A Detailed Comparative Analysis of the Provisions Before and After the Revision of the Measures for the Administration of Pesticide Registration

On January 7, 2022, Minister of Agriculture and Rural Affairs Tang Renjian signed Ministry Order No. 1 of 2022, promulgating the “Decision of the Ministry of Agriculture and Rural Affairs on Amending and Repealing Certain Regulations and Normative Documents” (hereinafter referred to as the “Decision”), which took effect upon its publication. The Decision amended certain provisions of the Measures for the Administration of Pesticide Registration and the Measures for the Administration of Pesticide Registration Trials. Today, let us examine the specific amendments.

Article 4 of the Decision amends the Measures for the Administration of Pesticide Registration (promulgated by Order No. 3 of the Ministry of Agriculture on June 21, 2017, and amended by Order No. 2 of the Ministry of Agriculture and Rural Affairs on December 6, 2018). The phrase “paragraph 3” in item 5 of paragraph 1 of Article 38 is deleted.

Prior to amendment: (5) The registration trial does not comply with the provisions of Article 9, Paragraph 3, and Article 10 of the Regulations on the Administration of Pesticides;

Amended: (5) The registration trial does not comply with the provisions of Articles 9 and 10 of the Regulations on the Administration of Pesticides;

Article 5 of the Decision introduces five amendments to the Measures for the Administration of Pesticide Registration Trials (promulgated by Ministry of Agriculture Order No. 6 of 2017 on June 21, 2017, and amended by Ministry of Agriculture and Rural Affairs Order No. 2 of 2018 on December 6, 2018):

(1) Delete the phrase “Registration trials of new pesticides shall also be subject to review and approval by the Ministry of Agriculture” from paragraph 2 of Article 2.

Prior to the amendment: Applicants conducting pesticide registration trials shall file a record with the agricultural administrative department of the provincial people’s government where the trial is conducted (hereinafter referred to as the provincial agricultural department); for registration trials of new pesticides, prior review and approval by the Ministry of Agriculture are also required.

Amended: Applicants conducting pesticide registration trials shall file a record with the agricultural and rural affairs authority of the provincial people’s government where the trial is conducted (hereinafter referred to as the provincial agricultural and rural affairs department).

(2) Delete “approval of new pesticide registration trials,” from paragraph 1 of Article 3.

Prior to the amendment: The Ministry of Agriculture was responsible for approving registration trials of new pesticides, accrediting institutions conducting such trials, and supervising and managing these trials; the specific tasks were undertaken by agencies under the Ministry of Agriculture that are tasked with pesticide inspection.

Amended: The Ministry of Agriculture and Rural Affairs is responsible for the accreditation of pesticide registration‑testing institutions and the supervision and administration of registration‑testing activities; the specific tasks are undertaken by the agency under the Ministry that is tasked with pesticide inspection.

(3) Article 16 is amended to read as follows: “Prior to conducting pesticide registration trials, the applicant shall, in accordance with the procedures and requirements stipulated by the Ministry of Agriculture and Rural Affairs, file a record with the provincial agricultural and rural affairs department where the trial is conducted through the China Pesticide Digital Supervision and Management Platform. The recorded information shall include the filing entity, the name of the active ingredient, its content and formulation, the trial items, the trial location, the testing institution, the year the trial commenced, the commissioned agreement signed with the testing institution, and safety precautions, among other details. For new‑pesticide registration trials, the record shall also include the mode of action and mechanism of action.”

Prior to conducting pesticide registration trials, the applicant shall file a record with the provincial agricultural authority where the trial is to be conducted. The filing shall include information on the filer, a product overview, the trial items, the trial location, the testing institution, the trial duration, and safety precautions, among other details.

Amended: Prior to conducting pesticide registration trials, the applicant shall, in accordance with the procedures and requirements stipulated by the Ministry of Agriculture and Rural Affairs, file a record with the provincial agricultural and rural affairs department where the trial is conducted through the China Pesticide Digital Supervision and Management Platform. The filing information shall include the filing entity, the name of the active ingredient, its content and formulation, the trial items, the trial location, the testing institution, the year the trial commenced, the commissioned agreement signed with the testing institution, and safety precautions, among other details. For new‑pesticide trials, the filing must also specify the mode of action and mechanism of action.

(4) Articles 17, 18, 19, and 20 are deleted.

Prior to amendment: Article 17. Any entity intending to conduct registration trials for a new pesticide shall submit an application to the Ministry of Agriculture and provide the following materials: (1) Application Form for Registration Trials of New Pesticides; (2) Information on domestic and international research and development, as well as overseas registration status; (3) Scope of the trials, trial locations (trial areas), and relevant explanatory notes; (4) Chemical information on the product and a report on the conformity of product quality; (5) Toxicological information; (6) Crop‑safety information; (7) Environmental safety information; (8) Existing or potential safety hazards during the trial process; (9) Safety precautions required during the trial; and (10) Documents proving the applicant’s identity. The application materials shall be submitted in both paper form and electronic format.

Article 18. The Ministry of Agriculture shall, in accordance with the following circumstances, take the appropriate action with respect to the application materials submitted by the applicant: (1) Where no approval is required for pesticide registration trials, the applicant shall be promptly notified that the application will not be accepted; (2) If there are errors in the application materials, the applicant shall be permitted to correct them on the spot; (3) If the application materials are incomplete or do not conform to the statutory form, the applicant shall be informed, either on the spot or within five working days, of all the items that need to be supplemented; if such notification is not provided within the prescribed time limit, the application shall be deemed accepted as of the date of receipt of the materials; (4) If the application materials are complete and conform to the statutory form, or if the applicant submits all the supplementary materials as required, the application shall be accepted.

Article 19 The Ministry of Agriculture shall, within forty working days from the date of acceptance, review the safety risks of the trial and the corresponding preventive measures, and render an approval decision. If the conditions are met, registration of the trial shall be approved, and a Certificate of Approval for New Pesticide Registration Trials shall be issued; if the conditions are not met, the applicant shall be notified in writing, with reasons provided.

Article 20 The approval certificate for new pesticide registration trials shall specify the applicant, the name of the pesticide, the formulation type, the active ingredient and its content, the scope of the trial, the trial certificate number, and the validity period, among other particulars.

The format of the Approval Certificate for New Pesticide Registration Trials is prescribed by the Ministry of Agriculture. The certificate number follows the “SY + year + serial number” scheme, where the year is represented by a four-digit Arabic numeral indicating the year of issuance, and the serial number consists of three Arabic numerals.

The approval certificate for new pesticide registration trials is valid for five years. If no trials are conducted within that period, a new application must be submitted.

(5) Delete the following provision from paragraph 1 of Article 25: “For new pesticides, a copy of the approval certificate for the registration trial of the new pesticide shall also be submitted.”

Prior to amendment: Applicants shall provide the pesticide registration test institution with information on the test sample, including its name, active ingredient content, formulation, date of manufacture, storage conditions, shelf life, and safety risk mitigation measures. For new pesticides, applicants must also submit a copy of the approval certificate for the new‑pesticide registration test.

Amended: The applicant shall provide the pesticide registration test institution with information on the test sample, including the pesticide name, active ingredient content, formulation type, date of manufacture, storage conditions, shelf life, and safety risk mitigation measures.

Source: Huisheng Pesticide Registration Agency