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In accordance with the Regulations on the Administration of Pesticides, the Decision of the State Council on Cancelling and Delegating a Batch of Administrative Licensing Items (Guofa [2020] No. 13), the Measures for the Administration of Pesticide Registration, and the Measures for the Administration of Pesticide Registration Trials, and in order to standardize the filing and management of pesticide registration trials, streamline services, and better serve enterprises, our Ministry has formulated the “Regulations on the Filing and Management of Pesticide Registration Trials” (Draft for Public Comment). We are now soliciting public comments; please submit your feedback to the Pesticide Management Division of our Department by October 10, 2020.
Attachment: Regulations on the Filing and Administration of Pesticide Registration Trials (Draft for Comments)
Pesticide Management Division, Ministry of Agriculture and Rural Affairs
Regulations on the Filing and Management of Pesticide Registration Trials
(Draft for Public Comment)
In accordance with the Regulations on the Administration of Pesticides, the Decision of the State Council on Cancelling and Delegating a Batch of Administrative Licensing Items (Guofa [2020] No. 13), the Measures for the Administration of Pesticide Registration, and the Measures for the Administration of Pesticide Registration Trials, and in order to standardize the filing and management of pesticide registration trials, streamline services, and better serve both the public and enterprises, the relevant matters are hereby announced as follows.
1. For conducting pesticide registration trials, the registrant—whether a developer of a new pesticide, a pesticide manufacturer, or an enterprise exporting pesticides to China—shall file a record with the provincial agricultural and rural affairs authority where the trial is conducted. For joint trials on minor specialty crops commissioned by agricultural and rural affairs authorities at or above the provincial level or by pesticide testing institutions, the lead pesticide registration trial entity shall submit a unified record to the provincial agricultural and rural affairs authority in the trial location. Failure to file as required will result in the rejection of pesticide registration applications; applications already accepted will not be approved.
II. Registration testing for pesticides shall be filed on the “China Pesticide Digital Supervision and Management Platform” (http://www.chinapesticide.org.cn) prior to the commencement of the trial.
3. The registration information shall include the registrant, the name of the active ingredient, its concentration and formulation, the test items, the test location, the testing institution, the year in which testing commenced, and safety precautions, among other details. For new pesticide trials, the mechanism of action and mode of action must also be specified.
4. For the same product, the filer shall use a single registration number. All test items may be registered in one submission, or registered in multiple installments. If information such as the testing institution or the testing period is amended, the registration number remains unchanged. In the event of withdrawal of the registration, the registration number shall be invalidated.
The filing number consists of the administrative division code of the province (autonomous region or municipality) where the filer is located, the date of the initial filing, the filing type code, and a sequential number.
5. 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).
If the content of the active ingredient in a pesticide product does not comply with the prescribed standards, it may be amended in accordance with the principle of similarity by referencing already registered products, and relevant tests shall be re‑filed based on the revised active ingredient content. When applying for pesticide product registration, the required documentation shall be submitted in compliance with the “Requirements for Pesticide Registration Data.”
If the active‑ingredient formulation of a pesticide product does not comply with the prescribed requirements, it may be amended in accordance with the principle of similarity to an already registered product, and relevant tests shall be re‑filed based on the revised formulation. When applying for pesticide product registration, in addition to submitting the pre‑amendment test data, the following post‑amendment documentation must also be provided:
(1) Where the formulation ratio has been changed but the intended uses remain identical to those of the registered product, submit the following: a description of the change; chemical data for the product (including the pre‑change reports on room‑temperature storage stability and method validation); and label samples. Also provide information on the recommended application rate, application techniques, maximum number of applications, safety interval, and any supporting documentation. If the active ingredient content has been increased, submit post‑change acute oral, dermal, and inhalation toxicity test reports as well.
(2) Where, following a change in the formulation ratio, the intended use differs from that of the registered product: submit an explanatory note on the change; product chemistry data (including the stability‑under‑ambient‑temperature storage test report and the analytical‑method validation report, which may use pre‑change data); efficacy trial reports from one year and multiple locations (four locations for insecticides and fungicides, five locations for herbicides and plant growth regulators); and label samples. Also provide information on the recommended application rate, application method, maximum number of applications, pre‑harvest interval, and any supporting documentation. For formulations with increased active‑ingredient content, submit post‑change acute oral, dermal, and inhalation toxicity study reports. If the revised formulation ratio falls outside the applicant’s in‑house formulation‑screening recommendations, an in‑house bioassay report for the new ratio must also be provided to verify its combined toxicological profile. Furthermore, if the post‑change application rate or frequency of the active ingredient is increased, or if the pre‑harvest interval is shortened, residue‑study data based on half the usual number of sampling points shall be submitted.
6. For agricultural formulated products with the same active ingredients and formulation types, in principle, the ratio of active ingredient contents between different formulations shall not be less than 1.
7. Trials that cannot be conducted by existing pesticide registration testing institutions shall be undertaken by institutions designated by the Ministry of Agriculture and Rural Affairs and shall be filed in accordance with relevant regulations.
8. The registrant shall ensure that the risks associated with pesticide registration trials are under control.
When a significant safety risk arises during pesticide registration trials, the trial sponsor shall immediately suspend the trial, implement appropriate measures to prevent the risk from escalating, and report the incident 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.
9. This announcement shall take effect from the date of its issuance. For trials that have already been completed but for which registration applications have not yet been submitted, or for pesticide registration trials currently underway that have not been filed, supplementary filing must be completed within six months. Failure to file by the deadline will result in the rejection of any subsequent pesticide registration application; applications already accepted will not be approved.
New Regulation No. 2:
Promote the implementation of green-channel management measures for pesticide registration and approval.
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To the Departments (Bureaus, Commissions) of Agriculture and Rural Affairs (Agriculture and Animal Husbandry) of all provinces, autonomous regions, and municipalities directly under the central government, and to the Bureau of Agriculture and Rural Affairs of the Xinjiang Production and Construction Corps:
In order to implement the spirit of the State Council’s “delegation, regulation, and service” reform, and in accordance with the Regulations on the Administration of Pesticides and the Measures for the Administration of Pesticide Registration, our company has decided to advance the implementation of green‑channel management measures for pesticide registration and approval, while ensuring the efficient and safe performance of products. Accelerate the registration and approval process for biopesticides, alternatives to highly toxic pesticides, and crop‑specific formulations for minor crops, thereby promoting high‑quality and environmentally friendly pesticide development.
(1) Microbial pesticides, plant-derived pesticides, biochemical pesticides, and agricultural antibiotics produced through biological fermentation;
(2) Products that have undergone joint registration trials for minor-use crops, organized by pesticide management or pesticide inspection agencies under provincial-level or higher agricultural and rural departments, and submitted through centralized application.
(3) New pesticides that replace highly toxic ones;
(4) Other products recognized by the Ministry of Agriculture and Rural Affairs.
(1) When applying for pesticide product registration, the applicant shall submit a written request for expedited registration review. For joint trials involving minor‑use crops, the written request for accelerated registration shall be submitted by the provincial agricultural and rural affairs department’s pesticide management authority or its pesticide inspection agency.
(2) When conducting the preliminary review of pesticide registration, provincial agricultural and rural affairs authorities shall provide an opinion on whether the products for which enterprises have applied under the green channel meet the relevant criteria.
(3) The Pesticide Inspection Institute of the Ministry of Agriculture and Rural Affairs shall review applications for expedited registration and approval. Products that meet the criteria for “green‑channel” status shall be submitted to the Office of the National Pesticide Registration Review Committee for approval.
(1) Prioritize technical review. For products that meet the requirements for the “Green Channel,” prioritize technical review and expedite the review process, while ensuring quality and safety.
(2) Implement a centralized review process for the registration of pesticides used on specialty minor crops. For such registrations, adopt a list‑based approach, conduct joint trials, and manage expanded‑use registrations in grouped batches; streamline procedures through centralized acceptance, review, and approval to expedite the authorization process.
(3) Strengthen guidance and services. Publicize and explain the green‑channel policy for pesticide registration, enhance technical training and advisory support, and guide pesticide companies in developing and registering highly effective, low‑toxicity, low‑risk products, thereby promoting the green and high‑quality development of the pesticide industry.
Pesticide Management Division, Ministry of Agriculture and Rural Affairs
Source: Ministry of Agriculture and Rural Affairs |
