| Order of the Ministry of Agriculture | | 农业部令 |
| (No. 3 [2017]) | | （2017年第3号） |
| The Measures for the Administration of the Pesticide Registration, as deliberated and adopted at the 6th executive meeting of the Ministry of Agriculture in 2017, are hereby issued and shall come into force on August 1, 2017. | | 《农药登记管理办法》已经农业部2017年第6次常务会议审议通过，现予公布，自2017年8月1日起施行。 |
| Minister: Han Changfu | | 部长 韩长赋 |
| June 21, 2017 | | 2017年6月21日 |
| Measures for the Administration of the Pesticide Registration | | 农药登记管理办法 |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of regulating the act of pesticide registration, strengthening the administration of pesticide registration, and protecting the safety and effectiveness of pesticide, these Measures are developed under the Regulation on Pesticide Administration. | | 第一条 为了规范农药登记行为，加强农药登记管理，保证农药的安全性、有效性，根据《农药管理条例》，制定本办法。 |
| Article 2 Pesticide produced, operated and used within the territory of the People's Republic of China shall obtain pesticide registration. | | 第二条 在中华人民共和国境内生产、经营、使用的农药，应当取得农药登记。 |
| Pesticide for which no pesticide registration certificate has been obtained according to the law shall be handled as fake pesticide. | | 未依法取得农药登记证的农药，按照假农药处理。 |
| Article 3 The Ministry of Agriculture (“MOA”) shall be responsible for the administration of pesticide registration across the country, organize the formation of the Pesticide Registration Review Committee, and develop the rules for the review of pesticide registration. | | 第三条 农业部负责全国农药登记管理工作，组织成立农药登记评审委员会，制定农药登记评审规则。 |
| The institution in charge of the verification of pesticide under the MOA shall be responsible for the specific work of pesticide registration across the country. | | 农业部所属的负责农药检定工作的机构负责全国农药登记具体工作。 |
| Article 4 The competent agricultural departments of the people's governments at the provincial level (hereinafter referred to as the “provincial agriculture departments”) shall be responsible for accepting the applications for pesticide registration within their respective administrative regions, review the application materials, and offer opinions of the preliminary review. | | 第四条 省级人民政府农业主管部门（以下简称省级农业部门）负责受理本行政区域内的农药登记申请，对申请资料进行审查，提出初审意见。 |
| The institutions in charge of the verification of pesticide under the provincial agriculture departments (hereinafter referred to as the “provincial pesticide verification institutions”) shall effectively assist in the specific work of pesticide registration. | | 省级农业部门负责农药检定工作的机构（以下简称省级农药检定机构）协助做好农药登记具体工作。 |
| Article 5 Pesticide registration shall be conducted under the principles of scientificity, fairness, impartiality, efficiency and facilitating people. | | 第五条 农药登记应当遵循科学、公平、公正、高效和便民的原则。 |
| Article 6 The registration of safe, efficient and economical pesticides shall be encouraged and supported, and the elimination of pesticides with high risk for agriculture, forestry, human and animal safety, agricultural product quality and safety, ecological environment, etc. shall be accelerated. | | 第六条 鼓励和支持登记安全、高效、经济的农药，加快淘汰对农业、林业、人畜安全、农产品质量安全和生态环境等风险高的农药。 |
| Chapter II Basic Requirements | | 第二章 基本要求 |
| Article 7 The Chinese common name or simplified Chinese common name shall be used as the name of pesticide, and the name of plant plus the extract may be used for the name of a botanical pesticide. The functional descriptive term plus dosage form shall be used for the name of a directly used sanitation pesticide. | | 第七条 农药名称应当使用农药的中文通用名称或者简化中文通用名称，植物源农药名称可以用植物名称加提取物表示。直接使用的卫生用农药的名称用功能描述词语加剂型表示。 |
| Article 8 The content and dosage form of active ingredients in pesticide shall be set under the principles of improving the quality, protecting the environment and promoting sustainable development of agriculture. | | 第八条 农药有效成分含量、剂型的设定应当符合提高质量、保护环境和促进农业可持续发展的原则。 |
| The formula of the preparation product shall be scientific, reasonable and convenient for use. The content gradient of a single preparation product with the same active ingredient and dosage form shall not exceed three. Mixed preparations shall have no more than two active ingredients, and shall have no more than three active ingredients such as herbicide, seed treatments and pheromone. Mixed preparations with the same active ingredient and dosage form shall have no more than three ratios, and the total content gradients of the same ratio shall not exceed three. Pesticides with low active ingredient content that are directly used without dilution or dispersion shall be separately classified. The specific requirements shall be developed separately by the MOA. | | 制剂产品的配方应当科学、合理、方便使用。相同有效成分和剂型的单制剂产品，含量梯度不超过三个。混配制剂的有效成分不超过两种，除草剂、种子处理剂、信息素等有效成分不超过三种。有效成分和剂型相同的混配制剂，配比不超过三个，相同配比的总含量梯度不超过三个。不经稀释或者分散直接使用的低有效成分含量农药单独分类。有关具体要求，由农业部另行制定。 |
| Article 9 The MOA shall publish and adjust the list of prohibited and restricted additives and the limits for quantity according to the toxicity and harmfulness of pesticide additives at appropriate time. | | 第九条 农业部根据农药助剂的毒性和危害性，适时公布和调整禁用、限用助剂名单及限量。 |
| Where designated additives need to be added in the use, corresponding experiment materials shall be submitted when an application for pesticide registration is filed. | | 使用时需要添加指定助剂的，申请农药登记时，应当提交相应的试验资料。 |
| Article 10 The dilution ratio or use concentration of a pesticide product shall match the application technique. | | 第十条 农药产品的稀释倍数或者使用浓度，应当与施药技术相匹配。 |
| Article 11 The relevant data or materials provided by an applicant shall be able to meet the needs of the risk assessment, and the product and the registered product shall have obvious advantages in safety and effectiveness. | | 第十一条 申请人提供的相关数据或者资料，应当能够满足风险评估的需要，产品与已登记产品在安全性、有效性等方面相当或者具有明显优势。 |
| The examination of a product for which an application is filed for registration shall be conducted under the principle of maximum risk when the risk assessment results of a registered product need to be consulted. | | 对申请登记产品进行审查，需要参考已登记产品风险评估结果时，遵循最大风险原则。 |
| Article 12 An applicant shall concurrently submit both paper documents and electronic documents and shall be responsible for the authenticity and legitimacy of the materials provided. | | 第十二条 申请人应当同时提交纸质文件和电子文档，并对所提供资料的真实性、合法性负责。 |
| Chapter III Application and Acceptance | | 第三章 申请与受理 |
| Article 13 An applicant shall be a pesticide manufacturer, an enterprise exporting pesticides to China, or a developer of new pesticides. | | 第十三条 申请人应当是农药生产企业、向中国出口农药的企业或者新农药研制者。 |
| A pesticide manufacturer means a domestic enterprise that has obtained a pesticide production license. An enterprise exporting pesticides to China (hereinafter referred to as the “overseas enterprise”) means an enterprise exporting pesticides manufactured overseas to China. A developer of new pesticides means a Chinese citizen, legal person or other organization that develops new pesticides within the territory of China. | | 农药生产企业，是指已经取得农药生产许可证的境内企业。向中国出口农药的企业（以下简称境外企业），是指将在境外生产的农药向中国出口的企业。新农药研制者，是指在我国境内研制开发新农药的中国公民、法人或者其他组织。 |
| For a new pesticide jointly developed by multiple entities, one of the entities shall be specified as the applicant, and other cooperative development institutions and the homogeneous supporting materials of a relevant experiment specimen shall be specified. Other entities shall not repeatedly file applications. | | 多个主体联合研制的新农药，应当明确其中一个主体作为申请人，并说明其他合作研制机构，以及相关试验样品同质性的证明材料。其他主体不得重复申请。 |
| Article 14 A domestic applicant shall file an application for pesticide registration with the provincial agricultural department in the place where it is located. An overseas enterprise shall file an application for pesticide registration with the MOA. | | 第十四条 境内申请人向所在地省级农业部门提出农药登记申请。境外企业向农业部提出农药登记申请。 |
| Article 15 An applicant shall submit the experiment report on the chemical and toxicological properties, efficacy, residue, environmental impact, etc. of a product, the risk assessment report, the label or specification sample, the product safety data sheet, the relevant document literature, the application form, the applicant's qualification proof, the declaration on the authenticity of the materials and other application materials. | | 第十五条 申请人应当提交产品化学、毒理学、药效、残留、环境影响等试验报告、风险评估报告、标签或者说明书样张、产品安全数据单、相关文献资料、申请表、申请人资质证明、资料真实性声明等申请资料。 |
| The pesticide registration application materials shall be authentic, standardized, complete and effective, and the specific requirements shall be developed separately by the MOA. | | 农药登记申请资料应当真实、规范、完整、有效，具体要求由农业部另行制定。 |
| Article 16 A registration experiment report shall be issued by a registration and experiment entity recognized by the MOA and may also be issued by a relevant overseas laboratory that has signed a mutual recognition agreement with the relevant department of the Chinese government; but the experiment of the efficacy, residue, environmental impact and other factors closely related to the environmental conditions, and the registration and experiment of the Chinese endemic species shall be completed within the territory of China. | | 第十六条 登记试验报告应当由农业部认定的登记试验单位出具，也可以由与中国政府有关部门签署互认协定的境外相关实验室出具；但药效、残留、环境影响等与环境条件密切相关的试验以及中国特有生物物种的登记试验应当在中国境内完成。 |
| Article 17 To apply for the registration of a new pesticide, an applicant shall concurrently submit the applications for the registration of the original drug of the new pesticide and the preparations of the new pesticide, and provide standard sample of pesticide. | | 第十七条 申请新农药登记的，应当同时提交新农药原药和新农药制剂登记申请，并提供农药标准品。 |
| Within six years from the date of the registration of a new pesticide, other applicant that submits the data obtained by itself or authorized and agreed by the holder of a certificate for the registration of a new pesticide to apply for the registration shall undergo the formalities as applying for the registration of a new pesticide. | | 自新农药登记之日起六年内，其他申请人提交其自己所取得的或者新农药登记证持有人授权同意的数据申请登记的，按照新农药登记申请。 |
| Article 18 The complete registration materials satisfying the requirements for the registration materials independently owned by a holder of a pesticide registration certificate may be used by other applicants upon authorization. | | 第十八条 农药登记证持有人独立拥有的符合登记资料要求的完整登记资料，可以授权其他申请人使用。 |
Where the pesticide registration materials are transferred under the provisions of Article 14 of the Regulation on Pesticide Administration, the transferee shall, upon strength of the contract on transfer and the registration materials satisfying the requirements for the registration materials, apply for pesticide registration.
．．．．．． | | 按照《农药管理条例》第十四条规定转让农药登记资料的，由受让方凭双方的转让合同及符合登记资料要求的登记资料申请农药登记。
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