Comprehensive Analysis: Key Points of the Draft Data Requirements for Pesticide Registration in China

On July 31, 2026, China's Ministry of Agriculture and Rural Affairs (MARA) released the draft revised version of the Data Requirements for Pesticide Registration for public comment, with a deadline of August 21. This revision represents a major update that will exert a profound impact on pesticide registration and management in China over the next five to ten years.

In this article, the Agrochemical Business Division of CIRS Group provides a comprehensive overview of the main regulatory changes, analyzing their implications, and offering decision-making references for pesticide registration and R&D personnel.

Detailed Breakdown of the Major Changes

1. Adjustment of Data Requirements for New Active Ingredients

The data requirements for new active ingredients have been adjusted: some items have been added, some reduced, and certain testing items modified.

• Chemical New Active Ingredients (TC): Conditions for exemption/waiving of subacute (subchronic) inhalation toxicity test data have been added, alongside an optional benthic organism chronic toxicity test requirement. Requirements for avian short-term dietary toxicity, soil leaching, and earthworm acute toxicity tests have been removed, while the earthworm reproduction toxicity test has become mandatory. For hydrolysis test data, a requirement has been added stating that if major metabolites are likely to exist, the test must qualitatively and quantitatively evaluate them. Metabolism test data requirements have been relocated to the Technical Material (TC) section.
• New TCs for Indoor Public Health Pesticides and Repellents: Ready biodegradability tests and activated sludge respiration inhibition toxicity tests have been added.
• Microbial Pesticides: For herbicides, an algae growth inhibition test has been newly added.
• Botanical Pesticides (TC): Test items such as avian reproduction toxicity, fish early-life stage toxicity, and Daphnia magna reproduction toxicity have been newly added. Meanwhile, several tests have been reduced, such as avian short-term dietary toxicity and earthworm acute toxicity.

CIRS Comments

• Making the subacute (subchronic) inhalation toxicity test conditional is a significant positive development for the industry, aligning with international standard practices. This test is expensive and time-consuming; the long queues for 28-day or 90-day repeated inhalation exposure studies for new pesticides and non-equivalent TCs will become history.
• The addition of ready biodegradability and activated sludge respiration inhibition toxicity tests for indoor public health pesticides aligns with the environmental testing requirements for New Chemical Substance Notification under the Ministry of Ecology and Environment (MEE).
• Data requirements for botanical pesticides have been raised considerably: first, the number of test items has increased significantly; second, substances eligible for exemption from high-tier toxicological studies have been restricted strictly to approved health food and pharmaceutical ingredients, with food additives removed.

2. Adjustment of Pesticide Registration Categories and Abolition of Equivalent TC and Equivalent Formulation Registration Types

The draft regulations adjust the submission categories for pesticide registration, abolishing the registration types for "equivalent TC" and "equivalent formulation." The former equivalent and non-equivalent TC registration categories are consolidated into "TC (TK) registration after six years from the date of initial registration." Similarly, equivalent formulations and similar formulations are merged.

For TC registration after the data protection period, the draft requires that the active ingredient content must not be lower than the highest content among registered TCs, and the applicant must possess a corresponding pesticide production license. This clause protects the principle of "adhering to the highest standard" for TC quality, preventing low-content TCs from disrupting the registered product framework. Provided enterprises meet product quality standards and production licensing requirements, the data requirements for this registration category are drastically reduced—requiring only product chemistry and 3 acute toxicity study reports, which greatly benefits TC manufacturers by accelerating product launch.

CIRS Comments

• Previously, data requirements for non-equivalent TCs were excessively high, requiring large-scale toxicology studies and metabolite ecotoxicology studies. The new rules significantly lower the threshold for off-patent TCs while establishing clearer product quality requirements.

3. Lowering Data Requirements for Similar Formulations, Requiring Testing Post-Reference Product Registration

The draft requires that registration testing for similar formulations must be filed after the reference product has obtained registration. This avoids the timeline mismatch risk of "testing completed prior to reference product registration." However, data requirements for similar formulations are substantially reduced: compared to existing requirements, if application timing, dosage, and frequency are identical to those of the reference product, applicants only need to submit product chemistry and general information.

CIRS Comments

• While data requirements are reduced, the registration timeline for applicants seeking similar formulation registration is not shortened.

4. Changes to Definitions and Data Requirements for Major Pesticide Metabolites

The definition of major pesticide metabolites has been expanded. In addition to the original criterion of Total Radioactive Residue (TRR) 10%, a quantitative threshold of residue > 0.05 mg/kg has been introduced. Furthermore, major metabolites resulting from hydrolysis, aqueous photolysis, and soil photolysis are now included in the evaluation scope, expanding the overall scope of major metabolites.

Toxicological test requirements for major pesticide metabolites have undergone significant adjustments, moving away from a "one-size-fits-all" approach as detailed below:

If confirmed by environmental or residue metabolism studies, major metabolites and other metabolites/degradation products requiring evaluation must provide mutagenicity test reports, including the Salmonella typhimurium reverse mutation assay (Ames test), in vitro mammalian cell gene mutation assay, and in vitro mammalian cell chromosome aberration test. If any of these three tests yields a positive result, an in vivo mammalian bone marrow micronucleus assay (or in vivo mammalian chromosome aberration test) and an in vivo mammalian cell Unscheduled DNA Synthesis (UDS) assay (or Comet assay) must be added.

• Based on mutagenicity test results and the chemical structure of the active ingredient, dietary and environmental risk assessments for metabolites shall be conducted using the Threshold of Toxicological Concern (TTC) approach. If dietary or environmental risks are unacceptable, supplementary reports such as acute oral toxicity and subchronic (subacute) oral toxicity studies must be provided. Generally, a subchronic oral toxicity test report should be submitted; if a subacute oral toxicity report is submitted, the subacute oral toxicity report of the parent compound must be provided simultaneously.
• If the parent compound exhibits risks of reproductive toxicity, teratogenicity, or carcinogenicity, the major metabolite/degradation product must be used as the test substance to perform the corresponding studies.
• If available data indicate that the major metabolite/degradation product requires further evaluation, test items shall be added based on safety assessment needs, such as acute neurotoxicity, reproductive toxicity, teratogenicity, and chronic toxicity/carcinogenicity combined study reports.

5. Revisions to Microbial Pesticide Management Policies

Under current data requirements, microbial pesticides are managed at the strain level. The draft revision explicitly states that, in principle, microbial pesticides will be registered using the source microorganism's "Genus + Species (+ Subspecies)" as the active ingredient name, accompanied by the specific strain code. New strains will no longer be managed as new active ingredients.

CIRS Comments

• New strains of microbial pesticides will no longer need to apply for new active ingredient common names. It will no longer be possible for universities or research institutes to apply for new strains of already registered species without manufacturing setups.
• New microbial entities entering the pesticide market must obtain a production license before applying for new strain registrations of registered species. The registration pathway for new strains under existing species is greatly simplified, favoring the expansion of microbial pesticide product lines.

6. Clarification of Data Transfer Requirements

The draft clearly defines the scope of data transfer eligibility as new pesticide developers and pesticide manufacturing enterprises, specifying that applications utilizing transferred registration data must submit relevant documentation according to Annex 10. Registrations intended solely for export cannot be transferred.

CIRS Comments

• This is beneficial for data transfers between new pesticide developers and pesticide production enterprises. However, it is disadvantageous for overseas pesticide registration data holders seeking to transfer data.

7. Classification of Public Health Pesticides Adds "Household Gardening Pesticides"

The classification of public health pesticides is expanded from two categories ("household hygiene insecticides" + "environmental health insecticides") to three, adding "household gardening pesticides." This category is defined as low-toxicity or micro-toxicity public health pesticides used without dilution in limited spaces such as residential yards, rooftops, indoors, and balconies to prevent and control diseases, insect pests, and harmful organisms affecting non-edible ornamental plants, or to purposefully regulate plant growth. The draft also specifies that Technical Materials (TC/TK) intended solely for processing repellents and indoor public health pesticides shall not be used to process household gardening pesticides.

8. Detailed Rules for Authorized Data Use

For pesticides containing new active ingredients that have obtained initial registration, the draft differentiates between "TC Authorization" and "Formulation Authorization" during the 6-year period from the date of registration, detailing the specific conditions required for each authorization type.

9. New Management Requirements for Designated Adjuvants

The revision clarifies that "designated adjuvants" refer to exogenous tank-mix adjuvants that cannot be added during pesticide formulation processing due to safety or stability reasons and can only be added at the time of application. Furthermore, pesticide products utilizing designated adjuvants must submit physico-chemical properties and environmental impact data for the designated adjuvant, as well as efficacy, residue, toxicology, and ecotoxicology test data for the pesticide product combined with the designated adjuvant.

10. Full Digitalization and Phase-out of Paper Submissions

In the future, registration applications will require only standardized electronic dossiers, and original paper documents will no longer be accepted. Files must be formatted and uploaded to the Pesticide Management Information Platform by technical volumes and standardized entries. Acceptance, correction, and review will occur entirely online, drastically reducing the costs of document mailing and sorting.

Summary and Recommendations

This draft revision of pesticide registration data requirements establishes more detailed, risk-based tiered evaluation and management requirements for new active ingredients. Data requirements for TCs and formulations whose patent and data protection periods have expired are significantly reduced, benefiting TC and formulation enterprises in developing new products and expanding into global markets.

China's pesticide regulations and policies continue to evolve. Enterprises are advised to review ongoing or planned registration projects, evaluate the impact of the new regulations, and prepare in advance. CIRS is ready to assist you in leveraging policy opportunities to obtain pesticide registrations efficiently.

Why Choose CIRS for Pesticide Registration?

The Agrochemical Business Department of CIRS Group is committed to providing global pesticide and fertilizer product registration services and professional regulatory technical consulting for domestic and international enterprises. Services include registration agency for plant protection products, biocides, and public health pesticides, pesticide risk assessments, as well as registration and filing for various fertilizers (including microbial, water-soluble, and trace element fertilizers). All team members hold master's degrees or higher, with core members comprising senior regulatory experts from top global agrochemical companies possessing extensive technical experience in agrochemical registration strategies, filing workflows, data requirements, and risk assessments.

As a professional pesticide registration service provider, the Agrochemical Business Division of CIRS Group provides comprehensive regulatory consulting services, including China's new pesticide registration, RNA pesticide registration, registration scheme design for microbial and polypeptide/protein pesticides, GLP laboratory screening, and risk assessments.

Free Webinar

To help pesticide companies and industry better understand the regulatory changes, the Agrochemical Division of CIRS Group will hold a free webinar on August 28, focusing on the impact of the new pesticide data requirement in China on the industry. Click here for more details.