Measures for the Administration of Pesticide Registration (Repromulgated after amendment pursuant to Ministry of Agriculture and Rural Affairs Order No. 1 of 2022)

Administrative Measures for Pesticide Registration

(Promulgated by Order No. 3 of the Ministry of Agriculture on June 21, 2017; amended by Order No. 2 of the Ministry of Agriculture and Rural Affairs on December 6, 2018, and by Order No. 1 of the Ministry of Agriculture and Rural Affairs on January 7, 2022)

Chapter I General Provisions

Article 1: In order to standardize pesticide registration procedures, strengthen the administration of pesticide registration, and ensure the safety and efficacy of pesticides, these Measures are hereby formulated in accordance with the Regulations on the Administration of Pesticides.

Article 2: Pesticides manufactured, marketed, or used within the territory of the People’s Republic of China shall obtain pesticide registration.

Pesticides that have not obtained a pesticide registration certificate in accordance with the law shall be treated as counterfeit pesticides.

Article 3 The Ministry of Agriculture and Rural Affairs is responsible for the nationwide management of pesticide registration, shall establish a Pesticide Registration Review Committee, and shall formulate the rules governing pesticide registration review.

The agency under the Ministry of Agriculture and Rural Affairs responsible for pesticide registration is tasked with the specific implementation of nationwide pesticide registration.

Article 4. The agricultural and rural affairs authority of the provincial people’s government (hereinafter referred to as the provincial agricultural and rural affairs department) is responsible for accepting pesticide registration applications within its administrative jurisdiction, reviewing the application materials, and submitting preliminary review opinions.

The provincial agricultural and rural affairs department’s agency responsible for pesticide registration testing (hereinafter referred to as the provincial pesticide registration testing agency) shall assist in carrying out the specific tasks related to pesticide registration.

Article 5: Pesticide registration shall adhere to the principles of science, fairness, impartiality, efficiency, and convenience for the public.

Article 6: Registration of safe, efficient, and cost-effective pesticides shall be encouraged and supported, and the phase-out of pesticides posing high risks to agriculture, forestry, human and animal health, the quality and safety of agricultural products, and the ecological environment shall be accelerated.

Chapter 2: Basic Requirements

Article 7: The name of a pesticide shall be the Chinese common name or the simplified Chinese common name of the pesticide. For plant‑origin pesticides, the name may consist of the plant name followed by “extract.” The name of a sanitary pesticide intended for direct use shall be expressed as a functional descriptor followed by the dosage form.

Article 8: The determination of the content of active ingredients and the formulation types of pesticides shall comply with the principles of improving quality, protecting the environment, and promoting sustainable agricultural development.

The formulation of a formulated product shall be scientifically sound, reasonably designed, and convenient for use. For single‑ingredient products with the same active ingredient and formulation type, the number of concentration levels shall not exceed three. Mixed‑formulation products shall contain no more than two active ingredients; for herbicides, seed treatments, pheromones, and similar products, the number of active ingredients shall not exceed three. For mixed‑formulation products with identical active ingredients and formulations, the number of mixing ratios shall not exceed three, and the total number of concentration levels corresponding to those ratios shall not exceed three. Pesticides with low active‑ingredient content that are used directly without dilution or dispersion shall be classified separately. Specific requirements in this regard shall be prescribed separately by the Ministry of Agriculture and Rural Affairs.

Article 9: The Ministry of Agriculture and Rural Affairs shall, in accordance with the toxicity and hazards of pesticide adjuvants, promptly publish and revise the lists of prohibited and restricted adjuvants, as well as their maximum allowable limits.

When the use of a product requires the addition of specified adjuvants, the corresponding test data shall be submitted at the time of pesticide registration.

Article 10: The dilution ratio or application concentration of a pesticide product shall be compatible with the corresponding application technology.

Article 11: The relevant data or information provided by the applicant shall be sufficient to meet the requirements of the risk assessment, and the product shall be comparable to, or demonstrably superior to, already registered products in terms of safety, efficacy, and other aspects.

When reviewing applications for product registration and referring to the risk assessment results of already registered products, the principle of maximum risk shall be applied.

Article 12: Applicants shall submit the relevant materials as prescribed and shall be responsible for the authenticity and legality of the information provided.

Chapter 3 Application and Acceptance

Article 13: The applicant shall be a pesticide manufacturing enterprise, an enterprise exporting pesticides to China, or a developer of a new pesticide.

A pesticide manufacturing enterprise refers to a domestic enterprise that has obtained a pesticide production license. An enterprise exporting pesticides to China (hereinafter referred to as a foreign enterprise) is one that exports pesticides manufactured abroad to China. A new‑pesticide developer refers to Chinese citizens, legal persons, or other organizations that research and develop new pesticides within the territory of China.

For a new pesticide jointly developed by multiple entities, one of the entities shall be designated as the applicant, and the other collaborating research institutions shall be identified, along with supporting documentation demonstrating the homogeneity of the relevant test samples. No other entity may submit a duplicate application.

Article 14: Domestic applicants shall submit applications for pesticide registration to the provincial agricultural and rural affairs department of their place of residence. Foreign enterprises shall submit applications for pesticide registration to the Ministry of Agriculture and Rural Affairs.

Article 15: Applicants shall submit the following application materials: test reports on product chemistry, toxicology, pharmacology, residue, and environmental impact; risk assessment reports; samples of labels or instruction manuals; product safety data sheets; relevant literature; the application form; proof of the applicant’s qualifications; and a declaration attesting to the authenticity of the submitted documents.

The application materials for pesticide registration shall be truthful, standardized, complete, and valid; specific requirements shall be separately formulated by the Ministry of Agriculture and Rural Affairs.

Article 16: Registration test reports shall be issued by registration testing institutions accredited by the Ministry of Agriculture and Rural Affairs, or by relevant overseas laboratories that have signed mutual recognition agreements with the competent authorities of the Chinese government; however, tests closely related to environmental conditions—such as efficacy, residue, and environmental impact—and registration tests involving biological species unique to China must be conducted within the territory of China.

Article 17: An application for the registration of a new pesticide shall be submitted concurrently with applications for the registration of both the technical grade material and the formulated product, and a reference standard of the pesticide shall be provided.

Within six years from the date of registration of a new pesticide, any other applicant who submits an application for registration based on data obtained by itself or authorized and consented to by the holder of the new pesticide registration certificate shall have such application treated as a new pesticide registration application.

Article 18: The complete registration dossier, independently owned by the holder of a pesticide registration certificate and meeting the requirements for registration data, may be licensed for use by other applicants.

In accordance with Article 14 of the Regulations on the Administration of Pesticides, where pesticide registration data is transferred, the transferee shall submit an application for pesticide registration, accompanied by the transfer contract between the parties and registration dossiers that meet the relevant requirements.

Article 19 The Ministry of Agriculture and Rural Affairs or the provincial agricultural and rural affairs department shall, in accordance with the following circumstances, make separate decisions regarding the application materials submitted by the applicant:

(1) For applications that do not require pesticide registration, the applicant shall be promptly notified that the application will not be accepted.

(2) If there are errors in the application materials, applicants shall be permitted to correct them on the spot.

(3) If the application materials are incomplete or do not conform to the legally prescribed format, the applicant shall be notified on the spot or within five working days of all the items that need to be supplemented in a single notice. If such notification is not provided within the specified time limit, the application shall be deemed accepted as of the date of receipt of the application materials.

(4) If the application materials are complete and conform to the statutory form, or if the applicant submits all supplementary materials as required, the application shall be accepted.

Chapter 4: Review and Decision

Article 20: Within twenty working days from the date of acceptance of the application, the provincial agricultural and rural affairs department shall conduct a preliminary review of the materials submitted by the applicant, issue its preliminary opinion, and submit it to the Ministry of Agriculture and Rural Affairs. If the preliminary review is not approved, the department may, in accordance with the applicant’s wishes, notify the applicant in writing and provide a statement of reasons.

Article 21: Upon receipt of an application or the application materials and preliminary review opinions submitted by the provincial agricultural and rural affairs authorities, the Ministry of Agriculture and Rural Affairs shall, within nine months, complete the technical review of the product’s chemistry, toxicology, efficacy, residues, environmental impact, and label samples, and submit its review opinions to the Pesticide Registration Review Committee for evaluation.

Article 22: Upon receipt of the technical review opinions, the Pesticide Registration Review Committee shall render its review opinion in accordance with the Rules for Pesticide Registration Review.

Article 23: After a pesticide registration application has been accepted, the applicant may withdraw the application and, upon supplementing and completing the relevant documentation, reapply.

The Ministry of Agriculture and Rural Affairs, in accordance with the opinions of the Pesticide Registration Review Committee, may require the applicant to submit additional information.

Article 24: During the registration review and evaluation period, the type of registration application submitted by the applicant, as well as the technical requirements and approval procedures it is based upon, shall not be altered by the fact that another applicant obtains a pesticide registration certificate during the same period.

Following the approval of a new pesticide, pending registration applications from other applicants may continue to be reviewed and evaluated in accordance with the established procedures for new‑pesticide registration. Alternatively, such applicants may withdraw their applications and resubmit new registration requests.

Article 25: 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; if it does not meet the requirements, the applicant shall be notified in writing with an explanation of the reasons.

Article 26: Pesticide registration certificates shall be uniformly printed by the Ministry of Agriculture and Rural Affairs.

Chapter 5: Amendments and Renewal

Article 27: The validity period of a pesticide registration certificate is five years.

Article 28: During the validity period of a pesticide registration certificate, if any of the following circumstances occur, the holder of the certificate shall apply to the Ministry of Agriculture and Rural Affairs for an amendment:

(1) Those that alter the scope of pesticide use, the method of application, or the dosage;

(2) Altering the compositional ingredients other than the active ingredient of a pesticide;

(3) Those that alter the product’s toxicity classification;

(4) Where the content of the active ingredient in the technical-grade product has changed;

(5) Where the product quality standards have changed;

(6) Other circumstances prescribed by the Ministry of Agriculture and Rural Affairs.

Where the holder of a pesticide registration certificate is changed, the relevant supporting documents shall be submitted to the Ministry of Agriculture and Rural Affairs for application to reissue the pesticide registration certificate.

Article 29: Where the validity period of a pesticide registration is about to expire and the registrant intends to continue manufacturing the pesticide or exporting it to China, an application for renewal shall be submitted no later than ninety days before the expiration date. If no renewal application is filed by the deadline, a new registration application shall be submitted.

Article 30: An application for amendment or renewal shall be submitted by the holder of the pesticide registration certificate to the Ministry of Agriculture and Rural Affairs, together with a completed application form and the relevant supporting documents.

Article 31 The Ministry of Agriculture and Rural Affairs shall complete the review of registration amendments within six months, formulate its review opinion, submit it to the Pesticide Registration Review Committee for evaluation, and render an approval decision within twenty working days from the date of receipt of the review opinion. If the application meets the requirements, the registration amendment shall be approved, with the registration certificate number and validity period remaining unchanged; if it does not meet the requirements, the applicant shall be notified in writing, together with a statement of reasons.

Article 32 The Ministry of Agriculture and Rural Affairs shall review the application materials for registration renewal and make a decision on whether to renew the registration prior to the expiration of the current validity period. If, during the review, potential hazards or risks to safety or efficacy are identified, the matter shall be submitted to the Pesticide Registration Review Committee for evaluation.

Chapter 6: Risk Monitoring and Assessment

Article 33: Agricultural and rural departments at or above the provincial level shall establish a pesticide safety risk monitoring system and organize pesticide registration testing institutions and plant protection agencies to monitor and evaluate the safety and efficacy of registered pesticides.

Article 34: Monitoring shall cover the impacts of pesticides on agriculture, forestry, human and animal health, the quality and safety of agricultural products, and the ecological environment.

An evaluation shall be organized and conducted in any of the following circumstances:

(1) Where multiple incidents of crop phytotoxicity have occurred;

(2) Where the target organism exhibits a substantial increase in resistance;

(3) Agricultural products with repeatedly exceeding maximum residue limits for pesticides;

(4) When multiple incidents of harm to non-target organisms—such as bees, birds, fish, silkworms, shrimp, and crabs—as well as to natural enemies have occurred;

(5) Those that have adverse impacts on groundwater, surface water, and soil;

(6) Those that pose health risks to pesticide users or to humans, livestock, and poultry.

Provincial agricultural and rural affairs departments shall promptly report the monitoring and evaluation results to the Ministry of Agriculture and Rural Affairs.

Article 35: The holder of a pesticide registration certificate shall collect and analyze information on changes in the safety and efficacy of the pesticide product, as well as on product recalls and incidents occurring during production and use.

Article 36: For pesticide varieties that have been registered for more than fifteen years, the Ministry of Agriculture and Rural Affairs shall, in light of changes in production, usage, and industrial policies, organize periodic evaluations.

Article 37: If it is found that a registered pesticide poses serious harm or significant risks to agriculture, forestry, human and animal health, the quality and safety of agricultural products, or the ecological environment, the Ministry of Agriculture and Rural Affairs shall convene the Pesticide Registration Review Committee to conduct a review. Based on the review results, the Ministry shall revoke or amend the corresponding pesticide registration certificate and, where necessary, prohibit its use or impose restrictions on its use, and shall publicly announce such measures.

Chapter 7: Supervision and Administration

Article 38: In any of the following circumstances, the Ministry of Agriculture and Rural Affairs or the provincial agricultural and rural affairs department shall not accept an application for pesticide registration; if the application has already been accepted, it shall not be approved:

(1) The authenticity, completeness, or compliance of the application materials does not meet the requirements;

(2) The applicant does not meet the eligibility requirements set forth in Article 13 of these Measures;

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

(4) The pesticide application for registration is among those that have been explicitly prohibited from production, marketing, or use by the relevant state authorities, or whose registration has been legally discontinued by the Ministry of Agriculture and Rural Affairs.

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

(6) Other circumstances in which the application should not be accepted or approved.

If an applicant conceals relevant information or submits false pesticide registration data and test samples, their application shall not be accepted for one year; if the registration has already been approved, the pesticide registration certificate shall be revoked, and the applicant shall be barred from submitting another application for three years. If a pesticide registration certificate has been revoked, the applicant shall be barred from submitting another application for five years.

Article 39: In cases where false documents or test samples are submitted, the Ministry of Agriculture and Rural Affairs shall record the applicant’s unlawful conduct in its integrity file and make such information public.

Article 40: Where any of the following circumstances exists, the Ministry of Agriculture and Rural Affairs shall revoke the pesticide registration certificate and make such revocation public:

(1) Where the validity period has expired and no renewal has been applied for;

(2) Where the holder of the pesticide registration certificate has been legally terminated or no longer meets the qualifications of a pesticide registration applicant;

(3) Where the pesticide registration data has been lawfully transferred;

(4) Other circumstances in which the pesticide registration certificate shall be revoked.

Article 41 The Ministry of Agriculture and Rural Affairs shall promote the development of a pesticide registration information platform, progressively implement online processing for registration applications and acceptance, and, through its website or by issuing pesticide registration announcements, publicly disclose information on the issuance, renewal, amendment, revocation, and cancellation of pesticide registration certificates, as well as relevant details such as pesticide product quality standard numbers, maximum residue limits, testing methods, and approved label contents.

Article 42: If any member of the Pesticide Registration Review Committee seeks improper benefits in the course of pesticide registration review, the Ministry of Agriculture and Rural Affairs shall remove such member from the committee; if the individual is a state functionary, the matter shall be referred to the relevant authorities for disciplinary action in accordance with the law; and if the conduct constitutes a crime, criminal liability shall be pursued in accordance with the law.

Article 43 The Ministry of Agriculture and Rural Affairs, provincial agricultural and rural affairs departments, and the personnel responsible for pesticide registration shall perform their duties in accordance with the law, provide review and evaluation opinions that are scientific, objective, and impartial, and maintain confidentiality regarding the registration materials submitted by applicants as well as any unpublished review and evaluation results and opinions. They shall recuse themselves when they have a conflict of interest with an applicant or with the applicant’s products (or related materials), and shall not engage in the production or marketing of pesticides.

Article 44: If pesticide registration personnel fail to perform their duties in accordance with the law, abuse their authority, engage in favoritism or corruption, solicit or accept property from others, or seek other improper benefits, they shall be subject to disciplinary sanctions in accordance with the law; furthermore, they shall be prohibited from engaging in pesticide registration work for a period of five years from the date the disciplinary decision is made.

Article 45 Any organization or individual who discovers circumstances in violation of the provisions of these Measures shall have the right to report such violations to the Ministry of Agriculture and Rural Affairs or the provincial agricultural and rural affairs authorities. The Ministry of Agriculture and Rural Affairs or the relevant provincial authorities shall promptly verify and address the reports, and shall maintain the confidentiality of the informants. Where the reported facts are substantiated and the reporting has played a positive role in ensuring production safety or has resulted in substantial loss mitigation, the informant shall be commended or rewarded in accordance with applicable national regulations.

Chapter VIII Supplementary Provisions

Article 46: Registration of pesticides intended for use on minor specialty crops shall be subject to group-based registration and management that expands the scope of authorized uses. The scope of such minor specialty crops shall be determined by the Ministry of Agriculture and Rural Affairs.

For specialty minor crops or emerging pests for which no registered pesticides are yet available, provincial agricultural and rural affairs authorities may, based on local conditions and provided that risks remain manageable, implement temporary phytosanitary measures and submit such measures for record‑keeping with the Ministry of Agriculture and Rural Affairs.

Article 47: The following terms used in these Measures shall have the meanings set forth below:

(1) A new pesticide refers to a pesticide whose active ingredient has not yet been approved for registration in China, including both new technical-grade pesticides (active ingredients) and new formulated pesticides.

(2) Technical material refers to the product obtained during the manufacturing process, consisting of the active ingredient and relevant impurities, with a small amount of additives optionally added when necessary.

(3) Active ingredient refers to a product obtained during the manufacturing process, composed of the active substance and relevant impurities, and may contain small amounts of necessary additives and appropriate diluents.

(4) Formulations refer to pesticide products that are processed from active ingredients (technical-grade materials) and suitable adjuvants, or that are produced through biological fermentation, plant extraction, or other methods, and which maintain a stable physical state.

(5) Adjuvants refer to any substance, other than the active ingredient, that is added to a pesticide product; such substances do not possess pesticidal activity or the functions of an active ingredient themselves, but are capable of, or help to, enhance and improve the physicochemical properties of the pesticide product, whether they consist of a single component or multiple components.

Article 48: The registration and management of pesticides intended for use exclusively outside China shall be governed by separate regulations issued by the Ministry of Agriculture and Rural Affairs.

Article 49 This Measures shall come into force on August 1, 2017.

Prior to June 1, 2017, temporary pesticide registration certificates that had already been issued will not be renewed upon expiration; pesticide registration applications that have been accepted but for which a review decision has not yet been made shall be processed in accordance with the relevant provisions of the Regulations on the Administration of Pesticides.

Source: Ministry of Agriculture and Rural Affairs Website