The Brazilian Health Regulatory Agency (Anvisa) recently updated its pesticide toxicological assessment guidelines, ensuring stricter regulatory compliance and enhanced safety for public health and the environment. These revisions, became effective on December 23, 2024, aim to modernize the assessment of potential mutagenicity, carcinogenicity, neurotoxicity, and reproductive toxicity.
The Updated Guidelines
Anvisa released updated versions of four critical guides:
- Guide 66/2023 – Potential Mutagenicity
- Guide 67/2023 – Reproductive Toxicity
- Guide 68/2023 – Carcinogenic Potential
- Guide 69/2023 – Neurotoxicity
These updates incorporate feedback from public consultations and align with legislative reforms, particularly the Pesticide Law 14.785/2023. The guidelines define advanced methodologies, procedural transparency, and enhanced evaluation criteria, benefiting the toxicological reanalysis process for existing pesticides.
Anvisa’s Reanalysis Framework
Unlike other regulated products, pesticide registrations in Brazil are indefinite. However, given the continuous evolution of scientific knowledge, Anvisa conducts reanalyses to mitigate emerging risks. This process involves identifying risks based on international research or internal recommendations. Since 2006, Anvisa has finalized 19 pesticide reanalyses and is currently reviewing four others.
The reanalysis process benefits from these updated guidelines, ensuring thorough and transparent evaluations. Public access to these documents on AnvisaLegis further emphasizes transparency and accountability.
Introducing Flora: Streamlined Toxicological Assessments
Complementing these updates, Anvisa institutionalized the Flora Tool through RDC 950/2024, effective January 2, 2025. Designed to optimize toxicological assessments for pesticides derived from equivalent technical products, Flora offers a faster, systematic, and equally reliable alternative to conventional methods.
Key features of Flora include:
- Automated data organization.
- Clear classification of product hazards.
- Alignment with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Companies must submit hazard classifications via the Declaration of Composition and Hazard Information (DCIPA) alongside Flora for new and ongoing processes by January 2, 2026.
Implications for Public Health and Safety
These updates signify Anvisa’s commitment to safeguarding public health through advanced regulatory mechanisms. By leveraging Flora and updated guidelines, the agency ensures rigorous assessments of pesticide hazards, minimizing population exposure to toxic risks while maintaining compliance with global standards.
Conclusion
Anvisa’s updates to its pesticide toxicological assessment guidelines and the implementation of Flora mark significant strides in Brazil’s regulatory landscape. Companies and stakeholders must adhere to these enhanced protocols, ensuring pesticide safety and public health protection in an evolving scientific environment.