Far-reaching impact! Proposed Revision of the Measures for the Administration of Pesticide Registration Trials in China

On June 16, 2023, the Ministry of Agriculture and Rural Affairs in China published the draft version Measures for the Administration of Pesticide Registration Trials on its website. If companies in the industry have revision suggestions for the draft, they need to submit their revision opinions to the Pesticide Management Division of the Ministry of Agriculture and Rural Affairs before June 30.

CIRS Group has compared the current "Measures for the Administration of Pesticide Registration Trials" with the basic requirements of the draft, and summarized and commented on the main changes as follows.

Article 1: In order to strengthen the management of pesticide registration trials, ensure the integrity, reliability, and authenticity of pesticide registration trial data, and achieve full traceability of registration trials, these measures are developed in accordance with the "Pesticide Management Regulations."

CIRS Comments: The change in Article 1 specifies that the purpose of the Measures for the Administration of Pesticide Registration Trials is to strengthen the management of pesticide registration trials and achieve full traceability of registration trials. This change summarizes the direction of this revision, and we will now look at how to achieve traceability of registration trials.

Article 4: Institutions applying to undertake pesticide registration trials shall meet the following conditions and conduct trial operations for more than six months:

(1) Having independent legal personality or applying with the authorization and consent of the legal person and promising to undertake corresponding legal responsibilities;

(2) Having trial sites, environmental facilities, trial facilities and equipment, sample and file storage facilities that match the scope of the registration trial applied for;

(3) Having a sound organizational management system, key personnel in charge of the institution, quality assurance department, trial project, file management, and sample management, as well as corresponding trial and work staff;

(4) Key personnel shall establish legal employment or employment relationships with the trial lab; have relevant professional undergraduate or higher education and work experience, professional and management levels that are suitable for the scope of the registration trial applied for; at least one full-time key personnel for each key position, and key personnel shall not hold multiple positions simultaneously;

(5) Having corresponding standard operating procedures that meet the quality management requirements of pesticide registration trials;

(6) Having equipment and facilities that record the full traceability information of pesticide registration trials.

Article 5: Institutions applying to undertake pesticide registration trials shall submit the following materials to the Ministry of Agriculture and Rural Affairs:

(7) Materials proving the equipment and facilities that record the full traceability information of pesticide registration trials.

CIRS Comments: Articles 4 and 5 can be viewed together. The main changes are that institutions undertaking pesticide registration trials must have relevant professional undergraduate or higher education and work experience. In addition, it is stipulated that equipment and facilities that record the full traceability information of pesticide registration trials are required, which corresponds to the provisions in Article 1.

Article 13: When the certificate of the pesticide registration lab in China expires and it needs to continue to engage in pesticide registration trials, it shall reapply to the Ministry of Agriculture and Rural Affairs six months before the expiration; if it fails to reapply or the reapplication is not approved after the expiration, the pesticide registration trial report issued is invalid.

During the validity period of the certificate of the pesticide registration trial lab, if the pesticide registration trial lab no longer engages in pesticide registration trials or reduces the scope of the trials, it shall apply to the Ministry of Agriculture and Rural Affairs for the cancellation of the certificate of the pesticide registration trial lab or the scope of the trial.

The application materials for the certification of the pesticide registration trial lab shall be kept for no less than 10 years.

CIRS Comments: Article 13 adds that when the pesticide registration trial lab no longer engages in pesticide registration trials, it needs to apply for cancellation, and stipulates that the retention period for the application materials should be no less than 10 years.

Article 16: After being filed, the applicant for pesticide registration shall negotiate with the trial lab and promptly carry out the registration trial. If no relevant trial is initiated within one year, the filed information will automatically become invalid.

If there is a change in the pesticide registration trial lab, location, project, etc., the applicant for pesticide registration shall re-file.

CIRS Comments: This newly added section specifies the situation where the filed information becomes invalid if no relevant trial is initiated within one year of filing.

Article 18: Provincial-level pesticide testing institutions shall assign personnel to the production line or pilot production line of the pesticide registration applicant to collect and seal samples on-site as materials for conducting trials and spot checks, based on the needs of the pesticide registration applicant's proposed registration trials.

New pesticide developers and overseas enterprises may provide sealed samples themselves. When sealing the samples, the identity information of the sample provider should be verified for compliance. If the samples are sent by a third party, the pesticide registration applicant shall provide a letter of authorization, and experts may be appointed to conduct on-site verification if necessary.

CIRS Comments: This is the provision that has the greatest impact on domestic pesticide production enterprises in China. It is also an official measure to achieve traceability of registration trials. In the future, samples for registration trials will have to be collected on-site from the production line. This is also related to the requirement in the "Pesticide Registration Management Measures" that applicants must have a production license when applying for registration. If it is a new raw material project or a new formulation project in the factory, the samples for registration can be prepared together with the application for the corresponding production license. At the same time, an exemption is given for the samples provided by new pesticide developers and overseas enterprises.

Article 19: The provincial-level pesticide testing institutions shall retain one copy of the sealed trial sample, and the pesticide registration applicant and the registration trial lab shall each retain one copy, with a retention period of not less than two years. The sealed sample samples used for registration trials shall be sent directly by the pesticide registration applicant to the relevant registration trial lab for conducting registration trials. The sealed sample samples used for registration trials shall be consistent with the retained sealed sample samples.

Article 20: If the sealed sample samples are not sufficient to meet the needs of registration trials or if the sealed sample samples have exceeded the retention period but registration trials still need to be continued, resealing shall be carried out in accordance with the provisions of these Measures. If registration trials are conducted using sealed sample samples that have been sealed multiple times, the pesticide registration applicant shall be responsible for checking and verifying the consistency of the sealed sample samples from each time.

Article 21: The pesticide registration applicant shall provide the pesticide name, active ingredients and their contents, formulation, production date, specifications and quantity, storage conditions, quality guarantee period, product quality compliance test report, relevant spectra, and safety risk prevention measures to the registration trial lab for the sealed sample samples. The registration trial lab shall verify the integrity of the sealed sample, the information of the sealed sample, and the conformity of the test entrustor, and issue a receipt for the sample and related materials.

CIRS Comments: Articles 19 to 21 emphasize the traceability of samples and how to ensure the consistency of samples used for registration trials and those at the beginning of the trials. The management measures fully manage the pesticide registration applicant and the registration trial lab to ensure the traceability of samples.

Article 22: If a registration trial lab accepts the commission of a pesticide registration applicant to conduct registration trials, it shall sign an agreement with the applicant to clarify the rights and obligations of both parties, strictly abide by the requirements of the pesticide registration trial quality management standards, and reasonably charge the pesticide registration applicant for the commissioned trial fees. Agreements signed by other institutions or individuals with the trial lab cannot be used for registration of pesticide registration trials, and trial data cannot be used for pesticide registration.

CIRS Comments: This article adds a sentence: agreements signed by other institutions or individuals with the trial lab cannot be used for registration of pesticide registration trials, and trial data cannot be used for pesticide registration. This means that all pesticide registration trials in the future must be signed by the applicant and the trial lab to be used for pesticide registration. For overseas enterprise applicants, it would be better if they are allowed to have domestic agencies sign on their behalf.

Article 23: Pesticide registration trials shall be conducted in accordance with the statutory technical guidelines and methods for pesticide registration trials. Where there are no statutory technical guidelines and methods, the pesticide registration applicant and the trial lab shall negotiate and determine temporary trial methods, ensuring the scientific and accurate nature of the trial. If it is not possible to determine temporary trial methods, the agricultural and rural pesticide testing institution under the Ministry of Agriculture and Rural Affairs may be consulted to organize expert consultations.

CIRS Comments: A sentence has been added to specify how to conduct trials in the absence of technical guidelines and methods.

The above is only a personal opinion. If you in the industry have suggestions on this draft, please provide your opinions to the Ministry of Agriculture and Rural Affairs in a timely manner!

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

Pesticide registration in China