China’s Restricted-Use Pesticide Registration Q&A: A total of 361 registrations have been granted from 2020 to the present.

China’s policy on export‑only pesticide registration has undergone continuous revisions over the past decade and more, evolving 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 after 2014, and finally culminating in the long‑awaited export‑only pesticide registration policy and its accompanying implementation guidelines, which were promulgated in 2020.

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,” such as EX20200001, and the certificate explicitly states “For Export Only.”

04 What are the prerequisites for applying for export‑only 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: A pesticide manufacturer may apply for export‑only registration if it meets 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 at different concentrations, with different ratios, or in different dosage forms: if the number of active ingredients in the mixed formulation exceeds the limits set forth in Article 8 of the Measures for the Administration of Pesticide Registration, any additional active ingredients must also be 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 repeated here.

07 For export only: Which websites’ toxicological data on new pesticide active ingredients are recognized for submission?

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 relevant organizations. 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 noted when applying for the export of new active‑ingredient pesticide technicals (parent compounds)?

Answer: When applying for export‑only registration of a new active ingredient in the form of the technical material (parent compound), 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 active ingredients intended for public health applications, most other technical‑material products are not required to provide sub‑acute or chronic inhalation toxicity data. Therefore, manufacturers seeking export‑only registration for 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 technicals (active ingredients) intended solely for export, can registration 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 a new pesticide intended solely 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 material, or simultaneously apply for registration of both the technical material 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 abroad includes information on 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, are they eligible for exemption from inhalation toxicity testing?

Answer: For the conditions under which inhalation toxicity testing may be exempted for export‑registered products, please refer to the exemption criteria for inhalation toxicity testing applicable to formally registered products as specified in the pesticide registration data requirements.

13. If the overseas registration certificate does not specify its validity period, what should be submitted when it is intended for export only?

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

For example: In the U.S., if a product is not registered and the registration approval notice does not specify a product expiration date, the U.S. registration remains valid only upon annual payment of the renewal fee. Therefore, an explanatory statement along with the relevant supporting documentation must be submitted concurrently.

WeChat Official Account: Agrochemical Regulations Service Station