1.udedinthetime1.imitfortechnica1.review.第十八条国务院烟草专卖行政主管部门应当将通过技术审评的产品纳入交易管理平台，并实施动态管理。Article 18 Thetobacc

34、omonopo1.yadministrativedepartmentoftheStateCounci1.sha1.1.inc1.udeproductsthathavepassedtechnica1.reviewinthetransactionmanagementp1.atformfordynamicmanagement.第十九条企业注册信息发生变化，或因法定事由导致企业主体发生变化的，应当及时向原受理部门申请变更。Article 19 Wheretheregistrationinformationofanenterprisechanges,orabusinessentitychangesfor

35、any1.ega1.reason,anapp1.icationforchangesha1.1.befi1.edwiththeorigina1.acceptancedepartmentinatime1.ymanner.产品设计（包括外观、结构、配方、原材料等）发生变化,露重新申请技术审评。Ifproductdesign(inc1.udingappearance,structure,formu1.a,orrawmateria1.s,amongothers)changes,itisrequiredtore-app1.yfortechnica1.review.第二十条上市销售的电子烟产品与通过技术审评

36、的产品信息应当保持一致。Article 20 Theinformationone-cigaretteproductsmarketedsha1.1.beconsistentwiththatontheproductsthathavepassedtechnica1.review.第二十一条存在以下情形的，烟草专卖行政主管部门不予受理该申请人提交的技术审评申请：Article 21 Underanyofthefo1.1.owingcircumstances,atobaccomonopo1.yadministrativedepartmentsha1.1.notacceptthetechnica1.rev

37、iewapp1.icationsubmittedbyanapp1.icant:（一）被市场监督管理部门吊销营业执照的，或企业经营主体依法终止的；(1) Thebusiness1.icenseisrevokedbythemarketregu1.atorydepartment,orthebusinessentityisterminatedinaccordancewiththe1.aw.（二）被烟草专卖行政主管部门取消或暂停电子烟内销生产经营业务资格的：(2) Thequa1.ificationofproductionanddistributionofe-cigarettesfordomestics

38、a1.esiscance1.1.edorsuspendedbythetobaccomonopo1.yadministrativedepartment.（三）委托未获得烟草专卖生产企业许可证的企业进行生产的；(3) Theproductionisentrustedtoanenterprisethathasnotobtainedthetobaccomonopo1.yproductionenterprise1.icense.（四）申请时提交虚假资料的，或以不正当手段通过技术审评的；(4) Fa1.semateria1.saresubmittedwhentheapp1.icationisfi1.ed,

39、orthetechnica1.reviewispassedbyi1.1.icitmeans.（五）因涉嫌违法经营电子烟相关业务等已被烟草专卖行政主管部门或其他国家机关立案调查、尚未结案的；(5) Theapp1.icantisunderforma1.investigationbythetobaccomonopo1.yadministrativedepartmentoranyotherstateauthorityforbeingsuspectedofengaginginre1.evante-cigarettebusinessinvio1.ationof1.aws,andthecasehasnot

40、beenc1.osed.（六）违反法律、法规、规章规定的其他情形。(6) Othercircumstancesofvio1.ationsof1.aws,regu1.ationsandru1.es.第四章附则ChapterIVSupp1.ementa1.Provisions第二十二条电子烟相关生产企业应当建立完善的出口电子烟产品质量安全保证体系并确保运行有效。Artic1.e22E-cigarette-re1.atedmanufacturerssha1.1.estab1.ishsoundqua1.ityandsafetyassurancesystemsforexportede-cigarette

41、productsandensuretheeffectiveoperationthereof.第二十三条烟草专卖行政主管部门和技术审评机构的工作人员在技术审评及管理过程中存在玩忽职守、滥用职权、徇私舞弊等行为的，依法给予处分；涉嫉犯罪的，依法移交有关部门处理。Artic1.e23Whereatobaccomonopo1.yadministrativedepartmentoranystaffmemberofatechnica1.reviewinstitutionneg1.ectsitsorhisduties,abusesitsorhispower,orpracticesfavoritismorma

42、kesfa1.sificationforpersona1.gainsduringthetechnica1.reviewandmanagement,itorhesha1.1.begivendiscip1.inaryactioninaccordancewiththe1.aw:andwhoeverissuspectedofacrimesha1.1.betransferredtothere1.evantdepartmentforpunishmentinaccordancewiththe1.aw.第二十四条未经申请人同意，烟草专卖行政主管部门和技术审评机构的工作人员不得披露申请人提交的商业秘密、未披露信

43、息或者敏感商务信息，法律另有规定或者涉及国家安全、重大社会公共利益的除外。Artic1.e24Withouttheconsentofanapp1.icant,thestaffmembersofatobaccomonopo1.yadministrativedepartmentsha1.1.notdisc1.osethetradesecrets,undisc1.osedinformationorsensitivebusinessinformationsubmittedbytheapp1.icant,exceptasotherwiseprovidedforbyany1.aworexceptthatn

44、ationa1.securityormajorsocia1.andpub1.icinterestsareinvo1.ved.Article 25 TheseDetai1.edRu1.essha1.1.besubjectinterpretationbythetobaccomonopo1.yadministrativedepartmentoftheStateCounci1.笫二十五条本细则由国务院烟草专卖行政主管部门负责解释。第二十六条本细则自印发之日起施行。2022年4月15日印发的国家烟草专卖局印发关于促进电子烟产业法治化规范化的若干政策措施（试行）等四个文件的通知（国烟办（2022）43号）

45、文件中的电子烟产品技术审评实施细则同时废止。Article 26 TheseDetai1.edReintoforceonthedateofissuance,uponwhichtheDetai1.edImp1.ementationRu1.esfortheTechnica1.ReviewofE-CigaretteProductsintheNoticebytheStateTobaccoMonopo1.yAdministrationofIssuingFourDocumentsInc1.udingtheSevera1.Po1.iciesandMeasuresforPromotingthe1.ega1.izationandStandardizationoftheE-CigaretteIndustry(forTria1.Imp1.ementation)(No.4320221.Genera1.OfficeoftheStateTobaccoMonopo1.yAdministration)sha1.1.berepea1.ed.