Several Core Registration Policies You Must Understand Before Initiating Product Registration

What new requirements and changes have recently been introduced in the pesticide registration review process? This article provides a summary for reference in pesticide registration work.

There are four key points to consider regarding the principles of active ingredient registration.

(1) In principle, registration of new chemical pesticide active ingredients is not approved; however, exceptions apply where, due to the substance’s characteristics, technical considerations, or safety concerns, registration of the technical-grade material cannot be sought.

(2) For chemical pesticides other than new‑type pesticides, if the applicant has not yet obtained registration for the active ingredient, the application for parent‑compound registration shall be disapproved. If the applicant obtains registration for the active ingredient prior to submitting a parent‑compound registration application, such applications shall, in principle, be subject to stringent review and submitted to the National Pesticide Registration Review Committee for deliberation.

(3) Approval of the registration of microbial pesticides and plant‑derived pesticide active ingredients;

(4) Synthetic biochemical pesticides shall be regulated as chemical pesticides, while fermented or extracted biochemical pesticides may be approved for active ingredient registration.

Requirements for Active Ingredient Registration Data

(1) For the registration of new active ingredients, submit the documentation in accordance with the requirements for technical-grade materials (active ingredients) set forth in Annex 1 of the “Requirements for Pesticide Registration Data.”

(2) For applications where the applicant has already registered the technical-grade active ingredient and its formulation, the chemical data requirements are the same as those for the formulated product; however, the report on room‑temperature storage stability may be waived. Toxicological data shall include results from six acute toxicity tests, while environmental impact data may be omitted.

Several Mitigation Scenarios for Insect Semiochemicals

Only lure-type insect sex pheromones used exclusively in traps, and confusion‑type insect sex pheromones applied solely via a carrier, may be exempted from submitting data on the mutagenicity and subchronic oral toxicity of the active ingredient (parent compound), as well as environmental impact studies; they are also exempt from providing residue and environmental impact study data for the formulated product, and from preparing a risk assessment report.

In principle, registration of the following four categories of mixed formulations will not be approved.

(1) For targets for which the combined effect of the registered active ingredients is antagonistic; and for agricultural and forestry insecticides that do not exhibit synergistic effects;

(2) Mixtures of insecticides and fungicides, as well as mixtures of insecticides or fungicides solely intended to broaden the spectrum of control, except for seed treatments;

(3) Mixing herbicides with other classes of pesticides;

(4) Mixing chemical pesticides with plant-derived pesticides.

Several Registration Issues Concerning Mixtures Containing Total‑Kill Herbicides Such as Glyphosate or Glufosinate

(1) Many formulations combine non-selective herbicides intended for non-cultivated land with selective herbicides used in agricultural fields, and their practical application entails risks such as drift, misuse, and overdosing.

(2) Registration and filing of field trial applications for mixed formulations of non-selective herbicides and selective herbicides for agricultural use are no longer permitted.

(3) Strengthen label‑labeling requirements for non‑selective herbicides and for formulations combining non‑selective herbicides with agricultural selective herbicides, and prohibit their use in agricultural and forestry areas such as field roads, field borders, inter‑row spaces of fruit trees, fallow land, and forested areas.

Definition of the Scope of Pesticide Management

(1) Bird repellent

Office of the Ministry of Agriculture and Rural Affairs Letter on the Qualitative Classification of Bird-Repellent Agents (No. 18 [2020] of the Agricultural Law Office)

(2) Differentiation from veterinary drugs

Office of the Ministry of Agriculture and Rural Affairs Letter on the Legal Definition of the Administration of Veterinary Drugs and Pesticides (Nongban Nonghan [2021] No. 3)

(3) Classification of “mosquito-repellent wristband” products

Office of the Ministry of Agriculture and Rural Affairs: Opinions on the Certification of Mosquito-Repellent Products (No. 19 [2021] of the Office of Agriculture)

(4) Opinions on the Determination of Illegally Added Substances Such as “Bromfenapyr”

Opinion of the General Office of the Ministry of Agriculture and Rural Affairs on the Identification of Bromobenzyldiamide and “CAS 500008-54-8” (No. 11 [2019] of the General Office of the Ministry of Agriculture and Rural Affairs)

Precautions for Identifying Similar Products in Liquid Dosage Forms

The quality standards for liquid dosage forms shall specify both the mass fraction and the mass concentration; only when both the mass fraction and the mass concentration of the active ingredient in a liquid formulation are identical may it be deemed to be a similar preparation.

Requirements for Metabolic Trial Data

(1) Based on the results of animal metabolism (residue), plant metabolism, and environmental metabolism studies, determine whether any major metabolites are present.

(2) If no major metabolites are identified, relevant supporting documentation may be submitted.

(3) If major metabolites are present, it is necessary to determine whether they have toxicological significance, and reports from acute and subchronic toxicity studies shall be provided.

(4) If there are toxicological implications, further toxicological study data on the metabolites shall be submitted.

(5) Toxicological test data for metabolites are not available for retrieval.

The number of significant figures for the total content of active ingredients in a formulated product shall comply with the specified requirements.

When the total content of a formulated product and the individual contents of its active ingredients cannot simultaneously comply with the requirements for significant figures set forth in the “Requirements for Pesticide Registration Data,” the total content of the active ingredients shall meet the prescribed requirements; for active ingredients with lower potency, their content may not be required to conform to the significant‑figure provisions.

Source: Huisheng Pesticide Registration Agency