The National Health Surveillance Agency (ANVISA in Spanish) has published Normative Instruction IN No. 431 of ANVISA, dated April 1, 2026, which modifies Normative Instruction No. 28, dated July 26, 2018, that establishes the lists of components, usage limits, claims and supplementary labeling for dietary supplements.
Updates:
I – “List of authorized components for use in food supplements, except those indicated for infants (0 to 12 months) or young children (1 to 3 years old),” as stated in Annex I;
II – “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that dietary supplements must contain, in the recommended daily intake and by population group indicated by the manufacturer,” as stated in Annex III;
III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that dietary supplements cannot exceed, in the recommended daily intake and by population group indicated by the manufacturer,” as stated in Annex IV;
IV – “List of authorized claims for use in the labeling of food supplements and their respective composition and labeling requirements,” as stated in Annex V; and
V – “List of additional labeling requirements for food supplements,” as stated in Annex VI.