Breaking News! China's ICAMA Published Revision to Pesticide Registration Measures

China's Institute Control of Agrochemicals, Ministry of Agricultural and Rural Affairs (ICAMA) published draft Provisions on the "Measures on the Management of Pesticide Registration" for public comments on May 12, 2023. Comments can be made to the Department of Pesticide Management, Ministry of Agriculture and Rural Affairs before May 30, 2023. We have compared the current version of "Measures on the Management of Pesticide Registration" with the draft and summarized the main changes for your reference.

Article 7: Applicants for registration of technical material (technical concentrate) must obtain the corresponding pesticide production license (except for new pesticides). When applying for registration of pesticide formulations, the technical material (technical concentrate) used should have obtained pesticide registration and be legally produced.

Comment: It is clearly stipulated that those who apply for the registration of technical material (technical concentrate) should obtain the corresponding pesticide production license. The technical material (technical concentrate) used for applying for pesticide formulation registration needs to be a legally produced pesticide, which requires a corresponding pesticide production license.

Article 9: Insect pheromones and other trapping and targeting products can be registered according to the actual active ingredients. The specific requirements will be formulated separately by the Ministry of Agriculture and Rural Affairs.

Comment: The principle of insect pheromone determines that the product characteristics are difficult to meet the gradient management regulations for active ingredients of pesticides, therefore, this new regulation is very reasonable.

Article 16: The registration officer shall be a staff member of the applicant. If the applicant truly needs to entrust others to handle the matter, a power of attorney shall be issued, specifying the specific entrusted matters. Agents (institutions) must not engage in or interfere with pesticide registration testing work, and shall not participate in or hold shares in pesticide registration testing units.

Comment: This new regulation strengthened the management of pesticide registration agents, and those who entrust others to register on their behalf need to submit a formal power of attorney. At the same time, it is required that agents do not participate in or control pesticide registration testing units to ensure the fairness of data issued by pesticide registration testing units as third-party testing institutions.

Article 18: For new pesticides that urgently need to be registered for the prevention and control of pests and diseases, the Ministry of Agriculture and Rural Affairs may accept test reports issued by relevant overseas laboratories, which comply with the relevant requirements on pesticide registration management, after expert evaluations.

Comment: The new regulations have opened up a gap in the testing reports issued by accredited overseas laboratories. But what is the definition of new pesticides that urgently need to be registered for disease and pest control? Will a corresponding list of pests and diseases that urgently need new pesticides be issued at the same time? Implementing relevant standards will make it more reasonable and convincing.

Article 20: When applying for the registration of the same technical material, same formulation, or similar formulation, the controlled product must have obtained pesticide registration when the pesticide registration tests are being filed.

Article 21: The holder of a pesticide registration certificate may authorize other applicants to use complete registration materials that meet the registration requirements and are independently owned by the holder. If the same pesticide variety has completed more than three cumulative tests in different testing institutions, its chronic toxicology and metabolite toxicology test data can be authorized separately. The cumulative authorization fee for the same data owner must not exceed 70% of the total authorized data testing fee. If the toxicological tests of the same metabolite have been completed more than three times in different testing institutions, enterprises can apply for exemption with the approval of the Pesticide Registration Review Committee.

Comment: What is the intention of the authority? Is it protection for the first enterprise to apply for new product registration? If the protection period for different materials submitted by enterprises can be clearly defined, it may be more conducive to protecting the innovation of enterprises.

Article 23: The Ministry of Agriculture and Rural Affairs or provincial agricultural and rural departments shall conduct a formal examination of the application materials submitted by the applicant, and accept those that meet the conditions. Any of the following situations will not be accepted:

(5) The applicant is included in the list of seriously dishonest units prescribed by the relevant state department and restricted from obtaining an administrative license;

(6) The registration test does not comply with the provisions of Articles 9 and 10 of the  Regulation on Pesticide Administration

(7) Repeated application.

Comment: This is a test for the personnel in the acceptance hall of the Ministry of Agriculture and Rural Affairs!

Article 24: The application materials for pesticide registration must be submitted at one time in accordance with the requirements of pesticide registration materials. After the registration application is accepted, no new materials can be added. Except for those required to be supplemented by the Pesticide Registration Review Committee.

If the applicant deems it necessary to supplement new information, they must withdraw the original registration application. If a new application is made, the application materials should be submitted according to the requirements at the time of the new application.

Article 29: The Ministry of Agriculture and Rural Affairs may, based on the opinions of the Pesticide Registration Review Committee, request the applicant to provide additional information.

If the applicant submits supplementary materials within the specified time, the Ministry of Agriculture and Rural Affairs will reorganize the technical review and expert review, and the time required for the new technical review will not be included in the technical review deadline.

Comment: Articles 24 and 29 can be read together. These are very close to the pesticide registration review in developed countries. It would be better if the specific time can be clearly defined, such as the time for those retests that are required, and the time for those that only explanations need to be supplemented.

Article 25: The provincial agricultural and rural departments must conduct a preliminary examination of the materials submitted by applicants, mainly examining the following matters:

1. Completeness – According to the registration items or types of pesticides, review whether the registration materials are complete according to the requirements of the registration materials;
2. Standard – Whether the format, binding method, and writing of test reports are standardized;
3. Effectiveness – Review whether the registered products comply with national pesticide industry policies, whether the tests are filed, whether they are carried out in accordance with technical guidelines, whether the reports are issued by qualified units, and whether they are within the validity period; and
4. Authenticity – Review whether the applicant meets the requirements, whether the test sample is consistent with the sealed sample, and whether the test is truly conducted.

Comment: This article stipulated specific review matters for provincial agricultural and rural departments.

Article 30: If the approval of the Ministry of Agriculture and Rural Affairs has not been approved, the applicant may not resubmit the previous application materials within two years, and submit supplementary materials according to the completion opinions, except for those involving human and animal safety, ecological environment safety, and agricultural product quality safety. If the reapplication is not approved, complete documents can be submitted for reapplication.

If there are changes in registration regulations and relevant standards or if the test report exceeds its validity period, complete registration materials should be resubmitted.

Comment: This is a reasonable policy worth praising. Finally, it is not possible to resubmit the previous application materials when supplementing the information, reducing both the burden on the enterprise and the official workload.

Article 31: If the same pesticide product fails to pass the approval three times and the applicant needs to reapply, the pesticide registration tests must be carried out again.

Comment: The failure to pass the approval three times may be caused by various reasons, but it seems completely unnecessary and scientifically unfounded to require new pesticide registration tests, especially expensive metabolic, toxicological, and environmental tests. After all, it is already normal for new pesticides to be registered several times.

Article 33: The Ministry of Agriculture and Rural Affairs will make an approval decision within 20 working days from the date of receiving the evaluation opinions. If the conditions are met, a pesticide registration certificate will be issued within ten working days. If the conditions are not met, notify the applicant in writing and explain the reasons. If an application involves multiple matters, a registration certificate will be issued for those that meet the conditions. For those that do not meet the conditions, the applicant will be notified in writing and the reasons will be explained.

Comment: This article clarifies the situation where parts of an application that involve multiple matters pass the review.

Article 37: If the holder of a pesticide registration certificate changes its name, the holder must submit relevant proof materials and apply to the Ministry of Agriculture and Rural Affairs for the renewal of the pesticide registration certificate.

If an enterprise holding a pesticide registration certificate is merged, canceled, or abandoned for pesticide production, or the achievements of new pesticide developers are transformed, the registration certificate can be transferred to the merged or transformed enterprise. Both parties involved in the merger and transformation should jointly apply to the Ministry of Agriculture and Rural Affairs, and submit relevant supporting materials, and the authority will issue a new pesticide registration certificate.

Comment: After clarifying the conditions for the transfer of registration certificates, will the renaming of the 51% shareholding company basically not meet the requirements? If the registration certificate must be renewed according to the above regulations, which type of application must be applied for? How long is the approval time? What are the relevant supporting materials, what are the supporting materials for different situations, and the specific procedures need to be clarified?

Article 38: If the validity period expires and it is necessary to continue producing or exporting pesticides to China, an application for renewal must be made within 180 to 90 days before the expiration of the validity period. If the extension is not applied for within the time limit, a new application for registration must be made.

Comment: The time limit for applying for the renewal of the pesticide registration certificate is clearly stipulated, which should not be earlier than 180 days or later than 90 days. The impact of reapplying for registration on the enterprise is quite significant!

Article 41: The Ministry of Agriculture and Rural Affairs will review the application materials for registration renewal and make a decision on whether to approve the renewal before the expiration of the validity period.

1. Those that meet the conditions will be allowed for renewal;
2. If there is no pesticide production license, registration will not be allowed for renewal;
3. If the scope of the production license does not match the pesticide registration certificate, the registration will be suspended. If the corresponding production license scope cannot be obtained within five years, the registration will not be allowed for renewal;
4. If there are safety risks to agriculture, forestry, agricultural product quality, human and animal health, or ecological environment, the target's biological resistance significantly increases or the effectiveness seriously decreases, the registration will not be permitted for renewal after review by the Pesticide Registration Review Committee; and
5. Pesticide varieties that require a periodic evaluation and the relevant evaluation reports that do not meet the requirements will not be allowed for renewal.

Comment: For applicants without a pesticide production license, registration will not be allowed for renewal! The officials really left sufficient time for enterprises with registration certificates but without production licenses to obtain them. So if they do not have a production license, they can only endure the pain.

Article 46: The competent departments at or above the provincial level will conduct a risk assessment of the monitoring results and propose early warning measures for pesticide varieties with high risk and poor effectiveness.

Comment: The authority is very professional and has fully considered the risks and effects of plant protection products in actual production and application.

Article 48: If an applicant or agent (institution) conceals relevant information or submits false pesticide registration materials and test samples, the Ministry of Agriculture and Rural Affairs will include their illegal information in the integrity file and make it public. The applicant's application for new registration items will not be accepted within one year. If the registration has been approved, the pesticide registration certificate will be revoked, and the applicant's new registration application will not be accepted within three years. If the pesticide registration certificate is revoked, the applicant's new registration application will not be accepted within five years.

If a pesticide registration specialist conceals relevant information, submits false pesticide registration materials and test samples, or interferes with registration testing and registration review work, resulting in serious consequences, they will not engage in work related to pesticide registration within ten years.

Comment: The authority is really thoughtful in considering the development of the industry, and the importance of compliance. All registered colleagues also need to pay attention!!

The above only represents personal opinions. If colleagues in the industry have any suggestions or different ideas for this draft, please promptly submit your opinions to the Ministry of Agriculture and Rural Affairs! To borrow a phrase 'gather the wisdom of everyone and incorporate good strategies from all sides', everyone can provide suggestions for the development of the industry.

CIRS has compared the current version and drafted version of "Measures on the Management of Pesticide Registration" in detail, if you need any further assistance please get in touch with us via service@jianzaoshiwang.cn.