The normative instruction establishes the lists of authorized constituents, use limits, claims, and complementary labeling requirements for dietary supplements in Brazil. It serves as a complementary act to Resolution RDC No. 243, of July 26, 2018. It outlines approved ingredients (proteins, carbohydrates, dietary fibers, lipids, minerals, vitamins, amino acids, and other bioactive substances), specifying their chemical abstract service (CAS) numbers and permissible sources. The annexes also differentiate between ingredients allowed for the general population versus infants and young children.

Contents

Article 1: Purpose and Scope

Article 2: Annex I - Authorized Constituents for Dietary Supplements (excluding infants and young children)

Article 3: Annex II - Authorized Constituents for Infants (0-12 months) or Young Children (1-3 years)

Article 4: Hydration Degrees

Article 5: Annex III - Minimum Limits of Nutrients, Bioactive Substances, Enzymes, and Probiotics

Article 6: Annex IV - Maximum Limits

Article 7: Not Established (NE) Limits

Article 8: Not Authorized (NA) Limits

Article 9: Annex V - Authorized Claims and Requirements

Article 10: Annex VI - Complementary Labeling Requirements

Article 11: Annex VII - Essential Amino Acid Quantities

Article 12: Entry into Force

Annex I: List of Authorized Constituents