中华人民共和国农业农村部公告269号【中英文双语专刊】

 2020-06-12

中华人民共和国农业农村部公告269号

Announcement No. 269 of the Ministry of Agriculture and Rural Affairs, China

为贯彻落实国务院“放管服”改革精神, 促进农药出口贸易，优化营商环境，根据《农药管理条例》《农药登记管理办法》，现就不在我国境内使用的出口农药（简称“仅限出口农药”）产品登记有关事项公告如下。

In order to implement the State Council's " Streamline administration, delegate powers, and improve regulation and services", promote pesticides export, and optimize the business environment, according to the” Regulations on the Management of Pesticides” and the “Measures on the Management of Pesticide Registration”, the relevant matters concerning the registration of exported pesticides which are not used in China (hereinafter referred to as " Export-only Pesticides ") are hereby announced as follows.

一、申请仅限出口农药登记的范围
1. Scope of registration application for export-only pesticides

在境外取得农药登记或取得进口国（地区）进口许可的产品，符合以下条件之一，农药生产企业可以申请仅限出口农药登记。

If one of the following conditions is met, a pesticide production enterprise may apply for export-only pesticide registration when a product has obtained a pesticide registration abroad or obtained an import permit from the importing country (region).

（一）本企业在境内已取得原药登记，申请相同有效成分不同含量的原药登记的。
（1）The enterprise has already obtained the registration of the TCs within the territory of  China，and applies for registration of different contents of the TCs with the same active ingredients.

（二）本企业在境内已取得原药或单制剂登记，申请相同有效成分不同含量、不同剂型单制剂登记的。
（2） The enterprise has obtained the registration of TCs or single formulation within the territory of China, and applies for registration of different content and different formulation type of the single formulation with the same active ingredient,.

（三）本企业在境内已取得混配制剂登记，申请相同有效成分不同含量、不同配比、不同剂型的混配制剂登记的。
（3） The enterprise has obtained the registration of ready-mixtures within the territory of China, and applies for registration of different contents and different formulation types of the ready-mixture with the same active ingredients,.

混配制剂有效成分数量超过《农药登记管理办法》第八条有关规定的，超过的有效成分应在境内取得登记。

If the number of active ingredients in the ready-mixture exceeds the relevant provisions of Article 8 of the “Measures on the Management of Pesticide Registration”, the exceeding active ingredients shall be registered within the territory of China.

（四）新农药原药生产企业申请原药及其制剂登记的。
（4） The enterprise that produces the new pesticide applies for the TC and its formulation registration.

（五）农业农村部规定的其他情形。
（5） Other conditions prescribed by the Ministry of Agriculture and Rural Affairs.

二、申请仅限出口非新农药登记的资料要求
2. Data requirements of registration application for export-only non-new pesticides.

（一）农药登记申请表（仅限出口选项）。
（1） Pesticide registration application form (select export-only option).

（二）有效的境外登记或进口国（地区）同意进口的证明文件(证明文件与申请企业名称不符的,应提供具有说服力的经营合作关系资料)。
（2） Valid documents of overseas registration certificate or import approval issued by the importing country (region) (if the name of the application enterprise in the documents are inconsistent, persuasive materials of business cooperation shall be provided).

（三）企业不在境内销售使用等承诺书（法人代表签字并加盖企业公章）。
（3）Letter of commitment that enterprise does not sell or use the export-only pesticides in China (signed by the legal representative and stamped with the seal of the enterprise).

（四）产品概述、境外登记资料摘要、原药来源情况说明等相关材料。
（4） Product overview, summary of overseas registration data, description of TC source and other relevant materials.

（五）产品化学资料（产品质量标准、质量检测报告，原药还应提供全组分分析报告）和毒理学试验资料（急性经口、经皮、吸入毒性试验报告），及中毒症状、急救及治疗措施资料。
（5） Product chemical data (product quality standard, quality test report, TC shall also provide the full component analysis report), toxicology test data (acute oral, dermal, inhalation toxicity test report), poisoning symptoms, first aid and treatment measures.

（六）与申请产品生产范围相符合的农药生产许可证复印件。
（6） A copy of the pesticide production license in line with the production scope of the product applied for.

三、申请仅限出口新农药登记的资料要求
3. Data requirements of registration application for export-only new pesticides.

申请仅限出口新农药原药登记的，除提供非新农药登记的资料（一）至（五）项要求外，还应当提供下列资料：

Where to apply for registration application of export-only new pesticide, in addition to the items (1) to (5) of application requirements for export-only non-new pesticides , the following information shall also be provided:

（一）有效成分和原药的理化性质资料，以及标准品。
（1） The physical and chemical properties data of the active ingredient and the TC, as well as the standard substance.

（二） 原药的皮肤刺激性、眼睛刺激性、皮肤致敏性、急性神经毒性、亚慢性经口毒性、亚慢（急）性经皮和吸入毒性、致突变性、致畸性、两代繁殖毒性、慢性和致癌性、代谢和毒物动力学等试验的摘要或查询资料。
（2）Abstract or inquiry data of skin irritation, eye irritation, skin sensitization, acute neurotoxicity, subchronic oral toxicity, subchronic (acute) dermal and inhalation toxicity, mutagenicity, teratogenicity, two generation reproductive toxicity, chronic and carcinogenicity, metabolism and toxicokinetics of the TC.

（三） 原药的环境影响和安全生产评价批复文件复印件。
（3） Copies of the approval documents for the environmental impact and safety production evaluation of the TC.

申请仅限出口新农药制剂登记的，按非新农药登记要求提供资料。

Where to apply for the registration of export-only new pesticide formulation, the data shall be provided according to the application requirements for export-only non-new pesticide

四、其他
4、 Others

（一）  仅限出口农药按农药登记、登记变更、登记延续申请和审批程序办理，其农药登记证编号代码为“EX+年份+序列号”，如EX20200001。农药登记证上注明“仅限出口”。
（1）Export-only pesticides shall be supervised with the procedures of pesticide registration, registration change, registration renew application and data review, and its pesticide registration certificate number code is "EX + year + serial number", such as EX20200001. "Export-only" is indicated on the pesticide registration certificate.

（二）已有相同制剂、相似制剂在境内取得登记的，不再批准该农药产品仅限出口登记，对已批准的申请登记延续不超过1次。
（2） Where the same or similar formulations have been registered within the territory of China, the pesticide product shall not be approved for export-only, and for those already approved, registration application for export-only shall not be renewed more than once.

（三）申请仅限出口母药登记的，应当是该母药的原药生产企业，资料要求与制剂相同。
（3） The enterprise applies for registration of export-only TK, it shall be the TC production enterprise of the applied TK, and the data requirements shall be as same as those of the formulation.

（四）取得仅限出口新农药原药登记的，取得相应的生产许可后方可生产出口。
（4） Where the registration of export-only new pesticide is approved, it can be produced and exported after obtaining the corresponding production license.

（五）仅限出口农药产品只能出口到取得境外登记或同意进口的国家（地区）。
（5） Export-only pesticide products can be exported to the countries (regions) where they have obtained the registration certificates or import approvals.

（六）禁止在我国境内销售仅限出口农药产品，违者按照《农药管理条例》未取得境内使用登记有关规定查处。
（6） It is prohibited to sell export-only pesticide products in China. If it’s found violating the rules, it shall be punished pursuant to the Regulations on the Management of Pesticides with the relevant provisions of not obtaining the registration of domestic use.

（七）本公告自发布之日起实施。
（7） This announcement shall be implemented as of the date of promulgation.

农业农村部
Ministry of Agriculture and Rural Affairs
2020年6月8日
June 8, 2020