Brazil – ANVISA modifies lists of components, usage limits, and statements for infant formulas, nutritional formulas for high-risk newborns, transitional foods and cereal-based foods for infants and young children, enteral nutrition formulas, and dietary formulas for inborn errors of metabolism

The National Health Surveillance Agency (ANVISA in Portuguese) has published Normative Instruction No. 453/2026, which amends Annexs I, II, and IV of Normative Instruction No. 367 of ANVISA, dated June 5, 2025.

  • Annex I of Normative Instruction No. 367 of Anvisa, dated June 5, 2025, published in the Official Gazette of the Union No. 109, dated June 11, 2026, Section 1, page 144, will be amended as established in Annex I of this Normative Instruction.
  • Annex II of Normative Instruction No. 367 of Anvisa, dated June 5, 2025, will be amended as established in Annex II of this Normative Instruction.
  • Annex II of Normative Instruction No. 367 of Anvisa, dated June 5, 2025, will be amended as established in Annex III of this Normative Instruction.
  • Annex IV of Normative Instruction No. 367 of Anvisa, dated June 5, 2025, will be amended to include the provisions established in Annex IV of this Normative Instruction.