Chinese Ministry of Agriculture and Rural Affairs issues implementation details on export-only pesticide registration process
Oct. 30, 2020
The Chinese Ministry of Agriculture and Rural Affairs, on October 26, issued implementation details following the issuance of the Announcement No. 269 by the Ministry of Agriculture and Rural Affairs.
The implementation provides a guideline for pesticide manufacturers and agricultural administrations concerning registration and management of export-oriented pesticides, to correctly and properly observe the requirement of the Announcement No. 269 by the ministry.
1.Scope of export-only pesticide registration
1)Concerning the clause “manufacturers that have obtained the technical material registration in China applying for registration of technical material with the same active ingredient but different content”, it is applicable to the technical concentrate without technical material registration.
2)Concerning the clause “novel technical material manufacturers applying for registration of technical material and formulation” (1) novel pesticide technical and formulation registration can be applied for at the same time, or technical material be applied for first, followed by the application for formulation (2) manufacturers that have obtained registration of export-only novel pesticide technical can apply for export-only registration of single agent or mixture containing the active ingredient according to the novel pesticide formulation registration requirement, providing that the other active ingredients in the mixture have been registered in China (3) if a pesticide is registered in China but no such product is still valid, the technical material manufacturer can apply for export-only registration with reference to the novel pesticide requirement.
2.Data requirement on registration of export-only non-novel pesticides
1)Concerning the clause “valid overseas registration or import country/region’s import approval documents (in case of the approved name being inconsistent with the name of the applicant, a convincing business relationship proof shall be provided)” (1) “approval documents” refer to the copy of an overseas registration certificate or an import license issued by the overseas agricultural administration department; a registration certificate shall be attached with a label (2) if the applicant is a supplier to the holder of the overseas pesticide registration certificate or import license, which is, however, not indicated in the overseas registration certificate or import license, then a certification needs to be issued by the pesticide administration department or a notary organ of the country/region where the overseas registration or import license is granted. A certification can also be processed through the procedure agreed upon under the relevant treaties between China and the involved country/region. In addition, the supply contract or agreement signed between the applicant and the holder of the overseas registration certificate or import license shall be provided.
2)Concerning the clause “product chemical data (product quality standard, quality test report, full component analysis report in case of technical material) and toxicological test data (acute oral, skin, inhalation toxicity test report), as well as toxic symptom, first aid and treatment measures” (1) the "test report" and testing qualification requirements are identical to the Chinese domestic registration requirements. For overseas GLP reports that meet the requirements, the transitional policy of registration data shall be applicable by the end of 2020 (2) “toxic symptom, first-aid and treatment measures” can be referenced by the searched information.
1)Concerning the clause “export-only pesticides shall be processed according to the pesticide registration, registration change, registration renewal application and approval procedures" (1) the registration procedure is consistent with the relevant provisions of Chinese domestic pesticide registration procedure, where the processing time limit is 20 working days (technical review shall not exceed six months) (2) export-only pesticides registered shall be reviewed at the executive member meeting of the National Pesticide Registration Evaluation Committee (3) an export-only pesticide registration certificate is valid for five years (4) in case of changes of export-only pesticide in countries/regions where the registration is granted, registration change can be applied for (5) application for renewal of export-only pesticide registration requires checking of changes of the registration at home and abroad.
2)Concerning the clause “in case that same formulation or similar formulation is already registered in China, no export-only pesticide registration shall be granted; and renewal of approved registration shall not be more than once” (1) after a novel pesticide is granted registration in China, pesticides containing the active ingredient of other manufacturers will not be approved for the export-only purpose, whilst the approved export-only registration can be extended only once (2) after the registration of non-novel similar formulation is granted in China, the export-only registration of the pesticide will be no longer approved; the approved export-only pesticide is allowed for renewal only once.
3)Paraquat, which is registered exclusively for export, will be registered as an export item only at the time of renewal of registration.
4)In terms of the high-toxic and extreme-toxic pesticides which shall not be newly registered, no export-only registration shall be approved. Regarding the pesticides prohibited or restricted in China, the prohibition and restriction regulation shall be strictly observed.
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