The Ministry of Agriculture and Rural Affairs has issued a statement clarifying the details of its policy on pesticide registration for export only.

On October 26, in order to ensure accurate compliance with the requirements of Ministry of Agriculture and Rural Affairs Announcement No. 269 and to guide pesticide manufacturers and agricultural and rural affairs authorities in carrying out registration and management services for pesticides intended solely for export, the Pesticide Management Division of the Ministry of Agriculture and Rural Affairs issued a detailed explanation of Announcement No. 269.

I. Scope of Registration for Pesticides Restricted to Export Only

(1) Explanation for “This enterprise has already obtained active‑ingredient registration within China and is applying for active‑ingredient registration for the same active ingredient at a different concentration”: This item applies to parent compounds that do not yet have active‑ingredient registration.

(2) Explanation regarding “Applications by New Active‑Ingredient Manufacturers for Registration of Both the Active Ingredient and Its Formulations”: First, new active ingredients and formulations may be registered simultaneously, or the manufacturer may first seek registration of the active ingredient and subsequently apply for formulation registration. Second, enterprises that have obtained registration for new active ingredients solely for export may, in accordance with the requirements for new‑type formulations, apply for registration of single‑ingredient or mixed‑formulation products containing that active ingredient, provided such products are restricted to export; any other active ingredients in the mixed formulation must already be registered within China. Third, manufacturers that previously held domestic pesticide registrations but no longer have products under valid registration may, by analogy with the requirements for new pesticides, apply for export‑only registration.

II. Requirements for Documentation in Applications Limited to the Export of Non‑Newly Registered Pesticides

(1) Explanation regarding “valid overseas registration or proof of import approval from the importing country (or region) (if the name on the supporting document does not match that of the applying enterprise, supporting documentation demonstrating a credible business partnership must be provided):” First, “supporting documents” refer to a copy of the overseas registration certificate or a copy of the import authorization issued by the foreign pesticide regulatory authority; the registration certificate must be accompanied by its label. Second, if the applicant is a supplier to the holder of an overseas pesticide registration certificate or import authorization, but such certificate or authorization does not explicitly list the applicant, additional certification or notarization from the pesticide regulatory authority of the country (or region) where the registration or import authorization was obtained, or compliance with the evidentiary procedures stipulated in any relevant treaties concluded between China and that country (or region), shall also be required. Furthermore, the applicant must submit a supply contract or agreement entered into with the holder of the overseas registration certificate or import license.

(2) Explanation regarding “Product Chemistry Data (including product quality standards and quality‑testing reports; for technical-grade active ingredients, a full‑component analysis report must also be provided) and Toxicology Test Data (including acute oral, dermal, and inhalation toxicity test reports), as well as information on poisoning symptoms, first‑aid measures, and treatment protocols”: First, the requirements for “test reports” and the qualifications of testing institutions are consistent with domestic registration requirements. Foreign GLP‑compliant test reports that meet the stipulated criteria will be subject to the transitional policy for registration dossiers until the end of 2020. Second, “information on poisoning symptoms, first‑aid measures, and treatment protocols” may be submitted in the form of referenced documentation.

III. Other Requirements

(1) Explanation of “Export‑Only Pesticides: Registration, Registration Amendments, and Renewal Shall Be Processed in Accordance with the Relevant Procedures”: First, the registration procedures for export‑only pesticides are consistent with the relevant provisions governing domestic pesticide registration, with a processing period of 20 working days (the technical review shall not exceed six months). Second, applications for the registration of export‑only pesticides are reviewed by the Executive Committee of the National Pesticide Registration Review Committee. Third, the validity period of the registration certificate for export‑only pesticides is five years. Fourth, if the countries (or regions) where an export‑only pesticide is registered abroad change, an application for a registration amendment may be submitted. Fifth, when renewing the registration of an export‑only pesticide, it is necessary to verify any changes in the product’s registration status both domestically and internationally.

(2) Explanation regarding the provision that “where an identical or similar formulation has already obtained registration within China, no further approval shall be granted for export‑only registration of that pesticide product; and for applications already approved, a single renewal of registration may be permitted”: First, once a new pesticide has obtained domestic registration, no additional export‑only registrations shall be approved for products containing the same active ingredient manufactured by other enterprises; however, existing export‑only registrations may be renewed once. Second, for non‑new pesticides—i.e., similar formulations that have already obtained domestic registration—no further export‑only registrations shall be approved; and such previously approved export‑only registrations may be renewed once.

(3) Paraquat and other products originally registered exclusively for export shall, upon renewal of their registration, be reclassified as export‑only registrations.

(4) In accordance with national regulations, highly toxic or acutely toxic pesticides that are not newly registered domestically shall not be granted export‑only registration. Pesticide products prohibited or restricted for use in China shall be strictly managed in compliance with the requirements set forth in the relevant prohibition and restriction notices.

Source: Pesticide Management Division, Ministry of Agriculture and Rural Affairs