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The National Health Surveillance Agency (ANVISA) has enforced a resolution and a normative instruction that regulated food and food supplements.

These are:

  • Resolution No. 240 Categories of Food and Packaging Dispensed and With Compulsory Health Registration, Enforcement Date: July 27, 2018
    • This Resolution establishes the lists of food and packaging that are exempt and with compulsory health registration.
      • Annex I provides the list of food and packaging that are exempted to the health registration requirements.
      • Annex II provides the list of food and packaging with a compulsory health registration requirement.
  • Normative Instruction No. 28 Lists of Constituents, Limits of Use, Claims and Labeling Supplementation of Food Supplements, Enforcement Date: July 27, 2018
    • This Normative Instruction establishes the lists of constituents, limits of use, claims and supplementary labeling of food supplements.
      • Annex I lists the authorized constituents that can be used in food supplements with the exemption of food supplements for infants (0 to12 months) and children from 1 to 3 years of age.
      • Annex II lists the authorized constituents that can be used for food supplements intended for infants (0 to 12 months) and children from 1 to 3 years of age.
      • Annex III lists the minimum nutrient limits, bioactive substances, enzymes and probiotics that food supplements must supply for the daily consumption recommendation and by the population group indicated by the manufacturer.
      • Annex IV lists the maximum nutrient limits, bioactive substances, enzymes and probiotics that food supplements must not be exceeded for the daily consumption recommendation and by the population group indicated by the manufacturer.
      • Annex V lists the authorized claims for use in the labeling of food supplements and their composition and labeling requirements.
      • Annex VI lists the complementary labeling requirements for food supplements.
      • Annex VII lists the essential amino acid quantities of reference protein.

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