An Overview of China’s New Policies on Pesticide Registration Management in 2022

An Overview of China’s New Policies on Pesticide Registration Management in 2022...

January

January 7, 2022 Order No. 1 of 2022 issued by the Ministry of Agriculture and Rural Affairs has revised and republished the Measures for the Administration of Pesticide Registration Trials and the Measures for the Administration of Pesticide Registration. The principal amendment is that registration trials for new pesticides have been changed from an approval-based system to a filing-based system.

March

March 11, 2022 Notice from the General Office of the Ministry of Agriculture and Rural Affairs on the Issuance of Guidelines for Field Efficacy Trials of Herbicides in Controlling Weeds in Transgenic Herbicide-Tolerant Corn and Soybean Fields.

March 17, 2022 Announcement No. 536 of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China states that, in order to ensure the quality and safety of agricultural products, the safety of humans and livestock, and the safety of the ecological environment, and in accordance with the “Opinions of the CPC Central Committee and the State Council on Deepening Reform and Strengthening Food Safety Work” and the Regulations on the Administration of Pesticides, and with the approval of the State Council, it has been decided to phase out four highly toxic pesticides—parathion‑methyl, isofenphos‑methyl, monocrotophos, and methamidophos. Effective September 1, 2022, the pesticide registrations for the technical grades and formulated products of parathion‑methyl, isofenphos‑methyl, monocrotophos, and methamidophos will be revoked, and their production will be prohibited. Products legally manufactured prior to this date may continue to be sold and used within their guaranteed shelf life; however, their sale and use will be prohibited effective September 1, 2024.

March 25, 2022 Announcement No. 542 of the Ministry of Agriculture and Rural Affairs of the People’s Republic of China: In accordance with the Regulations on the Administration of Pesticides, the Measures for the Administration of Pesticide Registration, the Measures for the Administration of Pesticide Registration Trials, the Requirements for Pesticide Registration Data, and other relevant provisions, and in order to standardize the registration and management of target herbicides used on genetically modified herbicide‑tolerant crops and to ensure the safety and efficacy of pesticides, our Ministry has formulated the “Requirements for Registration Data of Target Herbicides Used on Genetically Modified Herbicide‑Tolerant Crops,” which is hereby promulgated and shall take effect from the date of issuance. Any previously issued requirements concerning registration data for herbicides used on genetically modified herbicide‑tolerant crops are hereby repealed.

March 29, 2022 In accordance with the “Decision of the State Council on Amending and Repealing Certain Administrative Regulations,” the Regulations on the Administration of Pesticides have been revised for the second time. The principal amendment stipulates that registration trials for new pesticides shall henceforth be subject to filing rather than approval.

August

August 1, 2022 In the 21st issue of 2022 of Pesticide Registration Information, the Pesticide Registration Review Committee noted in its deliberations on relevant matters that:

(1) Regarding the registration of granular formulations: When granules are applied to the soil to control above‑ground crop pests and diseases, the application method is often crude, with limited specificity for the target pests or pathogens and relatively high application rates. Such practices fail to meet the requirements for reducing pesticide use while enhancing efficacy, pose risks to the ecological environment, and are inconsistent with the concept of green development. It is recommended that, except for the control of soilborne diseases or underground pests, granular products intended for the soil application method to manage above‑ground pests and diseases should, in principle, not be approved.

(II) Regarding the submission of toxicological data for registration of new pesticides intended solely for export. To standardize the submission of toxicological data for applications to register new pesticides for export only, applicants may submit data publicly available on the official websites of JMPR, EFSA, USEPA, and other recognized authorities. If such official data cannot be provided, a toxicological study report must be submitted; this report shall comply with the provisions of Article 16 of the Measures for the Administration of Pesticide Registration and shall be issued by a registration‑testing institution accredited by the Ministry of Agriculture and Rural Affairs or by an overseas laboratory that has entered into a mutual recognition agreement with China.

September

September 5, 2022 In the Ministry of Agriculture and Rural Affairs General Office’s Opinion on Whether Cleaning‑Type Disinfectant Products Fall Within the Scope of Pesticides, Document No. [2022] 15, it is stated: According to Article 2 of the Regulations on the Administration of Pesticides, pesticides refer to chemical synthetic substances or mixtures of such substances, as well as their formulations, which are used to prevent or control diseases, pests, weeds, rodents, and other harmful organisms that threaten agriculture and forestry, or to purposefully regulate the growth of plants and insects. Accordingly, cleaning products—such as laundry detergents, hand sanitizers, and pipe‑clearing agents—that bear label claims indicating functions like “bactericidal” or “acaricidal,” as well as disinfectant products, do not fall within the aforementioned category of pesticides and are therefore not subject to pesticide regulation.

October

October 11, 2022 In the 29th issue of 2022 of Pesticide Registration Information, the Pesticide Registration Review Committee discussed the registration of mixed formulations containing plant growth regulators. The Committee concluded that plant growth regulators are subject to strict requirements regarding application timing and dosage; improper use may lead to phytotoxicity or compromise the quality of agricultural products. Accordingly, the Committee generally does not approve the registration of mixed formulations combining plant growth regulators with insecticides, fungicides, or herbicides.

October 26, 2022 , Pesticide Registration Information, Issue No. 29, 2022. The relevant information reviewed by the National Pesticide Registration Review Committee is as follows:

(1) Registration of formulated mixtures containing total‑kill herbicides such as glyphosate or glufosinate. Given the large number of applications currently submitted for mixtures of total‑kill herbicides intended for non‑agricultural land and selective herbicides used in agricultural fields—mixtures that, in practice, pose risks of drift, misuse, and overdosing—the Pesticide Registration Review Committee recommends no longer approving the filing of registration trials for such mixed formulations. In addition, it is recommended to standardize the labeling requirements for total‑kill herbicides by prohibiting their use in agricultural and forestry areas—including field roads, field borders, inter‑row spaces of fruit trees, fallow land, and forested areas—to prevent spray drift from causing phytotoxicity to neighboring crops.

(II) Regarding the registration and management of herbicide‑tolerant crops developed through conventional breeding. The Pesticide Registration Review Committee has determined that such crops are not produced via genetic modification or gene editing; rather, they are typically obtained through methods like photomorphogenesis, resulting in traits that are inherently unstable. Consequently, registering herbicides for use on these conventionally bred, herbicide‑tolerant crops entails certain safety risks, including the potential for phytotoxicity, and thus calls for a cautious approach to crop‑specific pesticide registration. To further standardize the registration process for herbicide‑tolerant crops derived from conventional breeding, the Committee recommends that, when evaluating these varieties, the same four‑fold dosage regimen applied to genetically modified herbicide‑tolerant crops should be adopted to assess both the crop’s tolerance to the herbicide and its safety with respect to the crop.

(3) Requirements for the Approval of Pesticide Labels. In accordance with the Measures for the Administration of Pesticide Labels and Instructions, in order to further refine the review of content such as application‑specific technical requirements, product performance, precautions, first‑aid measures for poisoning, storage and transportation methods, and shelf life, and to better guide farmers in the scientific and rational use of pesticides, the Pesticide Registration Review Committee has deliberated and adopted the “Opinions on Further Refining the Requirements for the Approval of Pesticide Labels.” These opinions shall serve as a reference for applicants for pesticide registration and holders of pesticide registration certificates when preparing pesticide labels, and may also be consulted during the approval process for pesticide labels.

November

November 11, 2022 The Ministry of Agriculture and Rural Affairs has issued Announcement No. 618, approving and promulgating 30 pesticide‑related environmental impact standards— including “Chemical Pesticides: Acute Oral Toxicity Test for Birds—Part 1: Stepwise Method”—following expert review. These standards primarily cover the cultivation of biological test materials, test methods, and risk‑assessment guidelines for pesticide registration environmental‑impact studies. Effective March 1, 2023, they will further standardize environmental‑impact testing and risk‑assessment procedures for pesticide registration, thereby enhancing the reliability of registration‑test data and risk‑assessment conclusions.

Source: Agrochemical Regulatory Service Station