Reply from the Pesticide Inspection Institute of the Ministry of Agriculture and Rural Affairs Regarding Chemical Issues in Pesticide Registration Applications

Release Date:

2025-07-24

1. In the export registration application only, the active ingredient content stated on the foreign registration certificate is 23.42%, with four significant figures. Does the product’s active ingredient content also need to comply with the requirement in Annex 12 of the “Requirements for Pesticide Registration Data,” which stipulates that “the active ingredient content shall be ≥10% or 100 g/L, and the number of significant figures for the content shall not exceed three”?

Reference response: For export‑only registrations, the principles for setting the active‑ingredient content of pesticide products as set out in Annex 12 of the “Requirements for Pesticide Registration Data” may be waived; registration applications may be submitted based on the product‑specific active‑ingredient content indicated on the foreign registration certificate.

2. When a product’s active‑ingredient content is modified in accordance with the principle of similarity, the pre‑change chemical data must be provided; however, since that pre‑change data was generated prior to 2021, it did not include testing for impurities in the active ingredient. Moreover, the post‑change quality standard has added an impurity specification for the active ingredient. Therefore, do the pre‑change quality‑control reports and the two‑year ambient‑temperature stability reports need to be supplemented with impurity‑testing results?

Reference response: When a product’s active ingredient content is modified in accordance with the principle of similarity, if the revised quality standards introduce additional control items and limits for relevant impurities, a quality‑testing report demonstrating the assay results for these impurities after the change must be submitted. It is not necessary to supplement the pre‑change quality‑testing report or the two‑year ambient‑storage stability report with additional impurity‑testing results.

3. For a product applying for registration, if the active ingredient content is changed according to the principle of similarity, can the submitted physicochemical data simply use the previously prepared physicochemical report corresponding to the earlier formulation? Or, after adjusting the formulation, must a new physicochemical report be generated based on the updated active ingredient ratio, with both the original and the revised reports submitted simultaneously?

Reference response: If the change in the content of the active ingredient during the registration process falls outside the permitted fluctuation range, it is necessary to submit the product’s composition after the change, the product quality standards, test reports on physicochemical property determinations, stability test data from three batches under thermal storage conditions and low-temperature stability test data, as well as a quality inspection report. If the change in the active ingredient content remains within the permitted fluctuation range, only the product quality standards and quality inspection report that comply with current registration requirements need to be submitted.

4. For a liquid formulation that has already been registered, if an application is submitted to increase the mass concentration, are additional documents required beyond the product quality standards and the quality inspection report? Can the thermal storage stability test and the low-temperature test specified in the quality inspection report be omitted?

Reference response: To apply for the registration certificate to increase the mass concentration, you must submit a product quality standard that complies with current registration requirements, along with a quality inspection report. The quality inspection report need only include the results of density, mass fraction, and mass concentration measurements.

Source: Pesticide Inspection Institute of the Ministry of Agriculture and Rural Affairs

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