The Brazilian National Health Surveillance Agency (ANVISA in Portuguese) published Normative Instruction IN No. 318, which updates Normative Instruction IN No. 28 that establishes the lists of constituents, limits of use, declarations and supplementary labeling of dietary supplements.
It updates:
I – List of constituents authorized for use in dietary supplements, except for dietary supplements indicated for infants (0 to 12 months) or early childhood 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 to be provided by food supplements, in the daily consumption recommendation and by population group indicated by the manufacturer”, established in its Annex III.
IV – “List of maximum limits of nutrients, bioactive substances, enzymes and probiotics that cannot be exceeded by food supplements, in the daily consumption recommendation and by population group indicated by the manufacturer”, established in Annex IV.
V – “List of claims authorized for use in the labeling of dietary 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.