Guide to Pesticide Packaging Compliance in China: Standards and Testing

In order to ensure the safety of pesticide products during storage and transportation, and protect the health of farmers and consumers, China’s regulatory authority has formulated a series of regulations and standards to manage the production, sale, and use of pesticide packaging. Proper testing of packaging materials is also required during the registration process. The following are some key points regarding pesticide product packaging materials in China: Standard Specifications for Pesticide Product Packaging Materials Pesticide product packaging should comply with the general requirements outlined in GB 3796-2018 General Rule for Packing of Pesticides. Additionally, emulsion products should also adhere to the requirements specified in GB 4838-2018 Packaging for Emulsifiable Concentrates of Pesticides. Both standards were implemented on January 1, 2020. According to these standards, the packaging of pesticide products should meet the following requirements: it should be sturdily and tightly sealed, with firm padding, clear markings, and appropriate weight, and…

Sep. 28th, 2023

Mastering Active Ingredient Content Requirements in China Pesticides

Understanding the regulations and requirements for active ingredient content in technical material (TC), technical concentrate (TK) and formulation products is crucial for ensuring compliance and successful pesticide registration. In this article, we will delve into the key considerations and guidelines for setting active ingredient content, empowering you to navigate the complexities of China\’s pesticide registration process with confidence. Part 1: Setting Active Ingredient Content in Technical Material / Technical Concentrate The minimum active ingredient content (% W/W) should be specified for the technical material (TC), which normally should not be less than 90%. The lower limit of the active ingredient content is usually the mean value of the five-batch analysis minus three times of the standard deviation (- 3SD). If the TC has multiple isomers, and the content of one or more isomers has been purposefully increased, the ratio of the isomers should also be indicated. The content of the…

Sep. 13th, 2023

Summary of Precautions for Registering Mixed Preparations in China

Registering mixed preparations in China requires careful attention to various factors due to their complex nature. Compared with single active ingredient preparation, mixed preparation offers advantages such as improved control effect, expanded control range, reduced pesticide dosage, and lower production cost, and it delays the development of resistance. However, the registration process for mixed preparations involves detailed documentation. In this article, we provide a comprehensive summary of the precautions and considerations necessary for successfully registering mixed preparations in China. Content Proportion and Formula Design To ensure successful registration, adhere to the following guidelines:  Limit the number of active ingredients to two in mixed preparations. Mixed preparations involving herbicides, seed treatment agents, and pheromones should not exceed three active ingredients. Avoid registering mixed preparations with three or more components for pesticides and fungicides, except for seed treatment agents. Limit the number of proportion types to three for mixed preparations with the…

Aug. 17th, 2023

ICAMA\’s \”Enterprise Open Day\” Enhances Pesticide Registration Communication in China

Since May 2023, the Institute for the Control of Agrochemicals of the Ministry of Agriculture and Rural Affairs (ICAMA) of China has launched the \”Enterprise Open Day\” program in order to improve its service mode and service level. This initiative provides pesticide manufacturers, enterprises exporting pesticides to China, and new pesticide developers (hereinafter referred to as \”enterprises\”) with the opportunity of face-to-face communication, enabling them to discuss technical issues, seek solutions, and offer valuable suggestions. By allowing enterprises to participate in the \”Enterprise Open Day\” prior to submitting their pesticide registration applications, ICAMA facilitates direct interaction between authorities and enterprises. This engagement enables fruitful discussions, enhances mutual understanding of technical matters, and assists enterprises in clarifying doubts or concerns regarding new pesticides, products, and technologies. It also helps enterprises mitigate registration risks, streamline their testing or registration plans, and safeguard their interests effectively. To apply for the \”Enterprise Open Day,\”…

Aug. 17th, 2023

Biochemical Pesticide Registration in China: Advantages and Compliance Challenges Analysis

Biochemical pesticides are an increasingly popular alternative to traditional chemical pesticides in China. However, registering and complying with regulations for biochemical pesticides in China requires a detailed understanding of the relevant laws and policies. This article provides an overview of biochemical pesticides in China, including their definition, registration data requirements, compliance costs, cycle time, and challenges. What is Biochemical Pesticides in China? According to Announcement No.2569 of China’s Ministry of Agriculture and Rural Affairs (MoARA), biochemical pesticides refer to pesticides that are naturally produced or have the same structure as natural compounds, allowing for differences in the proportion of isomers. These pesticides have no direct toxicity to the control objects but only have special effects such as regulating growth, interfering with mating, or attracting. Biochemical pesticides in China include chemical information substances, natural plant growth regulators, natural insect growth regulators, natural plant elicitors, and other substances that meet the definition…

Jun. 21st, 2023

China’s Acute Toxicity Test and Grading Standard for Pesticides: A Comprehensive Guide

In China, pesticide products must undergo registration toxicology tests before they can be sold. The acute toxicity test is an important part of risk assessment for pesticides. It is used to determine the health hazards of the test substance when orally, dermally, or via inhalation administered to animals once or several times within 24 hours. The results of the test are used to assess the potential risks posed by the substance to human health and the environment and to develop appropriate safety measures and control strategies. Toxicology tests cover various aspects of acute toxicity, including acute oral toxicity, acute dermal toxicity, acute inhalation toxicity, eye irritation/corrosion, skin irritation/corrosion, and skin allergy (sensitization). Acute oral toxicity test assesses the health hazard effects of the test substance when orally administered to the test animals once or several times within 24 hours. Acute dermal toxicity test assesses the health hazard effects of continuous…

Jun. 21st, 2023

New US EPA Rule Expedites Use of Plant-Incorporated Biotech to Protect Crops from Pests

On 25 May 2023, US Environmental Protection Agency (EPA) released a final rule that will accelerate the use of plant-incorporated biotechnologies to protect against pests. The rule will exempt a class of plant-incorporated protectants (PIPs) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). The goal of this rule is to protect public health and the environment while reducing costs for the regulated community, in line with Executive Order 14081 on advancing biotechnology. The rule may also result in increased research and development activities, commercialization of new pest control options for farmers (particularly in minor crops such as grapes and cucumbers), and reduced use of conventional pesticides. What is PIP? All plants naturally contain mechanisms to help them withstand pathogens and other pests. In its…

Jun. 02nd, 2023

U.S. EPA Seeks Public Comment on Pesticide Application Guidance for Endangered Species

The U.S. Environmental Protection Agency (EPA) has released draft guidance to improve the efficiency of EPA\’s Endangered Species Act (ESA) analyses for new pesticide active ingredient applications and active ingredients undergoing registration review. The guidance aims to fulfill requirements outlined in the Pesticide Registration Improvement Act of 2022 (PRIA 5) and further, EPA\’s 2022 ESA Workplan to protect listed species from exposure to pesticides. PRIA 5 mandates that EPA develop and issue guidance to registrants, which this draft guidance fulfills. The draft guidance is applicable to new conventional and biopesticides for outdoor use and existing conventional and biopesticides for outdoor use that are being reevaluated under registration review. While the draft guidance does not create any new requirements for applicants, the recommendations in the guidance will help applicants address potential effects to listed species for new active ingredients and registration review actions. The recommendations focus on identifying where a pesticide…

May. 26th, 2023

China’s ICAMA Reveals Key Changes in Revised Draft of Measures on Pesticide Registration Management

On May 12, 2023, the Institute for the Control of Agrochemicals, Ministry of Agriculture of China (ICAMA) published the draft Measures on the Management of Pesticide Registration for public hearing. This article is to extract several key changes that may attract attention within the draft. Possible Acceptance of Overseas OECD-GLP Data Reports in Applications Registration test reports must be conducted in China-GLP-certified labs or overseas labs recognized under a mutual agreement between the respective governments. However, efficacy trials, residual tests, and environmental fate tests that are closely related to Chinese environmental conditions should be conducted in China. Overseas test reports may be accepted to expedite the registration of a new pesticide with novel active ingredients based on local conditions, as determined by the Ministry of Agriculture (MoA) and expert committee. Applicants must submit Chinese translations of overseas test reports. Key Points in Dossier Submission and Evaluation Applicants cannot submit supplemental…

May. 23rd, 2023

China’s ICAMA Reveals Key Changes in Revised Draft of Measures on Pesticide Registration Management

On May 12, 2023, the Institute for the Control of Agrochemicals, Ministry of Agriculture of China (ICAMA) published the draft Measures on the Management of Pesticide Registration for public hearing. This article is to extract several key changes that may attract attention within the draft. Possible Acceptance of Overseas OECD-GLP Data Reports in Applications Registration test reports must be conducted in China-GLP-certified labs or overseas labs recognized under a mutual agreement between the respective governments. However, efficacy trials, residual tests, and environmental fate tests that are closely related to Chinese environmental conditions should be conducted in China. Overseas test reports may be accepted to expedite the registration of a new pesticide with novel active ingredients based on local conditions, as determined by the Ministry of Agriculture (MoA) and expert committee. Applicants must submit Chinese translations of overseas test reports. Key Points in Dossier Submission and Evaluation Applicants cannot submit supplemental…

May. 23rd, 2023
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