Newsletter Issue 3, 2019

 

 

  Opinions of the Central Committee of the CPC and

  the State Council on Deepening the Reform and

  Strengthening Food Safety

 

 

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.
I. Scope of registration application for export-only pesticides
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).
(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.
(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,.
(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,.
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.
(4) The enterprise that produces the new pesticide applies for the TC and its formulation registration.
(5) Other conditions prescribed by the Ministry of Agriculture and Rural Affairs.
II. Data requirements of registration application for export-only non-new pesticides.
(1) Pesticide registration application form (select export-only option).
(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).
(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).
(4) Product overview, summary of overseas registration data, description of TC source and other relevant materials.
(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.
(6) A copy of the pesticide production license in line with the production scope of the product applied for.
III. Data requirements of registration application for export-only new pesticides.
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:
(1) The physical and chemical properties data of the active ingredient and the TC, as well as the standard substance.
(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.
(3) Copies of the approval documents for the environmental impact and safety production evaluation of the TC.
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
IV. Others
(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.
(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.
(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.
(4) Where the registration of export-only new pesticide is approved, it can be produced and exported after obtaining the corresponding production license.
(5) Export-only pesticide products can be exported to the countries (regions) where they have obtained the registration certificates or import approvals.
(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.
(7) This announcement shall be implemented as of the date of promulgation.

Ministry of Agriculture and Rural Affairs
June 8, 2020   

 

 

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