Measures for the Administration of Pesticide Registration Testing

(As amended by Order No. 3 of 2025 of the Ministry of Agriculture and Rural Affairs, on July 15, 2025)

(Originally promulgated as Order No. 6 of 2017 of the Ministry of Agriculture on June 21, 2017; revised by Order No. 2 of 2018 of the Ministry of Agriculture and Rural Affairs on December 6, 2018, by Order No. 1 of 2022 of the Ministry of Agriculture and Rural Affairs on January 7, 2022, and by Order No. 3 of 2025 of the Ministry of Agriculture and Rural Affairs on July 15, 2025)

Chapter I General Provisions

Article 1

These Measures are formulated in accordance with the Regulations on Pesticide Administration s to ensure the completeness, reliability and authenticity of data generated from pesticide registration studies, and to strengthen the administration of pesticide registration studies.

Article 2

An applicant for pesticide registration shall arrange for pesticide registration studies to be conducted in accordance with these Measures.

Before pesticide registration studies are conducted, the pesticide registration applicant shall file a record with the agricultural and rural authority of the people’s government of the province where the studies are conducted (hereinafter referred to as “provincial agricultural and rural authority”).

Article 3

The Ministry of Agriculture and Rural Affairs shall be responsible for the recognition of pesticide registration test facilities and the supervision and administration of registration tests; the specific work shall be undertaken by the institution responsible for pesticide control affiliated to the Ministry of Agriculture and Rural Affairs.

Provincial agricultural and rural authorities shall be responsible for the filing of pesticide registration tests and relevant supervision and administration within their respective administrative regions; the specific work shall be undertaken by the institution responsible for pesticide control affiliated to the provincial agricultural and rural authority (hereinafter referred to as “provincial pesticide verification institution”).

Article 4

Provincial agricultural and rural authorities shall strengthen  digital management of supervision and administration of pesticide registration tests, and upload information on the supervision and administration of registration tests to the pesticide administration information platform of the Ministry of Agriculture and Rural Affairs in a timely manner.

Chapter II Recognition of Test Facilities

Article 5

An institution applying to undertake pesticide registration studies shall meet the following conditions:

(1) Having independent legal person status, or being authorized by a legal person to apply and committing to bear corresponding legal liabilities;

(2) Having test sites, environmental conditions and facilities, test equipment, instruments, sample and archive storage facilities commensurate with the scope of registration tests applied for;

(3) Having professional technical and managerial personnel under lawful labor or employment relationships  who are commensurate with the scope of registration studies applied for;

(4) Having a sound organizational management system, with designated test facility management, a head of quality assurance unit, study directors, archivists, sample managers, and corresponding study and support personnel;

(5) Complying with the Good Laboratory Practice for Pesticide Registration Studies, and having formulated corresponding standard operating procedures;

(6) Having experience related to the scope of studies applied for, and having operated in compliance with the Good Laboratory Practice for Pesticide Registration Studies for not less than six months;

(7) Other conditions specified by the Ministry of Agriculture and Rural Affairs.

Article 6

An institution applying to undertake pesticide registration studies shall submit the following materials to the Ministry of Agriculture and Rural Affairs:

(1) Application form for recognition of a pesticide registration test facilities;

(2) Copy of legal person qualification certificate or power of attorney  from legal person;

(3) Organizational structure and responsibilities;

(4) List of quality management system documents (standard operating procedures) of the test institution;

(5) Certifying materials of test sites, test facilities, laboratories, etc., and list of instruments and equipment;

(6) List of professional technical and managerial personnel and relevant certifying materials;

(7) Statement on operation in compliance with the Good Laboratory Practice for Pesticide Registration Studies and copies of typical study reports and relevant original records.

Article 7

The Ministry of Agriculture and Rural Affairs shall review the materials submitted by the applicant. If the materials are incomplete or do not meet the statutory form, it shall inform the applicant of all contents to be supplemented or corrected on the spot or within five working days. If the application materials are complete and meet the statutory form, or the applicant submits all supplementary materials as required, the application shall be accepted.

Article 8

The Ministry of Agriculture and Rural Affairs shall conduct technical evalsuation of the application materials. The time required shall not be counted in the approval period and shall not exceed six months.

Article 9

Technical evalsuation includes document review and on-site inspection.

Document review mainly focuses on the applicant’s organizational structure, compatibility of test conditions and capabilities, integrity, authenticity and appropriateness of the quality management system and relevant materials.

On-site inspection mainly inspects the compliance of the applicant’s quality management system operation, test facilities and equipment conditions, test capabilities, etc.

Specific evalsuation rules shall be separately formulated by the Ministry of Agriculture and Rural Affairs.

Article 10

The Ministry of Agriculture and Rural Affairs shall make an  approval decision within 20 working days based on the evalsuation results. If the conditions are met, a Pesticide Registration Test Facilities Certificate shall be issued; if not, the applicant shall be notified in writing and the reasons stated.

Article 11

The Pesticide Registration Test facility Certificate is valid for five years, and shall specify the test facility’s name, unified social credit code, legal representative (person-in-charge), domicile, laboratory address, test scope, certificate number, validity period and other items.

Article 12

During the validity period of the Pesticide Registration Test Facility Certificate, if the test facility’s name, legal representative (person-in-charge) or domicile changes, it shall apply to the Ministry of Agriculture and Rural Affairs for certificate reissuance within 30 days from the date of the change and submit relevant certifying materials. The Ministry of Agriculture and Rural Affairs shall complete the review within 20 working days from the date of accepting the application, and replace the certificate if the conditions are met.

Article 13

During the validity period of the Pesticide Registration Test facility Certificate, the facility shall reapply to the Ministry of Agriculture and Rural Affairs under any of the following circumstances:

(1) Change of laboratory address or major change of facilities;

(2) Expansion of study scope;

(3) Other matters.

Article 14

To continue conducting pesticide registration studies upon expiration of the Pesticide Registration Test facility Certificate, the facility shall apply for renewal to the Ministry of Agriculture and Rural Affairs six months prior to expiration. An application submitted after the deadline shall be processed as a new application.

Specific requirements for renewal applications shall be separately prescribed by the Ministry of Agriculture and Rural Affairs.

Article 15

If the Pesticide Registration Test facility Certificate is lost or damaged, the entity shall explain the reasons, provide relevant certifying materials, and promptly apply to the Ministry of Agriculture and Rural Affairs for reissuance.

Chapter III Basic Requirements for Registration Studies

Article 16

Before pesticide registration studies are conducted, the pesticide registration applicant shall file a record with the provincial agricultural and rural authority where the registration study is conducted through the pesticide administration information platform of the Ministry of Agriculture and Rural Affairs in accordance with the procedures and requirements specified by the Ministry of Agriculture and Rural Affairs.

The filing information mentioned in the preceding paragraph includes the filing entity, active ingredient name, content and formulation, test items, test site, test facility, test start time, entrustment agreement signed with the test facility, safety precautions, etc. Filing for new pesticide tests shall also include the mechanism and mode of action.

If the test items, site, entity, etc. change, the pesticide registration applicant shall refile in accordance with the preceding paragraph.

Article 17

Pesticide registration test samples shall be mature and finalized products with product identification methods, quality control parameters and test methods.

The pesticide registration applicant shall be responsible for the authenticity and consistency of test samples.

Article 18

The pesticide registration applicant shall submit the test samples to the local provincial pesticide verification institution for sealing, provide information such as pesticide name, active ingredient(s) and content, formulation, sample production date, specification and quantity, storage conditions, shelf life, etc., and attach a product quality conformity test report and relevant spectra.

Article 19

One set of the sealed test samples shall be retained respectively by the provincial pesticide control institution and the pesticide registration applicant for a period of not less than two years, and the remaining samples shall be sent by the applicant to the registration test facility for testing.

Article 20

If the sealed test samples are insufficient for testing or have expired, and testing is still required, the pesticide registration applicant shall reseal the samples in accordance with these Measures.

Article 21

The pesticide registration applicant shall provide the pesticide registration test facility with information such as the pesticide name, content, formulation type, production date, storage conditions, and shelf life of the test samples, and safety risk prevention measures.

The pesticide registration test facility shall inspect the integrity of sealed samples and the conformity of sample information.

Article 22

Where a pesticide registration test facility is entrusted by a pesticide registration applicant to conduct registration studies, the two parties shall sign an agreement to clarify their rights and obligations.

Article 23

Pesticide registration studies shall be conducted in accordance with statutory technical guidelines and methods for pesticide registration studies. If no statutory technical guidelines and methods are available, they shall be determined through consultation between the applicant and the test facility, provided that the scientificity and accuracy of the tests are guaranteed.

If a major safety risk occurs during a pesticide registration studies, the test facility shall immediately stop the test, take corresponding measures to prevent further expansion of the risk, report to the local provincial agricultural and rural authority where the study is conducted, and notify the pesticide registration applicant.

Article 24

Upon completion of the test, the pesticide registration test facility shall issue a standardized study report to the pesticide registration applicant as agreed in the agreement.

Article 25

A pesticide registration test facility shall establish a full-process test recording system, and retain study plans, original records, specimens, retained test samples and reference substances, study reports, written materials and electronic data related to the study for at least seven years after the completion of the study, and may hand them over to the pesticide registration applicant for retention upon expiration. The pesticide registration applicant shall retain them for at least five years after the pesticide is withdrawn from the market.

The retention period of easily degradable specimens, retained test and control substances that are prone to quality changes shall be the period valid for evalsuation.

A test facility shall permanently retain records of facility operation and quality management, including organizational structure, personnel, quality assurance department inspection records, master schedules, and standard operating procedures, and upload relevant information on conducted registration studies to the pesticide administration information platform of the Ministry of Agriculture and Rural Affairs in a timely manner.

Chapter IV Supervision and Inspection

Article 26

Provincial agricultural and rural authorities and the Ministry of Agriculture and Rural Affairs shall supervise and inspect pesticide registration test facilities and registration test processes, focusing on the following contents:

(1) Changes in qualification conditions of test entities;

(2) Conditions of important test equipment and facilities;

(3) Consistency between filing information such as test sites and test items and actual practice;

(4) Compliance of test processes with statutory technical guidelines and methods;

(5) Implementation of safety risks prevention measures for registration studies ;

(6) Other circumstances that do not non-compliant with the Good Laboratory Practice for Pesticide Registration Studies or that affect registration study quality.

Provincial agricultural and rural authorities shall organize inspections of pesticide registration test facilities under their jurisdiction at a ratio of not less than 20% annually. The Ministry of Agriculture and Rural Affairs shall organize unannounced inspections from time to time based on registration evalsuations, complaints and reports.

Article 27

If uncontrollable safety risks are found during supervision and inspection, the study shall be ordered to suspend or terminate immediately, and the provincial agricultural and rural authority shall promptly report to the Ministry of Agriculture and Rural Affairs.

If it is found during supervision and inspection that a test facility no longer meets the specified conditions, the following measures shall be taken respectively:

(1) Where correction is possible, order improvement or correction within a time limit; if refusing to correct within the time limit or still failing to meet the specified conditions after correction, the Ministry of Agriculture and Rural Affairs shall revoke its test facility certificate;

(2) If Where correction is not possible, the Ministry of Agriculture and Rural Affairs shall revoke its test facility certificate.

Article 28

If a pesticide registration test facility commits any of the following acts, resulting in incorrect or unreviewable data or results, the agricultural and rural authority at or above the provincial level shall order correction within a time limit, give a warning, and may impose a fine of not less than 10,000 yuan but not more than 50,000 yuan:

(1) Sample receipt, identification, distribution, transfer, storage or disposal not in compliance with the Good Laboratory Practice for Pesticide Registration Studies, resulting in sample contamination, mix-up, damage, abnormal changes in properties, etc.;

(2) Use of uncertified, uncalibrated or unvalidated instruments, equipment or facilities;

(3) Failure to conduct tests in accordance with relevant technical guidelines and methods for pesticide registration studies;

(4) Failure to transmit or retain original data and reports in accordance with the Good Laboratory Practice for Pesticide Registration Studies;

(5) Other acts non-compliant with the Good Laboratory Practice for Pesticide Registration Studies.

Article 29

Any of the following acts by a pesticide registration test facility shall constitute issuance of false registration study reports and shall be penalized in accordance with Article 51 of the Regulations on Pesticide Administration:

1) Issuing study reports without conducting the study;

(2) Forging or altering original data or records, or using original data or records that were not generated in accordance with statutory technical guidelines and methods;

(3) Reducing, omitting or changing mandatory study items or changing key study conditions;

(4) Replacing sealed samples or changing their original state for testing;

(5) Forging the official seal of the test facility, the signature of the study report signatory or the issuance date;

(6) Other acts of issuing false registration study reports.

Article 30

A pesticide registration test facility shall submit an annual report on the implementation of the Good Laboratory Practice for Pesticide Registration Studies to the Ministry of Agriculture and Rural Affairs.

Article 31

Agricultural and rural authorities at or above the provincial level shall organize supervision and inspection on the conformity and consistency of pesticide test samples sealed for registration tests, and promptly report problems found during supervision and inspection to the Ministry of Agriculture and Rural Affairs.

Chapter V Supplementary Provisions

Article 32

Test items that cannot be undertaken by existing pesticide registration test facilities shall be undertaken by entities designated by the Ministry of Agriculture and Rural Affairs.

Article 33

These Measures shall come into force on August 1, 2017.

Pesticide registration test facilities publicly announced by the Ministry of Agriculture before the implementation of these Measures may continue to conduct pesticide registration studies within their validity periods. Those intending to continue conducting registration study upon expiration shall apply for recognition as test facilities in accordance with these Measures.

Note: This English translation is provided for reference only and does not constitute an official translation. In case of any discrepancy, the Chinese text shall prevail.