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Brazil’s National Health Surveillance Agency (ANVISA) has proposed Draft Resolution no. 457 Lists of Nutrients, Bioactive Substances, Enzymes and Probiotics of Food Supplements.

This proposal establishes the lists of nutrients, bio-active substances, enzymes and probiotics, limits of use, claims and supplementary labelling of food supplements. This proposal sets the following:

  • Annex I defines the list of probiotics and source ingredients of nutrients, bioactive substances and enzymes authorized for use in food supplements.
  • Annex II sets out the list of minimum levels of nutrients, bioactive substances, enzymes and probiotics to be provided by dietary supplements in the daily recommendation for consumption and by the population group indicated by the manufacturer.
  • Annex III sets out the list of maximum levels of nutrients, bioactive substances, enzymes and probiotics which cannot be exceeded by food supplements in the daily recommendation for consumption and by the population group indicated by the manufacturer.
  • Annex IV sets out the list of claims authorized for use on the labelling of food supplements and their composition and labelling requirements.
  • Annex V sets out the list of supplementary labelling requirements for food supplements.
  • Annex VI defines the list of essential amino acid quantities of the reference protein

Consultation is open for this proposal until April 9, 2018.

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