Brazil to Review Regulation for Foods for Special Dietary Purposes

On 17 November, the National Agency for Sanitary Surveillance (ANVISA) held a Sectoral Dialogue on foods for special dietary purposes. The meeting aimed to present and discuss two regulatory proposals currently under development:

• Proposal for a Normative Instruction (IN) establishing the periodic update of IN 367/2025, which sets out the lists of constituents, usage limits and claims for infant formulas, nutrient formulas for high-risk newborns, transitional foods and cereal-based foods for infants and young children, enteral nutrition formulas and dietetic formulas for inborn errors of metabolism.

• Proposal for a specific amendment to Resolution RDC 976/2025, which lays down the health requirements for infant formulas, nutrient formulas for high-risk newborns, transitional foods and cereal-based foods for infants and young children, enteral nutrition formulas and dietetic formulas for inborn errors of metabolism, with the aim of correcting unintentional substantive changes.

This initiative seeks to promote transparency and dialogue with the regulated sector and other stakeholders, enabling the exchange of technical information and clarification of doubts regarding the proposed changes.

ANVISA's Board of Directors is expected to discuss the proposals on 10 December, ahead of their planned release for public consultation.