The National Health Surveillance Agency (ANVISA) has implemented important regulatory measures to improve the toxicological evaluation of pesticide products in Brazil. This is an unprecedented strategy by the agency, consisting of analysis and inspection actions, focusing on regulatory efficiency and maintaining technical rigor.
In this context, ANVISA has begun a series of on-site technical visits to industries in the pesticide sector, with the objective of verifying “in loco” the compliance of the information submitted in registration processes with the production processes and current regulations.
Basically, ANVISA seeks to compare:
– The information presented in the registration processes;
– The technical data submitted to the Agency;
– The actual production process adopted by the company.
The first visit was carried out in December 2025 at the company Nortox (PR), and for this year, an annual schedule of visits is being prepared, previously agreed upon with the companies that will be inspected.
Given this scenario, we recommend immediate attention to the company’s regulatory processes and suggest that companies:
✔ Review the regularity of ongoing processes;
✔ Check the need for amendments with FLORA and DCIPA (RDC 950/2024);
✔ Validate the consistency between technical documents and manufacturing practices;
✔ Assess regulatory risks before future submissions;
✔ Prepare for possible technical visits by ANVISA.
For questions or more information on the subject, please contact our Environmental and Regulatory team.Our team is available to: a) Conduct preventive regulatory audits in companies; b) Review the strategy of dossiers submitted to the agency; c) Support responses to requirements; d) Accompany regulatory inspections; and e) Train internal teams for regulatory inspections.
Evelini Oliveira de Figueiredo Fonseca | evelini.fonseca@nascimentomourao.adv.br
Partner of the Environmental, Regulatory and Biodiversity Law area.
