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.