The National Health Surveillance Agency (ANVISA in Portuguese) has published Regulatory Instruction No. 373/2025, amending Regulatory Instruction No. 28 of July 26, 2018, which establishes the lists of ingredients, limits of use, property declarations, and supplementary labeling for food supplements.
Updated:
I – “List of ingredients authorized for use in food supplements, except those indicated for infants (0 to 12 months) or young children (1 to 3 years)”, included in Annex I;
II – “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide, according to the recommended daily intake and by population group indicated by the manufacturer”, included in Annex III;
III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements may not exceed, according to the recommended daily intake and per population group indicated by the manufacturer,” contained in Annex IV;
IV – “List of claims authorized for use on the labeling of food supplements and their respective composition and labeling requirements,” contained in Annex V; and
V – “List of supplementary labeling requirements for food supplements,” contained in Annex VI.