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ANVISA updates regulation on food supplements

Brazil

Mar 08, 2024

The National Health Surveillance Agency (ANVISA in Portuguese) has published the Normative Instruction IN No. 284/2028 updating Normative Instruction IN No. 28/2018, which establishes the lists of constituents, limits of use, declarations and complementary labeling of food supplements.

The update covers:

I - "List of constituents authorized for use in food supplements, except food supplements indicated for infants (0 to 12 months) or young children (1 to 3 years)", established in Annex I.

II - "List of constituents authorized for use in food supplements indicated for infants (0 to 12 months) or young children (1 to 3 years)", set out in Annex II.

III - "List of minimum limits of nutrients, bioactive substances, enzymes and probiotics in food supplements, per daily consumption recommendation and by population group indicated by the manufacturer", established in Annex III.

IV - "List of maximum limits of nutrients, bioactive substances, enzymes and probiotics in food supplements, per daily consumption recommendation and by population group indicated by the manufacturer", established in Annex IV.

V - "List of authorized claims for food supplements and the respective composition and labeling requirements", set forth in Annex V.

VI - "List of supplementary labeling requirements for food supplements", set out in Annex VI.

For further information (in Portuguese), click on the Link

Check the full text of the documents (in Portuguese), click on the Link

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