China release new regulation on pesticide for export, providing more certainty and convenience to global agricultural supply chain

On November 4, Ministry of Agriculture and Rural Affairs of China()MARA) circulated a letter seeking industry opinion on regulation of Pesticide Registration for Overseas use only( EX Registration )″ in order to formulate a new regulation on registration of export-only pesticides. Compared with the previous revision, the new regulation aims at further process simplification and standard clarification, which will provide more certainty and convenience to global importers that rely on Chinese pesticide products.

Highlight：

• The term "For Export Only" has been renamed to "For Overseas Use Only (EX Registration)."

• Application requirements: The application conditions for formulations have been relaxed. As long as the active ingredient has already been registered domestically, applicants can apply for EX Registration for single or mixed formulations.

• Reduced data requirements: Significantly lower data requirements for new active ingredients, particularly toxicology data. Toxicology data for Technical Concentrate and formulation are exempted.

• Strengthened linkage with production permits: Clearly requires a copy of the pesticide production license to be provided, replacing the previously required copies of environmental impact and safety assessments for technical-grade material.

The details of the new regulation that is seeking industry feedback are as follows:

1. Pesticide manufacturers in possession of supportive documents that allow for overseas use of their products may apply for EX Registration of pesticide, subject to compliance to one of the following requirements:

1) In case that an active ingredient is not registered for use in China, the applicant may simultaneously apply for EX Registration of Technical Material (TC)/Technical Concentrate(TK ) and formulation, or may first apply for EX Registration of TC/TK, then apply for EX Registration of formulation.

2) In case that an active ingredient is already approval as TC in China, the applicant may apply for EX Registration of TC/TK with different content based on the active ingredient; or in case of active ingredient is already approval as TK in China, the applicant may apply for EX Registration of TK with different content based on active ingredient.

3) In case that an active ingredient is already registered for use in China, the applicant may apply for EX Registration of a single formulation based on the active ingredient or a mixture formulation containing the active ingredient, being lifted out of the restrictive provision of the Article 8 of the Regulation on Pesticide Registration and the Announcement No. 345 of the Ministry of Agriculture and Rural Affairs in respect of pesticide content, ratio and quantity of active ingredient.

In case that an active ingredient is within the registration data protection period, the applicant is obliged to obtain the consent of the first registrant.

4) The rest of requirements stipulated by the Ministry of Agriculture and Rural Affairs.

2. The following documents shall be submitted when applying for EX Registration.

1) Pesticide registration application form

2) Product registration data

(1) Product profile, summary of overseas registration data, description of raw material source, and MSDS.

(2) Product chemical data

① In case of TC/TK whose active ingredient being not registered for use in China, the physical-chemical property of the active ingredient and TC/TK, 5-Batch Analysis, the naming letter about Chinese common name and standard sample shall be provided.

② In case of TC/TK whose active ingredient being already registered for use in China, the 5-Batch Analysis shall be provided; TK and formulation shall be accompanied with product quality standard and quality inspection report.

(3) Toxicology data: In case of a TC product, the toxicity test report of acute oral, acute skin and inhalation , the information on toxic symptom, first aid and treatment measures are required to be submitted; in case of TK and formulation, the information on toxic symptom, first aid and treatment measures is required to be submitted.

3) A copy of pesticide production permit (Production scope shall cover active ingredient or type of formulation).

4) Statement of undertaking for sale and use in China (Signed by legal representative and stamped with official seal of the enterprise).

5) Permit for overseas use.

(1) In case of product being regarded and regulated overseas as a pesticide, a pesticide registration certificate of the destination country (region) shall be provided; for formulation product, label shall be affixed.

In case that the applicant is a supplier to the overseas pesticide registrants, the registration proofs issued by an overseas pesticide registration authority shall be provided, or a copy of relevant supply contract and overseas notarial papers.

(2) In case of product overseas not being regarded and regulated as a pesticide , the approval of import by the destination country (region) shall be provided.

3. In case of a change of EX Registration, the Pesticide Registration Data Requirement shall apply; in case of adding export destination country (region), supportive documents proving permit for overseas use shall be submitted.

4. In case of an extension of EX Registration, the Pesticide Registration Data Requirement shall be compliance, whilst valid supportive documents proving permit for overseas use shall be submitted.

In case of an equivalence formulation for use in China, there will be no approval of EX Registration of such formulation; for those that have been approved, the registration extension is limited to only one time.

The EX Registration base on active ingredient which is not approval for use in China, the extension is limited to only one time in case of the active ingredient is granted registration for use in China, but not applicable to the first registrant of the active ingredient for use in China.

5. Miscellaneous provisions

1) The duration of review of registration and a change of registration of pesticides for overseas use only is 6 months.

2) The code number of EX Registration is ″EX + year + 4-digit serial number″; the pesticide registration certificate is marked with ″for overseas use only″ and the abbreviation of the destination country (region).

3) EX Registration products shall be exported only to the countries (regions) specified in the registration certificate, except registrations which are turned into EX Registration in accordance with a public notice.

4) EX Registration products are not allowed for consigned production; in case that an EX Registration product is used or marketed in China, the product will be deemed as a fake pesticide.

Disclaimer: This is an unofficial translation for reference only. Please refer to the original government document for authoritative content.

Source: AgroPages