China is the world's largest exporter of pesticides. Stabilizing China's pesticide exports not only affects the sound operation of the domestic pesticide industry, but also an important support for stabilizing global grain production. The Ministry of Agriculture and Rural Affairs has recently adjusted its export policies on the basis of listening to multiple opinions.
New Regulations on the Registration of Exported Pesticide Products
On June 9th, in order to implement the spirit of the State Council's "Release Control" reform, promote the export of pesticides, and optimize the business environment, the Ministry of Agriculture and Rural Affairs did not apply for the registration of exported pesticides (referred to as "exported pesticides only") products not used in China Issue No. 269 Announcement. The announcement states:
According to the "Pesticide Management Regulations" and "Pesticide Registration Management Measures", the relevant matters concerning product registration for export pesticides (referred to as "export pesticides only") not used in my country are as follows:
1. The application is limited to the scope of export pesticide registration
Products that obtain pesticide registration abroad or obtain import licenses from importing countries (regions) meet one of the following conditions, and pesticide production enterprises may apply for registration of export-only pesticides.
(1) The enterprise has obtained the registration of the original drug within the territory of the country and is applying for the registration of the original drug with the same effective ingredient and different content.
(2) The enterprise has obtained the registration of the original drug or single preparation within the territory of China, and has applied for the registration of the single preparation of the same active ingredient with different contents and different dosage forms.
(3) The enterprise has obtained the registration of mixed preparations within the territory of China and applied for the registration of mixed preparations with different contents, different ratios and different dosage forms of the same active ingredient.
If the number of active ingredients in a compound preparation exceeds the relevant provisions of Article 8 of the "Administrative Measures on Pesticide Registration", the excess active ingredients shall be registered within the territory.
(4) A new pesticide and original medicine manufacturer applies for registration of original medicine and its preparations.
(5) Other circumstances prescribed by the Ministry of Agriculture and Rural Affairs.
Second, the application is limited to the export of non-new pesticide registration data requirements
(1) Pesticide registration application form (export option only).
(2) Valid overseas registration or certification documents of the importing country (region) agreeing to import (if the certification documents do not match the name of the applying enterprise, it should provide persuasive business cooperation information).
(3) Commitment letter for non-sale, use, etc. of the enterprise (signed by the legal representative and affixed with the company's official seal).
(4) Product overview, summary of overseas registration data, explanation of the origin of the original drug and other relevant materials.
(5) Product chemical information (product quality standards, quality test reports, and full-component analysis reports should also be provided for the original drug) and toxicology test data (acute oral, transdermal, and inhalation toxicity test report), as well as symptoms of poisoning and first aid And treatment information.
(6) A copy of the pesticide production license that conforms to the scope of the product being applied for.
3. Data requirements for registration of new pesticides for export only
If the application is limited to the registration of new pesticides and original medicines, in addition to the requirements for the registration of non-new pesticides (1) to (5), the following materials shall also be provided:
(1) Information on the physical and chemical properties of the active ingredients and the original drug, as well as standard products.
(2) Skin irritation, eye irritation, skin sensitization, acute neurotoxicity, subchronic oral toxicity, subchronic (acute) percutaneous and inhalation toxicity, mutagenicity, teratogenicity, Summary or query data of generation reproductive toxicity, chronic and carcinogenicity, metabolism and toxicokinetics.
(3) Copy of the approval documents for the environmental impact of the original drug and the safety production evaluation.
If the application is limited to the registration of new pesticide formulations for export, information shall be provided in accordance with the registration requirements for non-new pesticides.
4. Other
(1) Only pesticides for export are handled in accordance with pesticide registration, registration change, registration continuation application and approval procedures, and the pesticide registration certificate number code is "EX+year+serial number", such as EX20200001. The pesticide registration certificate states "export only".
(2) If the same preparation or a similar preparation has been registered in the territory, the pesticide product shall no longer be approved for export registration only, and the registration of the approved application shall be continued no more than once.
(3) If the application is limited to the registration of the export parent drug, it should be the original drug manufacturer of the parent drug, and the information requirements are the same as the preparation.
(4) If the registration of new pesticides and original medicines for export is obtained, the production license can be produced before export.
(5) Only export pesticide products can only be exported to countries (regions) that have obtained overseas registration or agreed to import.
(6) It is forbidden to sell pesticide products in my country only for export. Offenders have not been investigated and dealt with in accordance with the Regulations on Pesticide Management.
(7) This announcement will be implemented as of the date of its release.
Ministry of Agriculture and Rural Affairs
June 8, 2020
Encouraging the export of enterprises by opening up industry plugs will help to promote the negative growth of pesticide use in China, and help enterprises to embark on an international road.
