China’s Export‑Only Pesticide Registration Q&A: A total of 361 registrations have been granted from 2020 to the present.

Over the past decade and more, China’s policy on export‑only pesticide registration has undergone continuous revisions: from the CHD export‑pesticide filing system around 2000, to an informal export‑only regime from roughly 2007 to 2014, then to the JW filing system introduced after 2014, and finally, in 2020, the long‑awaited policies and detailed procedures for export‑only pesticide registration were promulgated.

Major agrochemical companies have successively benefited from the policy allowing the export‑only registration of pesticides. Since 2020, a total of 361 export‑only pesticide products have obtained registration, with approximately 50 registrations for active ingredients and technical-grade materials and around 300 for formulated products. This article summarizes several issues that companies frequently raise, for reference by the broader industry.

01 What is an export-only pesticide?

Answer: “Exclusively for export” refers to pesticides that are not used within the territory of China.

02 What is the approval timeframe for pesticide registration solely for export?

Answer: Export‑only pesticides shall be processed in accordance with the procedures for pesticide registration, registration amendment, and registration renewal applications and approvals.

03 What is the difference between a registration certificate for export‑only pesticide registration and a full registration certificate?

Answer: The registration number for export‑only pesticide registration certificates follows the format “EX+year+serial number,” e.g., EX20200001, and the certificate explicitly states “For Export Only.”

04 What are the prerequisites for applying solely for export pesticide registration?

Answer: The prerequisite for applying for an export‑only pesticide registration is that the product in question must already have obtained pesticide registration abroad or an import authorization from the importing country (or region).

05 Which products are eligible to apply for pesticide registration restricted to export?

Answer: Pesticide manufacturers may apply for export‑only registration if they meet any one of the following conditions.

(1) 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.

(2) Where the enterprise has already obtained registration for the active ingredient or a single‑ingredient formulation within China and is applying for registration of a single‑ingredient formulation containing the same active ingredient but at different concentrations or in a different dosage form.

(3) Where the enterprise has already obtained registration for a mixed‑formulation product within China and is applying for registration of a mixed‑formulation product containing the same active ingredient but with different concentrations, ratios, or dosage forms, any active ingredients exceeding the limits set forth in Article 8 of the Measures for the Administration of Pesticide Registration shall have been registered within China.

(4) New active‑ingredient manufacturers applying for registration of both the active ingredient and its formulated products.

(5) Other circumstances as prescribed by the Ministry of Agriculture and Rural Affairs.

06 What are the documentation requirements for export only?

Answer: Detailed data requirements are set forth in Announcement No. 269 of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China; they will not be reiterated here.

07 For export‑only new active‑ingredient pesticide toxicology data, which websites’ information is recognized?

Answer: In August 2022, the Department of Crop Production of the Ministry of Agriculture and Rural Affairs announced that, to standardize the submission of toxicological data for applications for new pesticide registrations limited to export, applicants may submit data published on the official websites of JMPR, EFSA, USEPA, and other recognized bodies. If such official data cannot be provided, a toxicological test report must be submitted; this report shall comply with Article 16 of the Measures for the Administration of Pesticide Registration and shall be issued by a registration‑testing institution accredited by the Ministry of Agriculture and Rural Affairs or by an overseas laboratory that has signed a mutual recognition agreement with China.

08 What aspects should be taken into account when applying for the export of new active‑ingredient technical grade (parent compound) pesticides?

Answer: When applying for registration of a new active‑ingredient technical material (parent compound) restricted to export, it is necessary to submit summaries or reference materials of all toxicological data for that technical material. However, under the regulatory requirements of other countries, with the exception of certain technical materials intended for public health uses, most other technical‑grade products are not required to provide sub‑acute or chronic inhalation toxicity data. Therefore, manufacturers seeking registration solely for export of a new active ingredient should carefully assess whether they need to complete sub‑acute and chronic inhalation toxicity testing domestically.

09 For the registration of new pesticide technical-grade (parent) materials intended solely for export, can registrations be approved for multiple manufacturers?

A: If an enterprise has obtained an EX for a particular new pesticide, other enterprises may no longer apply for an EX for that product; however, they may at any time apply only for domestic registration of the same product. Where the approval for the new pesticide is limited to export‑only registration, applications already submitted to the Ministry of Agriculture and Rural Affairs for export‑only registration shall be reviewed and approved in accordance with the procedures for export‑only registration of new pesticides.

10 Can only newly developed pesticides intended for export apply separately for active ingredient registration?

Answer: For newly developed pesticides intended for export only, applicants may file a separate registration application for the technical-grade active ingredient, or they may simultaneously apply for registration of both the technical‑grade active ingredient and the formulated product exclusively for export.

11 The holder of the overseas registration certificate is not a domestic manufacturer; however, a domestic manufacturer has registered as a supplier. May the domestic manufacturer apply for an export‑only registration?

Answer: There are three scenarios:

In the first scenario, the registration certificate issued overseas lists a domestic manufacturer as the supplier; in such cases, the domestic manufacturer may apply for an export‑only registration. Examples include registration certificates from countries like Brazil, Thailand, and Japan.

The second scenario is when the overseas registration certificate does not list a domestic manufacturer as a supplier. In such cases, the domestic manufacturer must provide documentation confirming that it is a supplier to the holder of the overseas registration certificate before it may apply for an export‑only registration.

For example: The U.S. registration certificate does not list the supplier information, but the Confidential Statement of Formula included in the submitted documents does contain such information. Therefore, when submitting for export‑only purposes, please be sure to include this document.

Third, if neither of the above two situations applies, provide supporting documentation such as the cooperation agreement between the two parties.

12 For products subject only to export registration, can the inhalation toxicity test be exempted?

Answer: With respect to the conditions for exemption from inhalation toxicity testing for export‑registered products, please refer to the exemption criteria for inhalation toxicity testing applicable to officially registered products as specified in the pesticide registration data requirements.

13. The overseas registration certificate does not specify its validity period. What should be done if it is submitted solely for export purposes?

Answer: If the foreign registration certificate does not specify its validity period, a supplementary statement shall be submitted, taking into account the regulatory requirements of the relevant foreign country, to demonstrate that the certificate remains valid.

For example: The U.S. registration does not include a registration certificate, and the notice of registration approval does not specify a product’s expiration date. However, the U.S. registration remains valid only if the annual fee is paid each year; therefore, an explanatory statement along with the relevant supporting documentation must be submitted concurrently.

WeChat Official Account: Agrochemical Regulations Service Station