Brazil: Anvisa updates toxicological evaluation guides for pesticides

The Brazilian Health Regulatory Agency (Anvisa) has revised its pesticide evaluation guidance for mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity.

Purpose of the Updated Guidelines

These guides are critical resources for assessing the toxicological concerns associated with pesticides. They provide recommended practices and methodologies for the analysis of different outcomes, ensuring a rigorous and thorough review process throughout product registration and future re-analysis.

Alignment with Scientific Advances and Legislation

Anvisa emphasises that these guidelines represent its understanding of current best practice and are in line with the latest scientific advances and regulatory requirements. The updates incorporate comments from public discussions and align with recent amendments to Brazilian pesticide regulation (Law 14,785 of December 27, 2023).

Objectives of the Revisions

The main objective of these revised guidance is to improve the transparency and clarity of the toxicological evaluation standards, especially throughout the re-analysis process.
The updated guidance is effective immediately.

Highlights of the Update

• Guidelines on pesticide mutagenicity, carcinogenesis, neurotoxicity, and reproductive toxicity have been updated.

• Improved transparency and clarity of the evaluation process.

• Included comments from public consultations and aligned with new legislative developments.

Anvisa’s Role in Pesticide Evaluation

Anvisa is responsible for the evaluation of pesticides, environmental control products, technical products, and related items in accordance with its objective of promoting and protecting the health of the Brazilian population.

Pesticide Registration and Re-Analysis

Unlike other products controlled by the Agency, the registration of pesticides is not legally subject to renewal or revalidation, and it is permanent. However, pesticides are subject to re-analysis to ensure product safety and limit possible damage. International or domestic organizations can request re-analysis.

Since 2006, Anvisa has carried out 19 re-evaluations of pesticides and is currently carrying out four re-analyses. The provision of updated instructions will increase transparency in the evaluation of these products.

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