The Ministry of Agriculture and Rural Affairs has issued a detailed announcement regarding the abolition of the approval requirement for new pesticide registration trials, replacing it with a filing system.

On October 16, the Ministry of Agriculture and Rural Affairs issued the following announcement regarding the abolition of the approval requirement for new pesticide registration trials, replacing it with a filing system.

In accordance with the “Decision of the State Council on Cancelling and Delegating a Batch of Administrative Licensing Items” (Guofa [2020] No. 13), approval for new pesticide registration trials has been abolished and replaced by a filing requirement. Pursuant to the relevant provisions of the Regulations on the Administration of Pesticides, the Measures for the Administration of Pesticide Registration, and the Measures for the Administration of Pesticide Registration Trials, pesticide registration trials shall be filed with the provincial agricultural and rural affairs department where they are conducted. To standardize the management of the filing of pesticide registration trials—covering both new and non‑new pesticides—the following matters are hereby announced.

I. Filing Entities: These include developers of new pesticides, pesticide manufacturers, or enterprises that export pesticides to China.

Joint trials for minor specialty crops conducted by registration‑testing entities commissioned by agricultural and rural departments at or above the provincial level, or by pesticide registration‑testing institutions, shall be filed with the lead testing entity.

II. Filing Procedures. Prior to the commencement of a pesticide registration trial, the applicant shall file with the provincial agricultural and rural affairs department where the trial is conducted via the “China Pesticide Digital Supervision and Management Platform” (https://www.icama.cn). Alternatively, filing may be submitted directly to the provincial agricultural and rural affairs department at the trial site.

III. Contents of the Filing. These include the filing entity, the names of active ingredients, their concentrations and dosage forms, the test items, the test locations, the testing institutions, the year in which testing commenced, the commissioned agreement signed with the testing institution, and safety precautions. For new pesticide trials, the filing must also specify the mode of action and mechanism of action.

The same product shall be assigned a single registration number. All test items may be registered in one submission, or registered in multiple stages. For any changes other than to the active ingredient name, content, or dosage form, the registration number remains unchanged. If a registered product undergoes a registration amendment and submits a corresponding test registration, a new registration number will be issued. In the event of cancellation of the registration, the original registration number shall be invalidated.

The filing number consists of the administrative division code of the province (autonomous region or municipality) where the filing entity is located, the date of the initial filing, the filing type code, and a sequential number.

IV. Filing Requirements. In accordance with Article 8 of the Measures for the Administration of Pesticide Registration, applications shall not be filed if the number of active ingredients exceeds the prescribed limit (except for registration trials of pesticide products intended solely for export).

For products that have completed the registration‑test filing and are conducting pesticide registration trials, if the number of active‑ingredient formulations exceeds three—whether they involve single‑component formulations with identical active ingredients and formulation types but differing active‑ingredient concentrations, or mixed‑formulation products with identical active ingredients, ratios, and formulation types but varying total active‑ingredient contents—or if there are more than three distinct ratios for a given active ingredient and formulation type, the applicant may request a change in accordance with the principle of similarity. If such a change necessitates the conduct of new trials, a new filing must be submitted.

For agricultural formulated products with identical active ingredients and formulations, in principle, if the ratio of active ingredient contents differs by less than 1 compared with a previously registered product having a similar formulation (for example, for an A·B wettable powder, where the already‑registered product 1 has an active ingredient ratio of 10:10, corresponding to a ratio of 1, and the product seeking registration 2 has an active ingredient ratio of 15:10, corresponding to a ratio of 1.5—resulting in a difference of 0.5 from product 1), such a product will not be accepted for registration (except for registration trials of export‑only pesticide products).

For tests that cannot be conducted by existing pesticide registration testing institutions, the tasks shall be undertaken by entities designated by the Ministry of Agriculture and Rural Affairs and reported in accordance with relevant regulations.

V. Other Requirements. For changes in the content of the active ingredient of a pesticide product, applicants shall submit the relevant documentation in accordance with Annex 12 of the “Requirements for Pesticide Registration Data” (Ministry of Agriculture Announcement No. 2569) when applying for pesticide product registration.

For changes to the formulation of a pesticide product, when applying for pesticide product registration, in addition to submitting the pre‑change test data, the post‑change data shall be submitted as follows:

(1) Following the change in formulation ratio, the scope of use remains identical to that of the registered product. Submission shall include an explanation of the change, chemical data for the product (with the stability‑in‑storage‑at‑room‑temperature test report and the method‑validation report permitted to be those prior to the change), and a sample label. Also required are information on the recommended application rate, application techniques, maximum number of applications, and the pre‑harvest interval, together with supporting documentation. For any changes that increase the content of the active ingredient, the corresponding acute oral, dermal, and inhalation toxicity study reports after the change must also be submitted.

(2) If, following a change in the formulation ratio, the intended use differs from that of the registered product, in addition to the materials specified in (1), a one-year efficacy trial report must also be submitted. Furthermore, if the revised formulation ratio falls outside the applicant’s laboratory‑scale formulation screening and recommendation range, an indoor bioassay report for the modified ratio shall be provided to verify its combined toxicity and suitability. Additionally, where the amended formulation entails an increased dosage or frequency of application of the active ingredient, or a shortened pre‑harvest interval, residue study data with sample sizes reduced by half must be submitted.

VI. Supervision and Management. Applications for pesticide registration that have not been filed in accordance with the requirements shall not be accepted; applications already accepted shall not be approved.

The registrant shall ensure that the risks associated with pesticide registration trials are under control.

When significant safety risks arise during pesticide registration trials, the testing institution shall immediately suspend the trial, implement appropriate measures to prevent further escalation of the risks, and report to the provincial agricultural and rural affairs authority where the trial is conducted, while also notifying the registrant.

Provincial agricultural and rural affairs authorities shall strengthen oversight and management of pesticide registration trial institutions and trial procedures. If safety risks that are difficult to control are identified during the trial process, they shall promptly order the suspension or termination of the trial and report the matter to the Ministry of Agriculture and Rural Affairs without delay.

VII. This announcement shall take effect from the date of its issuance. Those who have already completed registration in the original system are not required to re-register. For those who have completed trials but have not yet submitted a registration application, or who are conducting pesticide registration trials without having filed the requisite trial registration, supplementary registration must be submitted by April 30, 2021. Applications for pesticide registration that remain unregistered after this deadline will not be accepted.

Products that were accepted for processing prior to the issuance of this announcement shall be governed by the original regulations.

Ministry of Agriculture and Rural Affairs of the People’s Republic of China

October 16, 2020