The Brazilian Health Surveillance Agency (“ANVISA”) has published Resolution 998/2025, which establishes technical and procedural requirements for assessing occupational, residential, and bystander risks related to the use of pesticides and related products. The regulation complements the existing framework—which until now focused primarily on dietary risk assessment (ingestion of residues in food)—and represents a step forward in harmonizing national criteria with international risk-assessment practices.

Resolution 998/2025 regulates non-dietary risk assessment associated with pesticide use, covering workers involved in mixing, loading, application, and re-entry into treated areas, as well as residents living near application sites and bystanders who may be incidentally exposed.

Under the new rule, ANVISA requires registration applicants and holders undergoing amendments or re-evaluations to submit studies, exposure estimates, and mitigation measures compatible with the actual use scenario of each product.

The regulation creates the DAROC (Dossier for Occupational and Resident/Bystander Risk Assessment), a technical document that must accompany registration, post-registration, and review procedures. Minimum required elements include:

• identification of exposure scenarios;
• exposure estimates based on ANVISA-defined parameters;
• comparison with existing toxicological reference values;
• indication of necessary mitigation measures (PPE, re-entry intervals, operational procedures, among others).

The Resolution establishes uniform methodological parameters for estimating dermal and inhalation exposure, the use of dermal absorption data, assessment of contact with treated surfaces, characterization of application scenarios, and the definition of control measures proportional to the identified risk. This standardization aims to increase regulatory predictability and enable consistent assessments across different products and toxicological classes.

Products already registered may be required to supplement their documentation when submitting amendments that affect exposure or during toxicological re-evaluation processes.

Publication of Resolution 998/2025 entails several obligations and strategic actions, including: portfolio review to identify products requiring an updated DAROC; assessment of the need for additional studies or reprocessing of exposure data; adjustments to labeling, directions for use, and mitigation measures; and coordination with technical teams, toxicologists, and specialized consultants to ensure compliance within ANVISA’s deadlines.

We remain at your disposal to assist in analyzing the impacts of Resolution 998/2025 and supporting the necessary adjustments to ensure compliance within the established timelines.

The Resolution enters in force on May 25, 2026.

To access the Resolution in Portuguese version, click here.