The National Health Surveillance Agency (ANVISA in Portuguese) has published Normative Instruction IN No. 361/2025, which amends Normative Instruction IN No. 28/2018, which establishes the lists of components, limits of use, declarations and supplementary labeling of food supplements.

Amendments:

I – “List of components authorized for use in food supplements, except for food supplements intended for infants (0 to 12 months) or young children (1 to 3 years)”, contained in Annex I;

II – “List of minimum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide, in the recommended daily intake and by population group indicated by the manufacturer”, contained in Annex III;

III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that food supplements cannot exceed, in the recommended daily intake and by 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 requirements for the supplementary labeling of food supplements”, included in Annex VI.

Art. 2 The “List of components authorized for use in food supplements, except for food supplements intended for infants (0 to 12 months) or young children (1 to 3 years)” in Annex I of Regulatory Instruction – EN No. 28 of 2018, enters into force with the addition of the components listed in Annex I of this Regulatory Instruction.

Art. 3 The “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that food supplements must provide in the recommended daily consumption and by population group indicated by the manufacturer” in Annex III of Regulatory Instruction – IN No. 28 of 2018, will enter into force with the addition of the limits listed in Annex II of this Regulatory Instruction.

Sole paragraph. Footnote iii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 4 The “List of maximum limits of nutrients, bioactive substances, enzymes, and probiotics that cannot be exceeded by food supplements in the recommended daily intake and by population group indicated by the manufacturer” of Annex IV of Regulatory Instruction – IN No. 28, of 2018, will enter into force with the addition of the limits listed in Annex III of this Regulatory Instruction.

Sole paragraph. Footnote ii is changed to “As cholecalciferol. 1 μg of cholecalciferol = 40 IU of vitamin D = 0.3333 μg of calcidiol.”

Art. 5. The “List of Authorized Declarations for Use in the Labeling of Dietary Supplements and the Respective Composition and Labeling Requirements” in Annex V of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the addition of the declarations listed in Annex IV of this Regulatory Instruction.

Art. 6. The “List of Supplementary Labeling Requirements for Food Supplements” in Annex VI of Regulatory Instruction – IN No. 28 of 2018 will enter into force with the incorporation of the supplementary labeling requirements listed in Annex V of this Regulatory Instruction.

Art. 7. A period of 24 (twenty-four) months is established for the adaptation of the labeling of food supplements that contain any of the constituents provided for in this Regulatory Instruction and that have been regularized before the National Health Surveillance System by the date of publication of this Regulatory Instruction.