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1、DocumentNumber:OrderNo.721oftheStateCouncilofthePeoplesRepublicofChinaAreaofLaw:FoodHygiene1.evelofAuthority:AdministrativeRegulationsIssuingAuthority:StateCouncilDateIssued:10-11-2019EffectiveDale12-01-2019Status:EffectiveRevisedby:DecisionoftheStandingCommitteeoftheNationalPeoplesCongresstoAmendEi
2、ghtLawsIncludingtheRoadTrafficSafetyLawofthePeoplesRepublicofChina(includingtheFireProtectionLaw,theLawonImportandExportCommodityInspection,theAdvertisingLaw,theGrasslandLaw,theCivilAviationLaw.theCustomsLawandtheFoodSafelyLaw)(Issuedon04-29-2021Effectiveon04-29-2021);DecisionoftheStandingCommitteeo
3、ftheNationalPeoplesCongresstoAmendEightIzWSincludingtheRoadTrafficSafetyLawofthePeoplesRepublicofChina(includingtheFireProtectionLaw,theLawonImportandExportCommodityInspection,theAdvertisingLaw.theGrasslandLaw,theCivilAviationLaw,theCustomsLawandtheFoodSafetyLaw)(Issuedon04-29-2021Effectiveon04-29-2
4、021);2016-2019ComparisonVersion2009-2016AnnotationVersionOrderoftheStateCouncilofthePeoplesRepublicofChina(No.721)TheRegulationontheImplementationoftheFoodSafetyLawofthePeoplesRepublicofChina,asrevisedandadoptedalthe42ndexecutivemeetingoftheStateCouncilonMarch26,2019,isherebyissued,andshallcomeintof
5、orceonDecemberL2019.Premier:LiKeqiangOctober11,2019RegulationontheImplementationoftheFoodSafetyLawof中华人民共和国国务院令(第721号)中华人民共和国食品安全法实施条例已经2019年3月26日国务院第42次常务会议修订通过,现将修订后的中华人民共和国食品安。条例公布,白2019年12月1日起施行。总理李克强2019年10月11日中华人民共和国食品安全法实施条例(IssuedbyOrderNo.557oftheStateCouncilofthePeoplesRepublicofChinaonJul
6、y20,2009,revisedinaccordancewiththeDecisionoftheStateCounciltoAmendCertainAdministrativeRegulationsonFebnJary6,2016,andrevisedandadoptedatthe42ndexecutivemeetingoftheStateCouncilonMarch26,2019)ChapterIGeneralProvisionsArticle 1 ThisRegulationisdevelopedinaccordancewiththeFoodSafetyLawofthePeoplesRep
7、ublicofChina(hereinafterreferredtoasthe“FoodSafetyLaw).Article 2 Foodproducersandtradersshallconductproductionandtradingactivitiesinaccordancewithlaws,regulationsandfoodsafetystandards,establishandimprovefoodsafetymanagementrules,andtakeeffectivemeasurestopreventandcontrolfoodsafetyrisks,soastoensur
8、efoodsafety.Article 3 TheFoodSafetyCommissionoftheStateCouncilshallberesponsibleforanalyzingfoodsafetysituation,conductingresearchandmakingoverallplanningtodirectfoodsafetywork,puttingforwardsignificantpoliciesandmeasuresforfoodsafetysupervisionandadministration,andurgingtheimplementationoffoodsafet
9、ysupervisionandadministrationresponsibilities.Thefoodsafetycommitteeofalocalpeoplesgovernmentatorabovethecountylevelshallconductwork(2009年7月20日中华人民共和国国务院令第557号公布根据2016年2月6日国务院关于修改部分行政法规的决定修订2019年3月26日国务院第42次常务会议修订通过)第一章总则第一条根据中华人民共和国食品安全法(以下简称食品安全法),制定本条例。第二条食品生产经营者应当依照法律、法规和食品安全标准从事生产经营活动,建立健全食品安全管
10、理制度,采取有效措施预防和控制食品安全风险,保证食品安全。第三条国务院食品安全委员会负责分析食品安全形势,研究部署、统筹指导食品安全工作,提出食品安全监督管理的重大政策措施,督促落实食品安全监督管理责任。县级以上地方人民政府食品安全委员会按照本级人民政府规定的职责开展工作。accordingtothedutiesprescribedbythepeoplesgovernmentatthesamelevel.Article 4 People,sgovernmentsatorabovethecountylevelshallestablishaunifiedandauthoritativefoodsa
11、fetysupervisionandadministrationsystem,andstrengthentheconstructionoffoodsafetysupervisionandadministrationcapability.Thefoodsafetysupervisionandadministrationdepartmentandotherrelevantdepartmentsofapeoplesgovernmentatorabovethecountylevelshallperformtheirdutiesinaccordancewiththelaw,strengthencoord
12、inationandcooperation,andconductfoodsafetysupervisionandadministrationinaneffectivemanner.Peoplesgovernmentsoftownshipsandtownsandsub-districtofficesshallsupportandassistfoodsafetysupervisionandadministrationdepartmentsofpeoplesgovernmentsatthecountylevelandtheirlocalofficesinfoodsafetysupervisionan
13、dadministrationinaccordancewiththelaw.Article 5 Thestateshallincludefoodsafetyknowledgeinthecontentofnationalqualityeducation,popularizescientificknowledgeandlegalknowledgeonfoodsafety,andenhancethefoodsafetyawarenessoftheentiresociety.ChapterIIMonitoringandAssessmentofFoodSafetyRisksArticle 6 Thehe
14、althadministrativedepartmentofapeople,s第四条县级以上人民政府建立统一权威的食品安全监督管理体制,加强食品安全监督管理能力建设。县级以上人民政府食品安全监督管理部门和其他有关部门应当依法履行职责,加强协调配合,做好食品安全监督管理工作。乡镇人民政府和街道办事处应当支持、协助县级人民政府食品安全监督管理部门及其派出机构依法开展食品安全监督管理工作。第五条国家将食品安全知识纳入国民素质教育内容,普及食品安全科学常识和法律知识,提高全社会的食品安全意识。第二章食品安全风险监测和评估第六条县级以上人民政府卫生行政部门会同同级食品安全监督管理等部门建立食品安全风险监
15、测会商机 制,汇总、分析风险监测数据,研判食品安全风险,形成 食品安全风险监测分析报告,报本级人民政府;县级以上 地方人民政府卫生行政部门还应当将食品安全风险监测分 析报告同时报上一级人民政府卫生行政部门。食品安全风 险监测会商的具体办法由国务院卫生行政部门会同国务院 食品安全监督管理等部门制定。第七条食品安全风险监测结果表明存在食品安全隐患,食品安全监督管理等部门经进一步调查确认有必要 通知相关食品生产经营者的,应当及时通知。接到通知的食品生产经营者应当立即进行自查,发现食品 不符合食品安全标准或者有证据证明可能危害人体健康 的,应当依照食品安全法第六卜三条的规定停止生产、经 营,实施食品召
16、回,并报告相关情况。governmentatorabovethecountylevelshall,inconjunctionwiththefoodsafetysupervisionandadministrationdepartmentandotherdepartmentsatthesamelevel,establishafoodsafetyriskmonitoringandconsultationmechanism,summarizeandanalyzeriskmonitoringdata,conductresearchonandjudgefoodsafetyrisks,formafoodsa
17、fetyriskmonitoringanalysisreport,andsubmitthereporttothepeoplesgovernmentatthesamelevel.Thehealthadministrativedepartmentofalocalpeoplesgovernmentatorabovethecountylevelshallalsosubmitthefoodsafetyriskmonitoringanalysisreporttothehealthadministrativedepartmentofthepeoplesgovernmentalthenexthigherlev
18、el.ThespecificmeasuresforfoodsafetyriskmonitoringandconsultationshallbedevelopedbythehealthadministrativedepartmentoftheStaleCouncilinconjunctionwiththefoodsafetysupervisionandadministrationdepartmentandotherdepartmentsoftheStateCouncil.Article 7 Wherethefoodsafetyriskmonitoringresultindicatestheexi
19、stenceofanypotentialfoodsafetyhazard,thefoodsafetysupen,isionandadministrationdepartmentandotherdepartmentsshall,inatimelymanner,notifytherelevantfoodproducerortraderiftheydeemitnecessaryuponconfirmationthroughfurtherinvestigation.Thefoodproducerortradershall,afterreceivingthenotice,immediatelycondu
20、ctself-inspection,ifitfindsthat(bodfailstocomplywithfoodsafetystandardsorthereisanyevidenceshowingthatsuchfoodmaydamagehumanhealth,thefoodproducerortradershallceaseproductionortrading,recallfoodandreporttherelevantinformationinaccordancewiththeprovisionofArticle63oftheFoodSafetyLaw.Article8Wheretheh
21、ealthadministrativedepartment,foodsafetysupervisionandadministrationdepartmentoranyotherdepartmentoftheStateCouncilfindsitnecessarytoconductsafetyassessmentofpesticides,fertilizers,veterinarydrugs,feedsandfeedadditives,amongothers,itshallofferasafetyassessmentproposaltotheagricultureadministrativede
22、partmentoftheStateCouncil.TheagricultureadministrativedepartmentoftheStateCouncilshallorganizeassessmentinatimelymanner,andnotifytherelevantdepartmentoftheStateCounciloftheassessmentresult.Article9ThefoodsafetysupervisionandadministrationdepartmentandotherrelevantdepartmentsoftheStateCouncilshallest
23、ablishafoodsafetyriskinformationexchangemechanism,andspecifythecontent,proceduresandrequirementsfortheexchangeoffoodsafetyriskinformation.ChapterIIIFoodSafetyStandardsArticle10ThehealthadministrativedepartmentoftheStateCouncilshall,inconjunctionwiththefoodsafetysupervisionandadministrationdepartment
24、,agricultureadministrativedepartmentandotherdepartmentsoftheStateCouncil,maketheplanningonnationalfoodsafetystandardsanditsannualimplementationplan.ThehealthadministrativedepartmentoftheStateCouncilshallpublishthedraftsoftheplanningonnationalfoodsafetystandardsanditsannualimplementationplanonitswebs
25、iteandsolicitpublicopinions.第;条国务院卫生行政、食品安全监督管理等部门发现需要对农药、肥料、兽药、饲料和饲料添加剂等进行安全性评估的,应当向国务院农业行政部门提出安全性评估建议。国务院农业行政部门应当及时组织评估,并向国务院有关部门通报评估结果。第九条国务院食品安全监督管理部门和其他有关部门建立食品安全风险信息交流机制,明确食品安全风险信息交流的内容、程序和要求。第三章食品安全标准第十条国务院卫生行政部门会同国务院食品安全监督管理、农业行政等部门制定食品安全国家标准规划及其年度实施计划。国务院卫生行政部门应当在其网站上公布食品安全国家标准规划及其年度实施计划的草案
26、,公开征求意见。第H-一条省、自治区、直辖市人民政府卫生行政 部门依照食品安全法第二十九条的规定制定食品安全地方 标准,应当公开征求意见。省、自治区、直辖市人民政府 卫生行政部门应当自食品安全地方标准公布之日起30个工 作日内,将地方标准报国务院卫生行政部门备案。国务院 卫生行政部门发现备案的食品安全地方标准违反法律、法 规或者食品安全国家标准的,应当及时予以纠正。食品安全地方标准依法废止的,省、自治区、直辖市人民政府卫生行政部门应当及时在其网站上公布废止情况。第十二条保健食品、特殊医学用途配方食品、婴 幼儿配方食品等特殊食品不属于地方特色食品,不得对其 制定食品安全地方标准。第十三条食品安全
27、标准公布后,食品生产经营者 可以在食品安全标准规定的实施FI期之前实施并公开提前Article11Thehealthadministrativedepartmentofthepeoplesgovernmentofaprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshallsolicitpublicopinionsondevelopinglocalfoodsafetystandardsinaccordancewiththeprovisionofArticle29oftheFoodSafetyLaw.T
28、hehealthadministrativedepartmentofthepeoplesgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshallsubmitlocalfoodsafetystandardstothehealthadministrativedepartmentoftheStateCouncilforrecordationwithin30workingdaysfromthedatewhensuchstandardsarepublished.Ifthehea
29、lthadministrativedepartmentoftheStateCouncilfindsthatanyrecordedlocalfoodsafetystandardsviolateanylaw,regulationornationalfoodsafetystandards,itshallordercorrectioninatimelymanner.Wherelocalfoodsafetystandardsarerepealedinaccordancewiththelaw,thehealthadministrativedepartmentofthepeoplesgovernmentof
30、theprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshall,inatimelymanner,announcetherepealthereofonitswebsite.Article 12 Healthfood,formulafoodforspecialmedicaluse,infantformulafoodandotherspecialfoodarenotlocalspecialtyfood,andnolocalfoodsafetystandardsshallbedevelopedforthe
31、m.Article 13 Afterfoodsafetystandardsarepublished,foodproducersandtradersmayimplementthefoodsafetystandardspriortothedateofentryintoforceofthestandardsandmake实施情况。publictheadvanceimplementationthereof.Article 14 Afoodproductionenterpriseshallnotdevelopenterprisestandardslowerthantherequirementsofthe
32、nationalorlocalfoodsafetystandards.Ifafoodproductionenterprisedevelopsenterprisestandardsinwhichthefoodsafetyindicatorsarestringentthanthoseinthenationalorlocalfoodsafetystandards,theenterpriseshallsubmittheenterprisestandardstothehealthadministrativedepartmentofthepeoplesgovernmentoftheprovince,aut
33、onomousregionormunicipalitydirectlyundertheCentralGovernmentforrecordation.Afoodproductionenterprisethatdevelopsenterprisestandardsshalldisclosethemforconsultationbythepublicfreeofcharge.ChapterIVFoodProductionandTradingArticle 15 Afoodproductionortradingpermitshallbevalidforfiveyears.Wheretheproduc
34、tionortradingconditionsofafoodproducerortraderchangeandnolongersatisfytherequirementsforfoodproductionortrading,thefoodproducerortradershallimmediatelytakecorrectivemeasures.Ifnecessary,thefoodproducerortradershallundergolicensingformalitiesonceagaininaccordancewiththelaw.第十四条食品生产企业不得制定低于食品安全国家标准或者地
35、方标准要求的企业标准。食品生产企业制定食品安全指标严于食品安全国家标准或者地方标准的企业标准的,应当报省、自治区、直辖市人民政府卫生行政部门备案。食品生产企业制定企业标准的,应当公开,供公众免费查阅。第四章食品生产经营第十五条食品生产经营许可的有效期为5年。食品生产经营者的生产经营条件发生变化,不再符合食品生产经营要求的,食品生产经营者应当立即采取整改措施:需要重新办理许可手续的,应当依法办理。Article 16 ThehealthadministrativedepartmentoftheState第十六条国务院卫生行政部门应当及时公布新的Councilshall,inatimelymann
36、er,announcethelistofnewfoodrawmaterialsandnewvarietiesoffoodadditivesandfood-relatedproductsandtheapplicablenationalfoodsafetystandards.ThehealthadministrativedepartmentoftheStateCouncilshall,inconjunctionwiththefoodsafetysupervisionandadministrationdepartmentoftheStateCouncil,updateinatimelymannert
37、helistofmaterialswhicharetraditionallyconsideredasfoodandtraditionalChinesemedicines.Article 17 Thefoodsafetysupervisionandadminisirat沁ndepartmentoftheStateCouncilshall,inconjunctionwiththeagricultureadministrativedepartmentandotherrelevantdepartmentsoftheSlateCouncil,specifythebasicrequirementsforf
38、ullprocesstracingoffoodsafety,anddirectfoodproducersandtraderstoestablishandimprovethefoodsafetytraceabilitysystemthroughinformationtechnologymeans.Thefoodsafetysupervisionandadministrationdepartmentandotherdepartmentsshalltaketheconstructionoftraceabilitysystemforinfantformulafoodandotherfoodtarget
39、edatspecificgroupsandotherfoodwithrelativelyhighfoodsafetyrisksorlargesalesvolumeasthefocusofsupervisionandinspection.Article 18 Foodproducersandtradersshallestablishafoodsafetytraceabilitysystem,andtruthfullyrecordandretainpurchaseinspection,ex-factoryinspection,foodsalesandotherinformationinaccord
40、ancewiththeprovisionsofthe食品原料、食品添加剂新品种和食品相关产品新品种目录以及所适用的食品安全国家标准。对按照传统既是食品又是中药材的物质目录,国务院卫生行政部门会同国务院食品安全监督管理部门应当及时更新。第十七条国务院食品安全监督管理部门会同国务院农业行政等有关部门明确食品安全全程追溯基本要求,指导食品生产经营者通过信息化手段建立、完善食品安全追溯体系。食品安全监督管理等部门应当将婴幼儿配方食品等针对特定人群的食品以及其他食品安全风险较高或者销售量大的食品的追溯体系建设作为监督检查的重点。第十八条食品生产经营者应当建立食品安全追溯体系,依照食品安全法的规定如实记录
41、并保存进货查验、出厂检验、食品销售等信息,保证食品可追溯。FoodSafetyLaw,soastoensurefoodtraceability.Article 19 Theprimarypersoninchargeofafoodproductionortradingenterpriseshallbefullyresponsibleforthefoodsafetyworkoftheenterprise,establishandimplementthefoodsafetyresponsibilitysystemoftheenterprise,strengthensuppliermanagement
42、,purchaseinspectionandex-factoryinspection,productionandtradingprocesscontrol,foodsafetyself-inspection,andotherwork.Foodsafetymanagersofthefoodproductionortradingenterpriseshallassisttheprimarypersoninchargeoftheenterpriseinmanagingfoodsafetyinaneffectivemanner.Article 20 Afoodproductionortradingen
43、terpriseshallstrengthenthetrainingandassessmentofitsfoodsafetymanagers.Foodsafetymanagersshallhaveacommandoffoodsafetylaws,regulations,standardsandprofessionalknowledgecommensuratewiththeirpositions,andshallhavefoodsafetymanagementcapabilities.Thefoodsafetysupervisionandadministrationdepartmentsshal
44、lconductrandomsupervision,inspectionandassessmentofenterprisesfoodsafetymanagers.TheassessmentguidelinesshallbedevelopedandissuedbythefoodsafetysupervisionandadministrationdepartmentoftheSlateCouncil.Article 21 Whereafoodorfoodadditiveproducerortraderentruststheproductionoffoodorfoodadditives,itshal
45、lentrusttheproductionwiththeproducerthathasobtainedthefoodproductionpermitorfoodadditiveproductionpermit,supervisetheproductionandberesponsibleforthesafetyof第十九条食品生产经营企业的主要负责人对本企业的食品安全工作全面负责,建立并落实本企业的食品安全责任制,加强供货者管理、进货查验和出厂检验、生产经营过程控制、食品安全自查等工作。食品生产经营企业的食品安全管理人员应当协助企业主要负责人做好食品安全管理工作。第二十条食品生产经营企业应当加强
46、对食品安全管理人员的培训和考核。食品安全管理人员应当掌握与其岗位相适应的食品安全法律、法规、标准和专业知识,具备食品安全管理能力。食品安全监督管理部门应当对企业食品安全管理人员进行随机监督抽查考核。考核指南由国务院食品安全监督管理部门制定、公布。第二*一条食品、食品添加剂生产经营者委托生产食品、食品添加剂的,应当委托取得食品生产许可、食品添加剂生产许可的生产者生产,并对其生产行为进行监督,对委托生产的食品、食品添加剂的安全负责。受托方应当依照法律、法规、食品安全标准以及合同约定进行生foodorfoodadditivesproduceduponentrustment.Theentrustedp
47、artyshallproducefoodinaccordancewithlaws,regulations,foodsafetystandardsandasagreeduponinthecontract,beresponsibleforproduction,andacceptthesupervisionoftheentrustingparty.Article 22 FoodproducersandtradersshallnotstoresubstanceslistedinthedirectorydevelopedinaccordancewiththeprovisionofArticle63oft
48、hisRegulationinfoodproductionandprocessingplaces.Article 23 Theirradiationprocessingoffoodshallcomplywithnationalfoodsafetystandards,andthefoodsubjecttoirradiationprocessingshallbeinspectedandmarkedinaccordancewiththerequirementsofnationalfoodsafetystandards.Article 24 Forthestorageandtransportoffoo
49、dthathasspecialrequirementsfortemperatureandhumidity,amongothers,healpresen,ation,refrigerationorfreezingequipmentandfacilitiesshallbeprovidedandtheireffectiveoperationsshallbemaintained.Article 25 Whereafoodproducerortraderentrustsfoodstorageandtransport,itshallexaminethecapabilityoftheentrustedpartytoguaranteefoo