Major Changes and Impacts of Five Regulations Including the "Regulations on Pesticide Registration Management"

From April 2022, when the Pesticide Management Department of the Ministry of Agriculture and Rural Affairs first solicited opinions and suggestions on the revision of five regulations, including the "Pesticide Registration Management Measures ", "Pesticide Production License Management Measures", "Pesticide Business License Management Measures", "Pesticide Label and Instructions Management Measures", and "Pesticide Registration and Testing Management Measures"; to the beginning of 2023, when the Pesticide Management Department of the Ministry of Agriculture and Rural Affairs issued the second letter soliciting opinions on the draft revision of five regulations including the "Pesticide Registration Management Measures"; to November 4, 2024, the Ministry of Agriculture and Rural Affairs issued the third notice on soliciting public opinions on the "Decision of the Ministry of Agriculture and Rural Affairs on Amending Five Regulations including the "Pesticide Registration Management Measures" (Draft for Soliciting Opinions)". This article mainly introduces the main changes in the five management measures and their impacts .

I. Pesticide Registration Management Measures

The second paragraph of Article 8 is amended as follows: "There are no more than three active ingredients in herbicides, seed treatment agents, pheromones, etc." to "There are no more than three active ingredients in herbicides and seed treatment agents. Pheromones and other attractants and disorienting products shall be registered based on the main active ingredients."

Comments: It reasonably stipulates the registration requirements for attractants and disorienting products such as pheromones. Registration is based on the main active ingredients, and there is no limit on the number of active ingredients. In other words, it is not necessary to meet the gradient management regulations for pesticide active ingredients.

Article 18 The holder of a pesticide registration certificate may authorize other applicants to use the complete registration information that meets the registration information requirements independently in accordance with the provisions of the second paragraph of Article 10 of the Pesticide Management Regulations.

According to the relevant content of Article 10, paragraph 2 of the Pesticide Management Regulations:

Pesticides with the same composition, scope of use and method of use as those that have obtained China pesticide registration are exempt from residue and environmental testing. However, pesticides that have obtained China pesticide registration are within the registration information protection period in accordance with Article 15 of these Regulations and must be authorized and agreed by the pesticide registration certificate holder.

Comment: It is clarified that the registration information independently owned by the pesticide registration certificate holder only requires the authorization and consent of the registration certificate holder during the protection period of the registration information.

The phrase “and submit to the Ministry of Agriculture and Rural Affairs” in Article 20 shall be amended to “and the preliminary review opinions and all application materials shall be directly submitted to the Ministry of Agriculture and Rural Affairs within five working days”.

Article 21 After accepting an application or receiving the application materials and preliminary review opinions submitted by the provincial agricultural and rural departments, the Ministry of Agriculture and Rural Affairs shall organize its affiliated pesticide testing institutions to complete the technical review work.

Comment: It clarifies the responsibilities of provincial pesticide testing agencies and emphasizes the importance of the preliminary review opinions of provincial pesticide testing agencies.

Article 21: If the pesticide testing agency of the Ministry of Agriculture and Rural Affairs finds that the application materials have minor flaws that need to be corrected during the technical review process, it may require the applicant to provide additional relevant materials.

Article 23 The Ministry of Agriculture and Rural Affairs may require the applicant to provide additional information within a specified time based on the opinions of the Pesticide Registration Review Committee.

One more article is added after Article 23: "If it is found during the pesticide registration review and evaluation process that the test report submitted by the applicant is controversial and needs to be verified, the Ministry of Agriculture and Rural Affairs may organize a verification test and inform the applicant of the required time.

Comments: The time limit and conditions for supplementary information are clarified. It would be better if corrections can be allowed like product registrations of other ministries . It would be more perfect if the definition of minor defects can be explained.

Article 29 If the holder of a pesticide registration certificate changes its name or an enterprise merges or splits up and needs to change the holder of a pesticide registration certificate, it shall apply to the Ministry of Agriculture and Rural Affairs for a replacement certificate within 30 days from the date of the change and submit relevant supporting materials. The Ministry of Agriculture and Rural Affairs shall complete the review and reissue the certificate within 20 working days from the date of acceptance of the application.

Comment: The previous " change of pesticide registration certificate holder " has been changed to " pesticide registration certificate holder changes its name, and the pesticide registration certificate holder needs to be changed due to enterprise merger and separation " . It may not be easy to change the registration certificate holder at will in the future.

second paragraph of Article 37 adds: The periodic evaluation focuses on the evaluation of target resistance, crop safety, agricultural product quality safety, beneficial biological safety, user health safety and ecological environmental impact. The evaluation report results serve as an important basis for the registration renewal review.

Comment: China is also about to join the ranks of periodic evaluation of pesticides, which is similar to the EU's re-evaluation. Companies should pay attention to periodic evaluation of pesticides.

II. Measures for the Administration of Pesticide Production License

Article 20 Pesticide manufacturers may, within the scope of their pesticide production licenses, process or repackage pesticides on behalf of new pesticide developers and other pesticide manufacturers in accordance with the provisions of Article 19 of the Pesticide Management Regulations; they may also repackage pesticides on behalf of companies that export pesticides to China.

If a pesticide manufacturer entrusts others to produce its registered products, it must hold a pesticide production license for the corresponding production scope.

The production of technical (concentrated) drugs shall not be outsourced.

Article 21 The principal and the agent shall sign a consignment contract to specify the name, specifications and quantity, quality standards, labels and trademarks, term and fees of the products entrusted for processing and repackaging.

Article 22 It is prohibited to rent or lend pesticide registration certificates in the name of commissioned processing or repackaging.

Comments: It is clear that the original drug (mother drug) cannot be entrusted for production , and it also stipulates that the principal and the trustee need to sign a contract and other details.

III. "Measures for the Administration of Pesticide Business Licenses"

Added to Article 20 is “no illegal bundled sales of pesticides”.

Comment: It is clearly stipulated that pesticides cannot be sold in bundles.

Article 21 adds “a pesticide business license shall be obtained and the website name, network platform name, application name, etc. shall be reported to the licensing authority for record”

Article 22 Those who use the Internet to sell pesticides shall continue to publicize pesticide business license information in a prominent position on the homepage of their website or the main page of their business activities. If the pesticide business license information changes, the page content should be updated within ten working days. Those who use the Internet to sell pesticides must display relevant information about pesticide products that are true, accurate, and legal.

Article 23 Third-party platforms for online pesticide transactions shall establish and implement management systems such as pesticide business qualification verification, business behavior supervision, pesticide information display, real-name pesticide purchase, pesticide product distribution, transaction record preservation, and complaint and report handling.

Comment: With the rise of online shopping, laws and regulations have also changed with the times, improving and standardizing the obligations and responsibilities of online pesticide dealers.

Article 28 If a pesticide dealer illegally bundles and sells pesticides, or uses the Internet to sell pesticides without truthfully publicizing or displaying the pesticide business license and related information of pesticide products, the agricultural and rural administrative department at or above the county level shall order it to correct the violation; if it refuses to correct the violation or the circumstances are serious, a fine of not less than RMB 1,000 and not more than RMB 10,000 shall be imposed.

Comment: It stipulates relevant punishment measures for bundled sales of pesticides and illegal online pesticide operations. Pesticide dealers must operate in compliance with the regulations.

IV. Measures for the Administration of Pesticide Labels and Instructions

Article 9 Preparation products shall be labeled with the registration number of the original drug and the name of the manufacturer ; if registered for use in herbicide-resistant genetically modified crops, the names of the applicable genetically modified crops and transformants shall be labeled; if used in herbicide-resistant non-genetically modified crops, the names of the applicable crop varieties shall be labeled; if designated adjuvants need to be added during use, the relevant information shall be labeled.

Comment: The labeling content of herbicide-resistant genetically modified crops is more detailed, and the formulation products are required to be marked with the registration number of the original drug and the name of the manufacturer. Companies should pay attention to this, as the operation is also relatively difficult.

Article 31, paragraph 1 Pesticide labels and instructions may not use unregistered trademarks, and the same pesticide product label from the same registration certificate holder can only be marked with the same trademark.

Comment: One certificate for one product is here, which stipulates that the trademark must be registered and the number can only be one.

V. Measures for the Administration of Pesticide Registration and Testing

Article 17 Before conducting pesticide registration tests, pesticide registration applicants shall file with the provincial agricultural and rural departments where the registration test is located through the pesticide management information platform of the Ministry of Agriculture and Rural Affairs in accordance with the procedures and requirements prescribed by the Ministry of Agriculture and Rural Affairs. The filing information includes the filing subject, the name, content and dosage form of the active ingredient, the test project, the test site, the test unit, the start time of the test, the entrustment agreement signed with the test unit, safety precautions, etc. The filing of new pesticide tests should also add the mechanism and mode of action. If there are changes in the test unit, location, project, etc., the pesticide registration applicant shall re-file in a timely manner.

Comments: The trial registration platform has been changed from the China Pesticide Digital Supervision and Management Platform to the Ministry of Agriculture and Rural Affairs Pesticide Management Information Platform. If there are any changes in the trial unit, location, or project, re-registration is required.

The revision of five regulations, including the "Pesticide Registration Management Measures", which took almost two years, has concerned the agricultural industry. Let us wait and see the final released version.

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