Detailed Summary: Key Changes in the Draft Amendment to the Measures for the Administration of Pesticide Registration

On May 12, 2023, the Pesticide Management Division of the Ministry of Agriculture and Rural Affairs issued Letter No. 34 (2023) on Public Solicitation of Comments on the Draft Amendment to the Measures for the Administration of Pesticide Registration, which has drawn significant attention from pesticide‑producing enterprises.

By comparing the “Measures for the Administration of Pesticide Registration (Draft for Public Comment)” with the Measures for the Administration of Pesticide Registration (revised by Ministry of Agriculture and Rural Affairs Order No. 1 of 2022, dated January 7, 2022), this document objectively lists and explains the key changes to the regulations, providing a basis for enterprises to conduct comparative analysis.

NO.1 Chapter 2: Basic Requirements, with the addition of Article 7:

Pesticide registration covers both technical-grade active ingredients (parent compounds) and formulated products.

Applications for the registration of active ingredients (parent compounds) shall be accompanied by the relevant pesticide production license, except in the case of new pesticides.

For applications to register pesticide formulations, the active ingredient(s) used must be products that have obtained pesticide registration and are legally manufactured.

Except in any of the following circumstances:

(1) Applications for the registration of new pesticide formulations;

(2) Where the same applicant simultaneously applies for both the active ingredient (parent compound) and the formulation registration;

(3) Those exempted from active ingredient (parent compound) registration as stipulated by the Ministry of Agriculture and Rural Affairs.

NO.2 Chapter 2: Basic Requirements, Article 9 has been amended to include:

Insect pheromone‑based attractant‑kill and confusion products may be registered based on their actual active ingredients.

NO.3 Chapter III: Application and Acceptance, with the addition of Article 16:

The applicant shall designate a registration officer responsible for the unit’s pesticide registration-related activities. The registration officer shall possess the requisite professional expertise and be familiar with the regulations and technical requirements governing pesticide registration. The applicant shall bear responsibility for the registration officer’s actions in connection with pesticide registration.

The registration officer shall be an employee of the entity. If the applicant must entrust another party to handle the application, a power of attorney specifying the particular matters entrusted shall be submitted. The applicant shall report the registration officer’s information to the Ministry of Agriculture and Rural Affairs and the provincial agricultural and rural affairs authorities, and shall promptly update such information in the event of any changes.

Agents (or agencies) shall not engage in or interfere with pesticide registration testing activities, nor shall they hold equity interests or exercise controlling ownership in pesticide registration testing entities.

NO.4 Chapter III, “Application and Acceptance,” originally Article 15, is now Article 17, with the following additions:

When submitting foreign-language materials, a Chinese translation shall be provided concurrently.

NO.5 Chapter 3, “Application and Acceptance,” originally Article 16, now Article 18 (see the figure below for details), has been amended to include:

For new pesticides that urgently require accelerated registration to control and prevent plant diseases and pests, the Ministry of Agriculture and Rural Affairs may, following expert evaluation, accept test reports issued by relevant overseas laboratories, provided they meet the applicable requirements for pesticide registration management.

No. 6 Chapter III: Application and Acceptance, with the addition of Article 20:

For applications for the registration of the same active ingredient, the same formulation, or a similar formulation, the reference product must already have obtained pesticide registration at the time of filing the pesticide registration trial record.

NO.7 Chapter III, Application and Acceptance, originally Article 18, has been split into “Article 21” and “Article 22.” Article 21 has been amended to include:

Complete registration dossiers that meet the registration data requirements and are independently owned by the holder of a pesticide registration certificate may be licensed for use by other applicants. For the same pesticide active ingredient, if cumulative testing has been conducted at three or more different testing facilities, the chronic toxicology and metabolite toxicology study data may be licensed separately. The total licensing fees charged to a single data owner shall not exceed 70% of the aggregate cost of the studies underlying the licensed data.

When toxicological studies on the same active ingredient have been conducted cumulatively at three or more different testing facilities, a reduction or exemption may be requested upon approval by the Pesticide Registration Review Committee.

NO.8 Chapter 3, “Application and Acceptance,” originally Article 19, now Article 23 (see the figure below for details), has been revised and improved:

The Ministry of Agriculture and Rural Affairs or the provincial agricultural and rural affairs department shall conduct a formal review of the application materials submitted by the applicant and accept applications that meet the requirements. Applications shall not be accepted in any of the following circumstances:

(1) Those that do not fall within the scope of pesticide registration;

(2) The pesticide for which registration is sought is one that has been expressly prohibited from production, marketing, or use by the relevant state authorities, or for which the Ministry of Agriculture and Rural Affairs has, in accordance with the law, ceased to grant new registrations.

(3) Where the application materials are incomplete or contain errors and have not been supplemented within the prescribed time limit;

(4) The applicant does not meet the eligibility requirements set forth in Article 14 of these Measures;

(5) The applicant has been included on the list of seriously untrustworthy entities prescribed by the relevant state authorities and is subject to restrictions on obtaining administrative licenses;

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

(7) Repeated applications.

NO.9 Chapter III: Application and Acceptance, with the addition of Article 24:

Applications for pesticide registration shall be submitted in a single submission, in accordance with the requirements for pesticide registration dossiers. Once the application has been accepted, no additional materials may be submitted by the applicant, except where supplementation is required by the Pesticide Registration Review Committee.

If the applicant deems it necessary to submit additional information, they shall withdraw the original registration application. For a re‑application, the applicant shall submit the required documentation in accordance with the requirements applicable at the time of the re‑application.

NO.10 Chapter IV Review and Decision, with the addition of Article 25:

Provincial agricultural and rural affairs authorities shall conduct a preliminary review of the documents submitted by applicants, with particular focus on the following matters:

(1) Completeness. Based on the pesticide registration category or type, and in accordance with the requirements for registration documentation, verify whether the submitted materials are complete and comprehensive.

(2) Normativity. Verify whether the format of review documents, binding methods, and the preparation of test reports comply with relevant standards.

(3) Validity. The review shall verify whether the registered product complies with national pesticide industry policies, whether the trials have been filed and conducted in accordance with technical guidelines, and whether the test report has been issued by a qualified institution and remains within its validity period, among other criteria.

(4) Authenticity. This includes verifying whether the applicant meets the requirements, confirming that the test samples match the sealed samples, and ensuring that the tests were conducted in a genuine and compliant manner.

NO.11 Chapter IV Review and Decision: Article 20 of the original text has been renumbered as Article 26, with the following addition:

Provincial agricultural and rural affairs authorities shall, within ten working days, submit the preliminary review opinions and all application materials directly to the Ministry of Agriculture and Rural Affairs.

If the initial review is not approved and the applicant requests withdrawal, the application may be returned, and the applicant shall be notified in writing of the reasons.

NO.12 Chapter IV: Review and Decision—formerly Article 23, now revised to Articles 29 through 31:

Article 29: Based on the opinions of the Pesticide Registration Review Committee, the Ministry of Agriculture and Rural Affairs may request the applicant to submit supplementary materials. If the applicant submits such supplementary materials within the prescribed time limit, the Ministry shall re‑conduct the technical review and expert evaluation; the time required for the re‑review shall not be counted toward the overall technical review deadline.

Article 30: If an application for registration is not approved by the Ministry of Agriculture and Rural Affairs, the applicant may, within two years, submit a new application without re‑submitting the materials previously filed, provided that supplementary materials are submitted in accordance with the conclusions of the previous review; this exemption does not apply to matters involving human and animal safety, ecological and environmental safety, or the quality and safety of agricultural products. If the subsequent application is again rejected, or if a new application is filed, the applicant shall submit the complete set of required documents.

If the registration requirements or relevant standards change, or if the test report has expired, the complete registration dossier shall be resubmitted.

Article 31: If a pesticide product fails to obtain approval after three review attempts, and the applicant seeks to resubmit an application, the applicant shall conduct new pesticide registration trials.

NO.13 Chapter IV: Review and Decision—formerly Article 25, now revised as Article 33:

Within twenty working days from the date of receipt of the review opinions, the Ministry of Agriculture and Rural Affairs shall make an approval decision. If the application meets the requirements, a pesticide registration certificate shall be issued within ten working days; if it does not meet the requirements, the applicant shall be notified in writing with an explanation of the reasons. Where an application involves multiple matters, a registration certificate shall be issued for those that meet the requirements, and the applicant shall be notified in writing with an explanation of the reasons for those that do not meet the requirements.

NO.14 Chapter IV Review and Decision: Former Article 26 has been revised to Article 34, with the following additions:

The pesticide registration certificate shall specify the pesticide’s name, formulation, active ingredients and their concentrations, toxicity, scope of use, methods of application and dosage, the certificate holder, and the period of validity, among other particulars.

The format of the pesticide registration certificate number is: product category code + year + serial number. The product category code is PD, and the product category code for public health pesticides is WP. Both the year and the serial number are represented by four-digit numbers.

NO.15 Chapter V: Amendments and Renewals—formerly Article 28, now revised as Articles 36 and 37. Article 37 has been supplemented with the following:

Where the holder of a pesticide registration certificate changes its name, it shall submit the relevant supporting documents and apply to the Ministry of Agriculture and Rural Affairs for the reissuance of the pesticide registration certificate.

Where an enterprise holding a pesticide registration certificate is merged and subsequently deregistered, or where the holder of a new‑pesticide development project relinquishes its right to produce pesticides, the registration certificate may be transferred to the acquiring or transferring entity. Both the acquiring and transferring parties shall jointly submit an application to the Ministry of Agriculture and Rural Affairs, along with the relevant supporting documents, for the issuance of a new pesticide registration certificate.

NO.16 Chapter V: Amendments and Renewals—formerly Article 29, now renumbered as Article 38—has been amended to include:

Apply for renewal between 180 and 90 days prior to the expiration date (see the figure below for details).

NO.17 Chapter V: Amendments and Renewals, formerly Article 32, now revised as Article 41:

The Ministry of Agriculture and Rural Affairs reviews the application materials for registration renewal and makes a decision on whether to renew the registration prior to the expiration of the current validity period.

(1) Where the conditions are met, registration shall be renewed.

(2) Applications for registration renewal shall not be approved if the applicant does not hold a pesticide production license.

(3) If the scope of the production license does not match that of the pesticide registration certificate, the renewal of the registration shall be suspended; if the corresponding production license scope still cannot be obtained within five years, the registration renewal shall be denied.

(4) Upon review by the Pesticide Registration Review Committee, applications shall not be granted registration renewal if the product poses safety risks to agriculture, forestry, agricultural product quality, human and animal health, or the ecological environment, or if target organisms exhibit a marked increase in resistance or a severe decline in efficacy.

(5) For pesticide products subject to periodic evaluation, registration renewal shall be denied if the relevant evaluation reports fail to meet the required standards.

NO.18 Chapter VI: Risk Detection and Assessment, with the addition of Article 46:

Agricultural and rural administrative departments at or above the provincial level shall conduct risk assessments of monitoring results and issue early warning measures for pesticide varieties that pose high risks or demonstrate poor efficacy.

NO.19 Chapter VII: Supervision and Administration—formerly Articles 38 and 39, now renumbered as Article 48:

If an applicant or its agent (institution) conceals relevant information or submits false pesticide registration data and test samples, the Ministry of Agriculture and Rural Affairs shall record such violations in its integrity file and make them public.

No new registration applications from this applicant shall be accepted within one year.

For applications that have been approved for registration, the pesticide registration certificate shall be revoked, and no new registration applications from the same applicant shall be accepted for a period of three years. For those whose pesticide registration certificates have been revoked, no new registration applications from the same applicant shall be accepted for a period of five years.

Where a pesticide registration officer conceals relevant information, submits false pesticide registration data or test samples, or interferes with registration testing and review activities, thereby causing serious consequences, such officer shall be prohibited from engaging in any pesticide registration‑related work for a period of ten years.

Source: Agrochemical Compliance 24/7