中英对照农药管理条例(2022修订).docx

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1、(1997年5月8日中华人民共和国国务院令第216号发布 根据2001年11月29日国务院关于修改农药管理条 例的决定第一次修订2017年2月8日国务院第164 次常务会议修订通过 根据2022年3月29日国务院关 了修改和废止部分行政法规的决定第二次修订)第一章总 则第一条为了加强农药管理,保证农药质量,保障 农产品质量安全和人畜安全,保护农业、林业生产和生态 环境,制定本条例。RegulationonPesticideAdministration(2022Revision)DocumentNumber:OrderNo.752oftheStateCouncilofthePeoplesRepu

2、blicofChinaAreaofLaw:Fertilizer,Pesticide,AgriculturalFilms,andDieselOil1.evelofAuthority:AdministrativeRegulationsIssuingAuthority:StateCouncilDateIssued:03-29-2022EffectiveDale:05-01-2022Status:Effective2017-2022AnnotationVersion2001-2017ComparisonVersion1997-2001AnnotationVersionRegulationonPesti

3、cideAdministration农药管理条例(IssuedbyOrderNo.216oftheSlateCouncilofthePeoplesRepublicofChinaonMay8,1997;revisedforthefirsttimeaccordingtotheDecisionoftheStateCouncilonAmendingtheRegulationonPesticideAdministrationonNovember29,2001,andrevisedandadoptedatthe164thexecutivemeetingoftheStateCouncilonFebruarj

4、,8,2017;andrevisedforthesecondtimeaccordingtotheDecisionoftheStateCounciltoAmendandRepealCertainAdministrativeRegulationsonMarch29,2022)ChapterIGeneralProvisionsArticle1ThisRegulationisdevelopedforthepurposesofstrengtheningtheadministrationofpesticides,ensuringthequalityofpesticides,guaranteeingtheq

5、ualitysafetyofagriculturalproductsaswellasthesafetyofpeopleandlivestock,andprotectingagricultureandforestryproductionandecologicalenvironment.Article2ForthepurposeofthisRegulation,tpesticidesmeansanysubstanceoramixtureofsubstanceschemicallysynthesizedororiginatingfrombiologicalandothernaturalsubstan

6、cesandtheirpreparationsusedforpreventingorcontrollingdiseases,pests,weeds,ratsandotherharmfulorganismsendangeringagricultureandforestryandforpurposefullyregulatingthegrowthofplantsandinsects.“Pesticides“asprescribedintheprecedingparagraphshallbeusedfordifferentpurposesandindifferentplacesasfollows:(

7、1)Preventingorcontrollingdiseases,pests(includinginsects,ticksandmiles),weeds,rats,mollusksandotherharmfulorganismsendangeringagricultureandforestry.(2) Preventingorcontrollingdiseases,pests,ratsandotherharmfulorganismsatstorageandprocessingplaces.(3) Regulatingthegrowthofplantsandinsects.(4) Preven

8、tingthecorrosionoforkeepingfreshagriculturalandforestproducts.(5) Preventingorcontrollingmosquitoes,flies,cockroaches,ratsandotherharmfulorganisms.(6) Preventingorcontrollingtheharmfulorganismsendangeringriverdams,railroads,docks,airports,buildings第二条本条例所称农药,是指用于预防、控制危害农业、林业的病、虫、草、鼠和其他有害生物以及有目的地调节植物

9、、昆虫生长的化学合成或者来源于生物、其他天然物质的一种物质或者几种物质的混合物及其制剂。前款规定的农药包括用于不同目的、场所的下列各类:(一)预防、控制危害农业、林业的病、虫(包括昆虫、婢、蛾)、草、鼠、软体动物和其他有害生物;(二)预防、控制仓储以及加工场所的病、虫、鼠和其他有害生物;(三)调节植物、昆虫生长;(四)农业、林业产品防腐或者保鲜;(五)预防、控制蚊、蝇、蛰獭、鼠和其他有害生物;(六)预防、控制危害河流堤坝、铁路、码头、机场、建筑物和其他场所的有害生物。andotherplaces.Article 3 Thecompetentagriculturaldepartmentofthe

10、StateCouncilshalltakechargeofthesupen,isionandadministrationofpesticidesnationwide.Thecompetentagriculturaldepartmentsofthelocalpeoplesgovernmentsatorabovethecountylevelshalllakechargeofthesupen,isionandadministrationofpesticideswithintheirrespectiveadministrativeregions.Otherrelevantdepartmentsofth

11、epeoplesgovernmentsatorabovethecountylevelshalltakechargeoftherelevantsupervisionandadministrationofpesticideswithinthescopeoftheirrespectivefunctions.Article 4 ThelocalpeoplesgovernmentsatorabovethecountylevelshallstrengthentheorganizationandleadershipoftheSUPerViSionandadministrationofpesticides,a

12、ndincludepesticidesupervisionandadministrationexpendituresinthebudgetsofgovernmentsatthesamelevel,soastoguaranteetheimplementationofthesupervisionandadministrationofpesticides.Article 5 Pesticideproductionenterprisesandpesticideoperatorsshallberesponsibleforthesafetyandeffectivenessofthepesticidesth

13、eyproduceanddistribute,andconsciouslyacceptthegovernmentsupervisionandsocialsupervision.Pesticideproductionenterprisesandpesticideoperatorsshall第三条国务院农业主管部门负责全国的农药监督管理工作。县级以上地方人民政府农业主管部门负责本行政区域的农药监督管理工作。县级以上人民政府其他有关部门在各自职责范围内负责有关的农药监督管理工作。第四条县级以上地方人民政府应当加强对农药监督管理工作的组织领导,将农药监督管理经费列入本级政府预算,保障农药监督管理工作的

14、开展。第五条农药生产企业、农药经营者应当对其生产、经营的农药的安全性、有效性负责,自觉接受政府监管和社会监督。农药生产企业、农药经营者应当加强行业自律,规范生strengthenSeIrregUIation,andregulateproductionandoperation.Article 6 Thestateshallencourageandsupportthedevelopment,productionanduseofsafe,highlyeffectiveandeconomicalpesticides,boostthespecializeduseofpesticides,andpromo

15、tetheupgradingofthepesticideindustry.Theentitiesandindividualsthathavemadeoutstandingcontributionsduringthedevelopment,promotion,andsupervisionandadministrationofpesticidesandotherworkshallbecommendedorrewardedinaccordancewiththerelevantprovisionsofthestate.ChapterIIPesticideRegistrationArticle7Thes

16、tateshallimplementthepesticideregistrationsystem.PesticideproductionenterprisesandenterprisesthatexportpesticidestoChinashallapplyforpesticideregistrationinaccordancewiththeprovisionsofthisRegulation,andnewpesticidedevelopersmayapplyforpesticideregistrationinaccordancewiththeprovisionsofthisRegulati

17、on.TheinstitutioninchargeofpesticidetestingsubordinatedtothecompetentagriculturaldepartmentoftheStateCouncilshalltakechargeofthespecificworkofpesticideregistration.Theinstitutionsinchargeofpesticidetestingsubordinatedtothecompetentagriculturaldepartmentsofthepeoplesgovernmentsofprovinces,autonomousr

18、egionsandmunicipalitiesdirectlyundertheCentralGovernmentshall产、经营行为。第六条国家鼓励和支持研制、生产、使用安全、高效、经济的农药,推进农药专业化使用,促进农药产业升级。对在农药研制、推广和监督管理等工作中作出突出贡献的单位和个人,按照国家有关规定予以表彰或者奖励。第二章农药登记第七条国家实行农药登记制度。农药生产企业、向中国出口农药的企业应当依照本条例的规定申请农药登记,新农药研制者可以依照本条例的规定申请农药登记。国务院农业主管部门所属的负责农药检定工作的机构负责农药登记具体工作。省、自治区、直辖市人民政府农业主管部门所属的负

19、责农药检定工作的机构协助做好本行政区域的农药登记具体工作。giveassistanceineffectivelyconductingthespecificworkofpesticideregistrationwithintheirrespectiveadministrativeregions.Article8ThecompetentagriculturaldepartmentoftheStateCouncilshallformthepesticideregistrationreviewcommitteewhichtakeschargeofpesticideregistrationreview.

20、Thepesticideregistrationreviewcommitteeshallconsistofthefollowing:(1) Theexpertsofpesticideproductchemical,efficacy,toxicology,residues,environment,qualitystandardsandtesting,amongothers,recommendedbythedepartmentsofagriculture,forestry,sanitation,environmentalprotection,grains,industrialadministrat

21、ion,andworksafetysupervisionandadministration,andotherrelevantdepartmentsoftheStateCouncil,All-ChinaFederationofSupplyandMarketingCooperativesandotherentities.(2) RelevantexpertsoftheNationalExpertCommitteeforFoodSafetyRiskAssessment.(3) Representativesofthedepartmentsofagriculture,forestry,sanitati

22、on,environmentalprotection,grains,industrialadministration,andworksafetysupervisionandadministrationandotherrelevantdepartmentsoftheStateCouncil,All-ChinaFederationofSupplyandMarketingCooperativesandother第;条国务院农业主管部门组织成立农药登记评审委员会,负责农药登记评审。农药登记评审委员会由下列人员组成:(一)国务院农业、林业、卫生、环境保护、粮食、工业行业管理、安全生产监督管理等有关部门和

23、供销合作总社等单位推荐的农药产品化学、药效、毒理、残留、环境、质量标准和检测等方面的专家;(二)国家食品安全风险评估专家委员会的有关专家;(三)国务院农业、林业、卫生、环境保护、粮食、工业行业管理、安全生产监督管理等有关部门和供销合作总社等单位的代表。entities.农药登记评审规则由国务院农业主管部门制定。第九条申请农药登记的,应当进行登记试验。ThereviewrulesonpesticideregistrationshallbedevelopedbythecompetentagriculturaldepartmentoftheStateCouncil.Article 9 Anappli

24、cantforpesticideregistrationshallconductregistrationtesting.农药的登记试验应当报所在地省、自治区、直辖市人民政府农业主管部门备案。Theregistrationtestingofpesticidesshallbereportedtothecompetentagriculturaldepartmentofthepeoplesgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentattheplacewheretheapp

25、licantislocatedforrecordation.第十条登记试验应当由国务院农业主管部门认定的登记试验单位按照国务院农业主管部门的规定进行。Article 10 RegistrationtestingshallbeconductedbytheregistrationtestingentitydeterminedbythecompetentagriculturaldepartmentoftheStateCouncilinaccordancewiththeprovisionsofthecompetentagriculturaldepartmentoftheStateCouncil.与已取

26、得中国农药登记的农药组成成分、使用范围和使用 方法相同的农药,免予残留、环境试验,但已取得中国农 药登记的农药依照本条例第卜五条的规定在登记资料保护 期内的,应当经农药登记证持有人授权同意。ThepesticidesidenticalwiththosethathaveobtainedtheChinapesticideregistrationcertificatesintermsofthecomposition,usescopeandusemethodsshallbeexemptfrombeingsubjecttoresidueandenvironmentaltesting;butifthepe

27、sticidesthathaveobtainedtheChinapesticideregistrationcertificatesareduringtheregistrationmaterialprotectionperiodasprescribedinArticle15ofthisRegulation,theauthorizationandconsentofthepesticideregistrationcertificateholdersshallbeobtained.登记试验单位应当对登记试验报告的真实性负责。Registrationtestingentitiesshallberespo

28、nsiblefortheauthenticityoftheregistrationtestreports.第一条登记试验结束后,申请人应当向所在地 省、自治区、直辖市人民政府农业主管部门提出农药登记 申请,并提交登记试验报告、标签样张和农药产品质量标 准及其检验方法等申请资料;申请新农药登记的,还应当 提供农药标准品。Article 11 Aftertheconclusionofregistrationtesting,anapplicantshallfileanapplicationforpesticideregistrationwiththecompetentagriculturaldepa

29、rtmentofthepeoplesgovernmentsoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentattheplacewhereitislocatedandsubmittheregistrationtestingreport,labelsampleandpesticideproductqualitystandardanditsinspectionmethodsandotherapplicationmaterials.Whereanapplicationfortheregistrat

30、ionofanewpesticideismade,thestandardsampleofthepesticideshallbeprovided.省、自治区、直辖市人民政府农业主管部门应当自受理申请之日起20个工作日内提出初审意见,并报送国务院农业 主管部门。Thecompetentagriculturaldepartmentofthepeoplesgovernmentsoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentshall,within20workingdaysasoftheaccep

31、tanceoftheapplication,putforwardthepreliminaryexaminationopinionsandsubmitthemtothecompetentagriculturaldepartmentoftheStateCouncil.向中国出口农药的企业申请农药登记的,应当持本条第一 款规定的资料、农药标准品以及在有关国家(地区)登 记、使用的证明材料,向国务院农业主管部门提出申请。第十二条 国务院农业主管部门受理申请或者收到 省、自治区、直辖市人民政府农业主管部门报送的申请资 料后,应当组织审查和登记评审,并自收到评审意见之日Whereanenterpriset

32、hatexportspesticidestoChinaappliesforpesticideregistration,itshall,uponthestrengthofthematerialsandthestandardsampleofthepesticideasprescribedinparagraph1ofthisArticle,andthecertificationmaterialsregisteredandusedintherelevantcountry(region),Ieanapplicationwiththecompetentagriculturaldepartmentofthe

33、StateCouncil.Article 12 ThecompetentagriculturaldepartmentoftheStaleCouncilshall,afteracceptinganapplicationorreceivingtheapplicationmaterialssubmittedbythecompetentagriculturaldepartmentofthepeoplesgovernmentoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernment,organizeexami

34、nationandregistrationreview,andmakeanapprovalordisapprovaldecisionwithin20workingdaysasofreceiptofthereviewopinions.Wheretheapplicationmeetstheconditions,thepesticideregistrationcertificateshallbeissued;orwheretheapplicantfailstomeettheconditions,theapplicantshallbenotifiedinwritingandthereasonsther

35、eforshallbegiven.Article13Apesticideregistrationcertificateshallspecifythepesticidename,dosageform,activeingredientsandtheircontents,toxicity,usescope,usemethodanddosage,registrationcertificateholder,registrationcertificatenumberandperiodofvalidityandothermatters.Apesticideregistrationcertificatesha

36、llbevalidforfiveyears.Where,aftertheexpirationoftheperiodofvalidity,itisnecessarytocontinuetheproductionofpesticidesorexportpesticidestoChina,thepesticideregistrationcertificateholdershall,90daysbeforetheexpirationoftheperiodofvalidity,applytothecompetentagriculturaldepartmentoftheStaleCouncilIbrthe

37、renewalthereof.Whereanymatterspecifiedonapesticideregistrationcertificatechanges,thepesticideregistrationcertificateholdershallapplyformodifyingthepesticideregistrationcertificateinaccordancewiththeprovisionsofthecompetentagriculturaldepartmentoftheStateCouncil.Thecompetentagriculturaldepartmentofth

38、eSlateCouncil起20个工作日内作出审批决定,符合条件的,核发农药登记证;不符合条件的,书面通知申请人并说明理由。第十三条农药登记证应当载明农药名称、剂型、有效成分及其含量、毒性、使用范围、使用方法和剂量、登记证持有人、登记证号以及有效期等事项。农药登记证有效期为5年。有效期届满,需要继续生产农药或者向中国出口农药的,农药登记证持有人应当在有效期届满90日前向国务院农业主管部门申请延续。农药登记证载明事项发生变化的,农药登记证持有人应当按照国务院农业主管部门的规定申请变更农药登记证。国务院农业主管部门应当及时公告农药登记证核发、延shallannounceinatimelymanne

39、rtheinformationonthe据:issuance,renewalandmodificationofthepesticideregistrationcertificateandthequalitystandardnumberoftherelevantpesticideproduct,residuelimitprovisions,inspectionmethods,approvedlabelandotherinformation.Article14Anewpesticidedevelopermaytransfertheregistrationmaterialsonthenewpesti

40、cidesforwhichithasobtainedtheregistrationcertificate;andthepesticideproductionenterprisemaytransfertoanotherpesticideproductionenterprisewiththecorrespondingproductioncapacitytheregistrationmaterialsonthepesticidesforwhichithasobtainedtheregistrationcertificate.Article15Thestateshallprotectthetestin

41、gdataandotherdatasubmittedbyanapplicantforthepesticideforwhichtheregistrationcertificatehasbeenobtainedforthefirsttimeorwhichcontainsnewcompounds,whichisobtainedbytheapplicantitselfandhasnotbeendisclosed.Where,withinsixyearsfromthedateofregistration,anotherapplicantappliesforpesticideregistrationwit

42、hthedataasprescribedintheprecedingparagraphwithouttheconsentoftheapplicantthathasobtainedtheregistrationcertificate,theregistrationauthorityshallnotgrantregistration,exceptthatsuchanotherapplicantsubmitsthedataobtainedbyitself.Exceptunderthefollowingcircumstances,aregistrationauthorityshallnotdisclo

43、sethedataasprescribedinparagraph1ofthisArticle:续、变更情况以及有关的农药产品质量标准号、残留限量规定、检验方法、经核准的标签等信息。第十四条新农药研制者可以转让其已取得登记的新农药的登记资料:农药生产企业可以向具有相应生产能力的农药生产企业转让其已取得登记的农药的登记资料。第十五条国家对取得首次登记的、含有新化合物的农药的申请人提交的其自己所取得且未披露的试验数据和其他数据实施保护。自登记之日起6年内,对其他申请人未经已取得登记的申请人同意,使用前款规定的数据申请农药登记的,登记机关不予登记;但是,其他申请人提交其自己所取得的数据的除外。除下列情

44、况外,登记机关不得披露本条第一款规定的数(1) Thedataisneededforthepublicinterests.(一)公共利益需要;(2) Measureshavebeentakentoguaranteethatsuchinformationwillnotbeunjustlyusedforcommercialpurposes.ChapterIIIPesticideProductionArticle16Pesticideproductionshallcomplywithnationalindustrialpolicies.Thestateshallencourageandsupport

45、theadoptionofadvancedtechnologiesandadvancedadministrationnormsbypesticideproductionenterprises,andimprovethesafetyandeffectivenessofpesticides.Article17Thestateshallimplementalicensingsystemforpesticideproduction.Apesticideproductionenterpriseshallmeetthefollowingconditions,and,inaccordancewiththep

46、rovisionsofthecompetentagriculturaldepartmentoftheStaleCouncil,applyforthepesticideproductionlicensetothecompetentagriculturaldepartmentofthepeoplesgovernmentsoftheprovince,autonomousregionormunicipalitydirectlyundertheCentralGovernmentinaccordancewiththeprovisionsofthecompetentagriculturaldepartmen

47、toftheSlateCouncil:(1) Havingthetechnicalpersonnelsuitableforthepesticidesitappliesforproduction.(2) Havingthefactorybuildingsandfacilitiesappropriateforthepesticidesitappliesforproduction.(二)已采取措施确保该类信息不会被不正当地进行商业使用。第三章农药生产第十六条农药生产应当符合国家产业政策。国家鼓励和支持农药生产企业采用先进技术和先进管理规范,提高农药的安全性、有效性。第十七条国家实行农药生产许可制度。

48、农药生产企业应当具备下列条件,并按照国务院农业主管部门的规定向省、自治区、直辖市人民政府农业主管部门申请农药生产许可证:(一)有与所申请生产农药相适应的技术人员;(二)有与所申请生产农药相适应的厂房、设施;(3) Havingthepersonnel,instrumentsandequipmentforthequalityadministrationandqualityinspectionofthepesticidesitappliesforproduction.(4) Havingtherulesandregulationsthatcanguaranteethequalityofthepesticidesitappliesforproduction.Thecompetentagriculturaldepartmentofthepeoplesgovernmentoftheprovince,autonomousregionormunicipalitydirect

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