Analysis of Pesticide Registration in China, the United States, and Europe, and How to Make an Action Plan

Abstract: Chinese agrochemical companies have deeply integrated into the international market. While focusing on the domestic market, they are accelerating their expansion into overseas markets, especially global key agrochemicals markets such as China, the United States, and the European Union. This article examines the necessity of strategic positioning in key global markets, product market analysis, pre-registration risk assessment, registration data review criteria in different countries. The article analyzes pesticide registration in China, the United States, and Europe, as well as provides insights on how to effectively make a plan and execute the registration process.

Keywords: Registration Regulations and Strategies in China, the United States, and Europe; Analysis of Key Challenges.

1. The Necessity of China's Agrochemical Industry in Global Key Agrochemicals Market Layout

The global key agrochemicals market layout has become a driving force for the growth and expansion of China's agrochemical companies. Successful product layout and registration are essential to yielding substantial returns for these companies. Overseas multinational agrochemical corporations strategically plan registrations in global key markets for their new products. They forecast product market and peak number, establish global registration core data, and swiftly initiate registrations in key markets.

Currently, it is important for agrochemical companies to pay attention to risk mitigation in registration with increase of the pesticide registration difficulty. This article focuses on analyzing the registration requirements and considerations in key global agricultural chemical markets such as China, the United States, and the European Union, in order to help Chinese companies reduce risks and successfully register their products.

2. Product Market Analysis

It is important to perform thorough market analysis when conducting product research and selection, The United States, China, the European Union, and Brazil are key global agrochemicals markets. Companies should analyze major crops, target pests, pesticide usage, key competitors, sales volume, and prices in each market. This analysis helps evaluate potential registration countries and regions, target crops and pests, post-launch sales and market potential, and assists in making decisions regarding product investment and future prospects.

3. Pay Attention to the Registration Data Review Criteria of Each Country and Conduct Pre-registration Risk Assessment for Product Registrations.

3.1 Different registration data review criteria

The pesticide registration review criteria differ to some extent among China, the United States, and the European Union. The US Environmental Protection Agency (EPA) adopted a risk assessment approach, where products with appropriate control measures and low risks to human health and environment are deemed acceptable. The European Union has the strictest evaluation system globally, considering both environmental and health risk assessments. There are certain data evaluation criteria under which a product cannot be registered when evaluating its toxicity and environmental data, including:

Health Toxicity: 1A and 1B carcinogens; 1A and 1B mutagens; 1A and 1B reproductive toxicants.

EU Environmental Concerns: PBT (Persistent, Bioaccumulative, and Toxic); POP (Persistent Organic Pollutants); vBvP (very Persistent, very Bioaccumulative); Endocrine Disrupting Chemicals.

In addition to conducting health assessment and environmental risk evaluation, China also examines the toxicological data of products during the registration process. There are certain data evaluation criteria under which a product cannot be registered in China, including:

1. Products with acute toxicity are classified as highly toxic or extremely toxic, except for rodenticides and avermectins.

2. Pesticide formulations with dermal acute toxicity classified as highly toxic or above, and indoor hygiene formulations with dermal acute toxicity classified as moderately toxic or above.

3. Pesticide formulations that are corrosive to the eyes and hygiene formulations directly applied to the skin that cause severe eye irritation.

4. Pesticide formulations that are corrosive to the skin and hygiene formulations directly applied to the skin that cause moderate skin irritation or above.

5. Pesticide formulations with sensitization intensity classified as strong or above, and hygiene formulations directly applied to the skin with sensitization intensity classified as mild or above.

6. Pesticides with delayed neurotoxicity and/or mutagenicity and/or teratogenicity and/or carcinogenicity.

7. Microbial pesticides with pathogenicity.

3.2 Pre-registration risk assessment for product registration

Pre-registration for environmental and health risk assessment is an essential measure to ensure pesticide registration. By analyzing similar compound products, understanding their health toxicity and environmental behavior, conducting necessary toxicological tests, environmental behavior studies, and ecotoxicological tests, an evaluation of the toxicity of active ingredients and environmental risks can be performed. Reasonable deductions can be made for major metabolites, and main impurities can be inferred through synthetic routes. Evaluation of the genetic toxicity of impurities and metabolites can be conducted using tools such as (Q)SAR, read-across, and data bridging. This helps assess the registration risk and increase the success rate of pesticide registrations.

4. Registration Regulations and Procedures in Different Countries

The registration regulations and management of pesticides in the United States, the European Union, and China have their own characteristics, summarized as follows:

4.1 The European Union

EU pesticide management includes two major categories: plant protection products and biocidal products, regulated respectively by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA). The EU is responsible for the registration of active substances, while member states in the registration process are responsible for the approval of formulations. The EU pesticide regulation, Regulation (EC) No 1107/2009, categorizes pesticides into the following groups: chemical pesticides, microbial pesticides (including viruses), basic substance regulation, and candidates for substitution. The scope of regulation includes active substances, safeners, synergists, authorization of formulated products, and adjuvants. In August 2017, Regulation 2017/1432 introduced the category of "low-risk active substances". This regulation revised Regulation 1107/2009 and set out criteria for low-risk active substances, which enjoy faster review times compared to conventional products, a registration validity period extended to 15 years upon approval, an extended period of data protection for up to 13 years, and the completion of the review process within four months.

The European Union adopted a 'hazard-based' approach to determine whether pesticide active substances will be approved. The EU active substance registration is divided into the approval of new substances, the Technical Equivalence (TE) review of existing substances, and substance reassessment. In theory, the review period for conventional pesticides is 2.5-3.5 years, with an initial approval validity period of 10 years and a subsequent registration period of 15 years. For basic substances, once approved, they are theoretically registered indefinitely. The TE review process takes approximately 4 months. However, the EU's review process has experienced significant delays in recent years.

Formulation registration is conducted at the member state level and involves member state product registration, mutual recognition within the region, and formulation reassessment.

4.2 USA

Pesticide registration in the United States is divided into federal registration and state registration. The United States Environmental Protection Agency (EPA) is responsible for federal pesticide registration. The relevant pesticide registration regulations include the Federal Insecticide, Fungicide, and Rodenticide Act, the Pesticide Registration Improvement Act, the Federal Food, Drug, and Cosmetic Act, and Title 40 of the U.S. Code of Federal Regulations. Pesticide registration in the United States is classified into two types: biopesticides and chemical pesticides. To encourage biopesticide registration, the data requirements for registration are relatively minimal. The pesticide registration process in the United States includes establishment registration, pesticide product registration, and distributor registration. The registration process begins with establishment registration, followed by determining the product registration type, conducting data gap analysis, and obtaining the necessary data. There are three types of pesticide registration: R332, for active ingredients with unregistered sources, requiring the submission of a complete set of new data, with a review period of 24 months; R333, for active ingredients with unregistered sources, allowing either full or selective data referencing and requiring the applicant to have a complete set of data or authorization letter for data referencing, with a review period of 11 months; R334, for active ingredients with unregistered sources, allowing selective data referencing, with a review period of 12 months.

Data Categories:

A. Exclusive Use Data: For the initial registration of products containing new active ingredients or newly formulated active ingredients, as well as for the registration of changes to these initially registered products. The data protection period is 10 years from the date of approval, and authorization and data compensation are required for data referencing.

B. Compensable Data: Data submitted for applications such as new product registration, new use registration, or change registration. The data protection period is 15 years from the date of data submission, and data compensation is required for data referencing.

C. Other Data: Registered data that has passed the data protection period, publicly available literature, and data generated by the government.

Formulation Registration:

R310: For the registration of new products with active ingredients that have already been registered. The review period for this registration category is 7 months.

R300/R301: For the registration of identical or similar products. The review period is 4 months for cases where complete data referencing (R300) or selective data referencing (R301) is used.

State Registration: State registration is required before a product can be placed in the market of a specific state. The review period for state registration can vary from a few days to several months, depending on the specific state's requirements and procedures.

The primary registrant of a product registration certificate is the owner of the registration, while distributors are considered secondary registrants. Each distributor is required to have its own company identification number and apply for distributor registration.

4.3 China

The Ministry of Agriculture and Rural Affairs of China is responsible for pesticide registration in China, and the Institute for the Control of Agrochemicals, the Ministry of Agriculture and Rural Affairs (ICAMA) is specifically responsible for the review of pesticide registration data. Since 2017, the new "Data Requirements for Pesticide Registration" have been implemented. China's pesticide registration follows a risk-based approach for pesticide safety assessment and implements domestic Good Laboratory Practice (GLP) testing management procedures. Currently, only domestic GLP reports are accepted as registration data.

Pesticide registration in China is categorized into chemical pesticides, biochemical pesticides, microbial pesticides, and plant-derived pesticides. Technical registrations are classified as new technical registration, non-identical technical registration, and identical technical registration, while formulations are classified as new formulation registration, identical formulation registration, and similar formulations registration. Different registration types have different requirements for registration data, emphasizing the integrity and scientific review of the data.

According to the current pesticide approval process, new pesticides are reviewed by the National Pesticide Registration Evaluation Committee in biannual committee meetings, while other registrations with already approved active ingredients are reviewed by the Executive Committee of the National Pesticide Registration Evaluation Committee at monthly meetings. The review period generally takes 8-12 months.

4.4 The main similarities and differences in pesticide registration between the European Union (EU), the United States, and China are as follows:

5. Preparation of Registration Data

5.1 Preparation of Registration Data of Multinational Companies

One common requirement for registration data in various countries worldwide is for companies to provide information on the product's chemistry, toxicology, efficacy, residues, and environmental behavior to assist regulatory authorities in assessing the product's impact on human health, food safety, and environmental safety. When multinational companies prepare registration data for new products, they typically follow the data requirements of the European Union (EU) and the United States (US) when preparing OECD-GLP core data for global registration. However, when registering in different countries, additional country-specific data may need to be provided. Currently, China does not accept overseas OECD-GLP reports and requires testing to be conducted in China-GLP laboratories.

5.2 Notice for Experimental Arrangements

5.2.1 When arranging experiments for the registration of a new pesticide, it is advisable to conduct them in batches based on the results of preliminary risk assessments in order to reduce registration risks.

5.2.2 When simultaneously arranging China-GLP and OECD-GLP experiments, considerations should be given to the specific considerations for each type of test.

5.2.3 Laboratory Selection: Prior to arranging the experiments, a site investigation and assessment should be conducted for the registration test laboratories. It is recommended to select 2-3 laboratories to carry out the experiments. For OECD-GLP laboratories and Chinese GLP laboratories, REACH24H conducts reviews and establishes a laboratory database to select the appropriate laboratory for the experiments.

5.2.4 Experiment Supervision: Experiment supervision is a critical factor in the successful completion of experiments. It involves reviewing the experiment protocol, staying updated on the progress of the experiments, effectively communicating with the laboratory, and reviewing the experiment’s reports and providing timely feedback.

Article by: REACH24H Consulting Group China (Frank, Jinping GUO; Ivy, Jingjing ZHANG; Nancy, Jin'er SHEN)

Any inquiry or for more information about the services of REACH24H Consulting Group China, please contact: Daisy Hu (huke@reach24h.com).

This article is published in AgroPages' Annual business publication - <2024 CROs & CRAOs Manual>.

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