Brazil – ANVISA has published regulations regarding sanitary requirements for infant formulas, nutritional 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.