Highlights of the 10th Regular Public Meeting of the Board of Directors

Among the regulations approved by the Board of Directors is the regulatory harmonization with Mercosur standards on personal hygiene products, cosmetics, and perfumes.

Regulatory Instructions

The Board of Directors also approved three periodic Regulatory Instructions (IN) updates related to the components of food and dietary supplements, all under the direction of Director Daniela Marreco.

• Amendment to IN 367/2025, which deals with the lists of components, usage limits, and authorized declarations 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.

• Amendment to IN 211/2023, which establishes the technological functions, maximum limits, and conditions of use for food additives and technological aids authorized for use in food.

• Amendment to IN 28/2018, which establishes the lists of components, usage limits, declarations, and supplementary labeling for food supplements.

The National Health Surveillance Agency (ANVISA) has issued Normative Instruction ANVISA No 414/2025, which amends Normative Instruction IN No. 367/2025, establishing the lists of components, usage limits, and property claims for infant formulas, nutritional formulas for high-risk newborns, transitional foods, 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 released Normative Instruction No. 367/2025, which outlines the lists of components, usage limits, and property declarations 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 therapy formulas for congenital metabolic disorders.

The National Health Surveillance Agency (ANVISA in Portuguese) has issued Resolution No 976/2025, which outlines the health requirements 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 therapy formulas for congenital metabolic disorders.
This Resolution is applicable to:

I – Infant formulas for infants;
II – Follow-on infant formulas for infants and young children;
III – Infant formulas for specific dietary therapy needs;
IV – Nutritional formulas for high-risk newborns;
V – Transitional foods for infants and young children;
VI – Cereal-based foods for infants and young children;
VII – Pediatric formulas for enteral nutrition;
VIII – Standard formulas for enteral nutrition;
IX – Modified formulas for enteral nutrition;
X – Nutritional modules for enteral nutrition; and
XI – Dietary formulas for congenital metabolic disorders.

The National Health Surveillance Agency (ANVISA in Portuguese) has published the presentation the revision and consolidation of the regulation on infant and young child formulae, transitional and cereal-based foods for infants and young children, enteral nutrition formulae and dietary formulae for metabolic errors.