Brazil Food Product Approvals: ANVISA Advances Regulatory Efficiency for U.S. Food Companies
On February 19, 2025, the Brazilian Health Regulatory Agency (ANVISA) approved a new rule to streamline the evaluation of food-related petitions by accepting supporting documentation from equivalent foreign regulatory authorities. This decision represents a significant step in aligning Brazil’s regulatory processes with international standards, creating new opportunities for U.S. companies seeking market access.
The new procedure applies to various aspects of food safety and regulation, including packaging materials, additives, processing aids, novel foods, and veterinary drugs. This development aligns with Brazil’s existing regulatory framework, offering greater transparency and predictability for companies navigating the approval process.
This initiative is part of ANVISA’s 2024-2025 Regulatory Agenda, which focuses on the admissibility of foreign regulatory analyses. The process included public consultation, in which industry stakeholders, including international companies, actively participated.
The agency emphasized that the measure will enhance ANVISA’s efficiency by optimizing resources. This shift is expected to improve response times, benefiting both regulatory authorities and businesses.
A transition period will ensure a smooth adjustment for previously submitted requests. U.S. food and ingredient manufacturers looking to expand into the Brazilian market should closely monitor these changes, as they present new opportunities for streamlined regulatory approval and faster market entry.
For more information about the new legislation and about opportunities for U.S. companies in the Brazilian market please contact:
Diogo Pinto
Commercial Specialist
U.S. Commercial Service – Brazil
Email: diogo.pinto@trade.gov