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| Regulations on Pesticide Administration | | 农药管理条例 |
(Promulgated by Decree No. 216 of the State Council of the People's Republic of China on May 8, 1997, amended in accordance with the Decision of the State Council on Amending the Regulations on Pesticide Administration on November 29, 2001) | |
（１９９７年５月８日国务院令第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》修订） |
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| Chapter I General Provisions | | 第一章 总则 |
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| Article 1 These Regulations are formulated for the purposes of strengthening the supervision and administration of the production, marketing and use of pesticide, ensuring the quality of pesticide , protecting agricultural and forestry production and the ecological environment and safeguarding human and domestic animal health. | | 第一条 为了加强对农药生产、经营和使用的监督管理，保证农药质量，保护农业、林业生产和生态环境，维护人畜安全，制定本条例。 |
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| Article 2 The term "pesticide" as used in these Regulations refers to any substance or a mixture of substances chemically synthesized or originating from biological and other natural substances and the formulations made from these substances used for preventing, destroying or controlling diseases, pests, weeds and other harmful organisms inimical to agriculture and forestry and for regulating the growth of plants and insects. | | 第二条 本条例所称农药，是指用于预防、消灭或者控制危害农业、林业的病、虫、草和其他有害生物以及有目的地调节植物、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。 |
Pesticides mentioned in the preceding paragraph include the following used for different purposes and in different places: | |
前款农药包括用于不同目的、场所的下列各类： |
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| (1) to prevent, wipe out or control diseases, pests (including insects, ticks and mites), weeds, rodents, mollusks and other organisms harmful to agriculture and forestry; | | （一）预防、消灭或者控制危害农业、林业的病、虫（包括昆虫、蜱、螨）、草和鼠、软体动物等有害生物的； |
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| (2) to prevent, wipe out or control storage diseases, pests, rodents and other harmful organisms; | | （二）预防、消灭或者控制仓储病、虫、鼠和其他有害生物的； |
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| (3) to regulate the growth of plants and insects; | | （三）调节植物、昆虫生长的； |
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| (4) to preserve or fresh keep farm and forest products; | | （四）用于农业、林业产品防腐或者保鲜的； |
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| (5) to prevent, wipe out or control mosquitoes, flies, cockroaches, rodents and other harmful organisms; | | （五）预防、消灭或者控制蚊、蝇、蜚蠊、鼠和其他有害生物的； |
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| (6) to prevent, wipe out or control organisms harmful to dikes and dams, railroads, airports, buildings and other facilities. | | （六）预防、消灭或者控制危害河流堤坝、铁路、机场、建筑物和其他场所的有害生物的。 |
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| Article 3 The production, marketing and use of pesticides within the territory of the People's Republic of China shall comply with these Regulations. | | 第三条 在中华人民共和国境内生产、经营和使用农药的，应当遵守本条例。 |
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| Article 4 The State encourages and supports development, production and use of safe, highly effective and economical pesticides. | | 第四条 国家鼓励和支持研制、生产和使用安全、高效、经济的农药。 |
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| Article 5 The competent administrative department of agriculture of the State Council is responsible for the pesticide registration and pesticide supervision and administration throughout the country. The competent administrative departments of agriculture of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall assist the competent administrative department of agriculture of the State Council in conducting pesticide registration within their respective administrative areas, and are responsible for the pesticide supervision and administration within their respective administrative areas. The competent administrative departments of agriculture of the people's governments at the county level and the people's governments of cities divided into districts and autonomous prefectures are responsible for of pesticide supervision and administration within their respective administrative areas. | | 第五条 国务院农业行政主管部门负责全国的农药登记和农药监督管理工作。省、自治区、直辖市人民政府农业行政主管部门协助国务院农业行政主管部门做好本行政区域内的农药登记，并负责本行政区域内的农药监督管理工作。县级人民政府和设区的市、自治州人民政府的农业行政主管部门负责本行政区域内的农药监督管理工作。 |
Other relevant departments of the people's governments at or above the county level are responsible for the work related to pesticide supervision and administration within their respective functions and responsibilities. | |
县级以上各级人民政府其他有关部门在各自的职责范围内负责有关的农药监督管理工作。 |
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| Chapter II Registration of Pesticide | | 第二章 农药登记 |
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| Article 6 The State practices a pesticide registration system. | | 第六条 国家实行农药登记制度。 |
The production (including production of technical grade products, formulation and repackaging, and these references remain same hereinafter) and import of pesticide must be registered. | |
生产（包括原药生产、制剂加工和分装，下同）农药和进口农药，必须进行登记。 |
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| Article 7 The registration of the pesticides domestically produced and imported for the first time shall be conducted in light of the following three stages: | | 第七条 国内首次生产的农药和首次进口的农药的登记，按照下列三个阶段进行： |
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| (1) field test stage: When applying for registration of a pesticide, the developer of the pesticide shall submit an application for field test and the field test may only be carried out after the application is approved, pesticides at field test stage shall not be sold. | | （一）田间试验阶段：申请登记的农药，由其研制者提出田间试验申请，经批准，方可进行田间试验；田间试验阶段的农药不得销售。 |
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| (2) temporary registration stage: After the field test, for the pesticides that need to go through field test demonstration, or need to be placed on trial sale and those that need to be used under special circumstances, the manufacturer shall apply for temporary registration, and the field test demonstration and trial sale may only be carried out within the specified area after a Temporary Pesticide Registration Certificate is issued by the competent administrative department of agriculture of the State Council. | | （二）临时登记阶段：田间试验后，需要进行田间试验示范、试销的农药以及在特殊情况下需要使用的农药，由其生产者申请临时登记，经国务院农业行政主管部门发给农药临时登记证后，方可在规定的范围内进行田间试验示范、试销。 |
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| (3) formal registration stage: The manufacturer of pesticides that have been proved through field test demonstration and trial sale to be ready for commercial distribution shall apply for formal registration, and the production and distribution thereof may only be started after a Pesticide Registration Certificate is issued by the competent administrative department of agriculture of the State Council. | | （三）正式登记阶段：经田间试验示范、试销可以作为正式商品流通的农药，由其生产者申请正式登记，经国务院农业行政主管部门发给农药登记证后，方可生产、销售。 |
The pesticide Registration Certificate and Temporary Registration Certificate shall specify the term of validity of the registration. If it is necessary to continue producing or selling to China the pesticide products upon expiration of the term of validity of the registration, an application for renewal of registration shall be made before the expiration date. | |
农药登记证和农药临时登记证应当规定登记有效期限；登记有效期限届满，需要继续生产或者继续向中国出售农药产品的，应当在登记有效期限届满前申请续展登记。 |
For the pesticides that have been formally or temporarily registered, if the formulation, content or the scope and methods for use need to be changed within the term of validity of registration, an application for modification in the registration shall be made. | |
经正式登记和临时登记的农药，在登记有效期限内改变剂型、含量或者使用范围、使用方法的，应当申请变更登记。 |
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| Article 8 When applying for pesticide registration in accordance with the provisions of Article 7 of these Regulations, the developers, manufacturers or foreign enterprises selling pesticides to China shall submit pesticide samples to the competent administrative department of agriculture of the State Council directly or through the competent administrative departments of agriculture of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and shall, in accordance with the requirements for pesticide registration stipulated by the competent administrative department of agriculture of the State Council, present data on the chemical and toxicological properties, efficacy, residue, effects on the environment and labels of the pesticides. | | 第八条 依照本条例第七条的规定申请农药登记时，其研制者、生产者或者向中国出售农药的外国企业应当向国务院农业行政主管部门或者经由省、自治区、直辖市人民政府农业行政主管部门向国务院农业行政主管部门提供农药样品，并按照国务院农业行政主管部门规定的农药登记要求，提供农药的产品化学、毒理学、药效、残留、环境影响、标签等方面的资料。 |
The pesticide test agency subordinated to the competent administrative department of agriculture of the State Council is responsible for the concrete work of pesticide's registration throughout the country. Pesticide test agencies subordinated to the competent administrative departments of agriculture of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall give assistance in the concrete work of pesticide registration within their respective administrative areas. | |
国务院农业行政主管部门所属的农药检定机构负责全国的农药具体登记工作。省、自治区、直辖市人民政府农业行政主管部门所属的农药检定机构协助做好本行政区域内的农药具体登记工作。 |
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| Article 9 Pesticide administration specialists and pesticide technical specialists, recommended by the departments of agriculture, forestry, licensing administration of industrial products, public health, environmental protection, grains and other departments of the State Council and the All-China Federation of Supply and Marketing Cooperatives, constitute the review and adjudication board of pesticide registration. | | 第九条 国务院农业、林业、工业产品许可管理、卫生、环境保护、粮食部门和全国供销合作总社等部门推荐的农药管理专家和农药技术专家，组成农药登记评审委员会。 |
The data for formal pesticide registration shall, after being examined and signed with written comments respectively by the administrative departments of agriculture, licensing administration of industrial products, public health and environmental protection of the State Council and the All-China Federation of Supply and Marketing Cooperatives, be appraised by the review and adjudication board of pesticide registration regarding the chemical and toxicological properties, efficacy, residue and effects on the environment of the pesticides. Based on the appraisal of the review and adjudication board, those pesticides that are up to the qualifications shall be issued a Pesticide Registration Certificate by the competent administrative department of agriculture of the State Council. | |
农药正式登记的申请资料分别经国务院农业、工业产品许可管理、卫生、环境保护部门和全国供销合作总社审查并签署意见后，由农药登记评审委员会对农药的产品化学、毒理学、药效、残留、环境影响等作出评价。根据农药登记评审委员会的评价，符合条件的，由国务院农业行政主管部门发给农药登记证。 |
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| Article 10 The State offers protection to undisclosed test or other data acquired and submitted by the applicant of pesticide that has been granted initial registration and contains new chemical entities. | | 第十条 国家对获得首次登记的、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。 |
For a period of six years from the date of registration, if any second applicant applies for registration of pesticide by relying on the data provided in the preceding paragraph without the permission of the applicant who has been granted registration, the registration department shall grant no registration, unless the second applicant has submitted his own data. | |
自登记之日起６年内，对其他申请人未经已获得登记的申请人同意，使用前款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。 |
Except for the following circumstances, the registration department shall not disclose the data provided in the first paragraph: | |
除下列情况外，登记机关不得披露第一款规定的数据： |
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| (1) the disclosure of such data is necessary to protect the public; | | （一）公共利益需要； |
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| (2) steps have been taken to ensure that the data are protected against unfair commercial use. | | （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。 |
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| Article 11 Where a manufacturer intends to manufacture the same pesticide products already registered by other factories, the manufacturer shall make an application for pesticide registration, and present pesticide samples and data as required in Article 8 of these Regulations. A Pesticide Registration Certificate shall be issued by the competent administrative department of agriculture of the State Council. | | 第十一条 生产其他厂家已经登记的相同农药产品的，其生产者应当申请办理农药登记，提供农药样品和本条例第八条规定的资料，由国务院农业行政主管部门发给农药登记证。 |
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| Chapter III Production of Pesticide | | 第三章 农药生产 |
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| Article 12 Pesticide production shall follow the State industrial policies for the pesticide industry. | | 第十二条 农药生产应当符合国家农药工业的产业政策。 |
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| Article 13 The establishment of pesticide producing enterprises (including jointly operated enterprises, branch factories and pesticide workshops within non-pesticide producing enterprises) shall meet the following requirements, and shall, after the examination and approval by the departments for licensing administration of industrial products of provinces, autonomous regions and municipalities directly under the Central Government, be reported for approval to the administrative department of chemical industry of the State Council. However, if there are different provisions in laws and administrative regulations regarding the qualifying requirements for establishing enterprises as well as examining or approving organs, those provisions shall prevail. | | 第十三条 开办农药生产企业（包括联营、设立分厂和非农药生产企业设立农药生产车间），应当具备下列条件，并经企业所在地的省、自治区、直辖市工业产品许可管理部门审核同意后，报国务院工业产品许可管理部门批准；但是，法律、行政法规对企业设立的条件和审核或者批准机关另有规定的，从其规定： |
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| (1) staffing with technicians and skilled workers qualified to produce the pesticides it intends to produce; | | （一）有与其生产的农药相适应的技术人员和技术工人； |
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| (2) possessing necessary buildings, production facilities and sanitary conditions suitable for producing pesticides it intends to produce; | | （二）有与其生产的农药相适应的厂房、生产设施和卫生环境； |
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| (3) possessing facilities that meet the State standards for labor safety and sanitation as well as relevant rules for labor safety and sanitation management; | | （三）有符合国家劳动安全、卫生标准的设施和相应的劳动安全、卫生管理制度； |
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| (4) having product quality standards and product quality guarantee system; | | （四）有产品质量标准和产品质量保证体系； |
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| (5) the pesticides produced are those that have been granted pesticide registration according to law; | | （五）所生产的农药是依法取得农药登记的农药； |
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| (6) having pollution prevention and control facilities and measures that meet the State requirements for environmental protection, and discharging pollutants within the standards for discharge of pollutants stipulated by the State and localities. | | （六）有符合国家环境保护要求的污染防治设施和措施，并且污染物排放不超过国家和地方规定的排放标准。 |
Only after being approved may the pesticide producing enterprises apply to the organ for industry and commerce administration for business licenses. | |
农药生产企业经批准后，方可依法向工商行政管理机关申请领取营业执照。 |
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| Article 14 The State practices a licensing system for pesticide production. | | 第十四条 国家实行农药生产许可制度。 |
When producing pesticides for which national standards or trade standards are available, an application for a Pesticide Production License shall be submitted to the department for licensing administration of industrial products of the State Council. | |
生产有国家标准或者行业标准的农药的，应当向国务院工业产品许可管理部门申请农药生产许可证。 |
The production of pesticides for which national or trade standards are not yet available but enterprise standards are available shall, upon the examination and approval by the departments for licensing administration of industrial products of provinces, autonomous regions and municipalities directly under the Central Government, be reported to the administrative department of chemical industry of the State Council for approval, and be issued with the approval document for pesticide production. | |
生产尚未制定国家标准、行业标准但已有企业标准的农药的，应当经省、自治区、直辖市工业产品许可管理部门审核同意后，报国务院工业产品许可管理部门批准，发给农药生产批准文件。 |
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Article 15 Pesticide producing enterprises shall carry out the production in accordance with the product quality standards and technological processes for pesticide production, and the production records must be complete and accurate.
．．．．．． | | 第十五条 农药生产企业应当按照农药产品质量标准、技术规程进行生产，生产记录必须完整、准确。
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