China’s Ministry of Agriculture and Rural Affairs (MARA) has released two new agricultural industry standards that introduce standardized requirements for the evaluation of pesticide metabolites under the country’s pesticide registration framework:

• NY/T XXXX-202X — Toxicological Evaluation Procedures for Major Pesticide Metabolites

• NY/T 2882.11-202X — Environmental Risk Assessment Guidance, Part 11: Pesticide Metabolites

For the first time, China has established a comprehensive, science-based framework covering both toxicological assessment and environmental risk evaluation of pesticide metabolites. This development provides greater regulatory clarity and predictability for international companies preparing registration dossiers for the Chinese market.

Alignment with International Practices

The new standards are closely aligned with globally recognized approaches, incorporating:

• Tiered evaluation strategies

• Methodologies consistent with EFSA guidance

• Principles in line with OECD frameworks

This marks a significant step toward international regulatory harmonization, helping global agrochemical companies better align their data packages across jurisdictions.

What This Means for Agrochemical Companies

For companies developing new active substances or seeking pesticide registration in China, these standards will become essential technical references, particularly in meeting the latest requirements from ICAMA (Institute for the Control of Agrochemicals, Ministry of Agriculture). Early understanding and implementation of these requirements will be critical to ensuring efficient dossier preparation and successful registration outcomes.

Access the English Translations

To support global stakeholders, REACH24H has completed full English translations of the newly released standards:

• Environmental Risk Assessment Guidance Part 11: Pesticide Metabolites (NY/T 2882.11-202X)

• Toxicological Evaluation Procedures for Major Pesticide Metabolites (NY/T XXXX-202X)

Request your copies: Please contact us at [email protected] with your company name and specific business needs. Our regulatory experts can also provide tailored insights on how these new standards may impact your China registration strategy.

Important Disclaimer: The English versions are translated from official draft standards and are provided for reference purposes only. All regulatory submissions must strictly follow the official Chinese texts published by MARA.