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.

The National Health Surveillance Agency (ANVISA in Portuguese) alerts the population on the regularization, safe use and reporting of adverse events related to the consumption of infant formulas.
Infant formulas are products, in liquid or powder form, specially manufactured to meet the nutritional needs of specific audiences. These products must be registered with the Agency, as required by law, and should only be used under medical prescription by a qualified health professional, such as a pediatrician or nutritionist.
Infant formulas may be classified as foods intended for the feeding of infants (0 to 6 months of age) and/or follow-on foods for infants (6 to 12 months of age) and/or young children (1 to 3 years of age).

he Argentine Secretariat for Health and Quality and the Secretariat for Bioeconomy issued joint resolution No. 9/2024, amending the Argentine Codex Alimentaria, updating the list of additives used as carriers of vitamins and other nutrients in infant formula and clarifying the specific ingredients, definitions and labelling requirements for infant formula. It takes effect the day after it is published in the Official Gazette, and the transition period is 180 days.

• Modify the definition, classification and nutritional content of infant formula
• The formula must meet the following requirements: gluten-free, free of added fluoride (the content in readymade products shall not exceed 100ug /100kcal), lead content shall not exceed 0.01mg/kg, arsenic content shall not exceed 0.05mg/kg, etc.