Brazil's Food Supplement Regulations
Food supplements in Brazil are defined as “Product for oral administration, presented under pharmaceutical dosage forms intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, alone or in combination.”
REGISTRATION & NOTIFICATION
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| RDC No. 23/2000: Manual of Basic Procedures for Registration and Exemption of Obligation for Product Registration Pertinent to Food. | The Technical Regulation establishes the basic procedures for registration and exemption from the obligation to register products pertinent to the food area contained in the Annex to this Resolution. This Resolution updates Decree SVS/MS No. 120, of February 18th, 1999. | Anvisa | English | For Sale |
| RDC No. 241/2018: Requirements for Proving the Safety and Health Benefits of Probiotics for Use in Food. | This Resolution provides for the requirements for proving the safety and health benefits of probiotics for use in food. | Anvisa | English | For Sale |
| RDC No. 242/2018: The Registration of Vitamins, Minerals, Amino Acids and Proteins classified as Specific Medicines for oral use. | This resolution applies to Specific Medicines; they are medicines based on vitamins and/or minerals and/or amino acids and/or isolated proteins or combined with each other for oral use with well-established therapeutic indications and different from those established for food supplements. This resolution does not apply to food supplements included in the scope of Resolution RDC No. 243 of 26 July 2018 or its updates which do not have a therapeutic indication. | Anvisa | English | For Sale |
| RDC No. 243/2018: Food Supplements Health Requirements. | This Resolution provides for the requirements for composition, quality, safety and labeling of food supplements and for updating the lists of nutrients, bioactive substances, enzymes and probiotics, limits of use, claims and supplementary labeling of these products. | Anvisa | English | For Sale |
| RDC No. 275/2002: Good Manufacturing Practices of Food Producing/Industrializer Establishments. | To approve the Technical Regulation of Standard Operating Procedures applied to Food Producing/Industrializer Establishments and the Checklist of Good Manufacturing Practices in Food Producing/Industrializer Establishments. | Anvisa | English | For Sale |
INGREDIENTS
| Document Title | Description | Issued by | Available Languages | Download |
|---|---|---|---|---|
| Normative Instruction - IN No. 28/2018: Lists of Constituents, Usage Limits, Claims and Supplementary Labeling for Food Supplements. | This Normative Instruction establishes the lists of constituents, usage limits, claims and complementary labeling of food supplements. | Anvisa | English | For Sale |
| Normative Instruction - IN No. 76/2020: Updating the lists of constituents, usage limits, claims and supplementary labeling of Food Supplements. | This Normative Instruction establishes the lists of constituents, usage limits, claims and complementary labeling of food supplements outlined in 6 Annexes. This Norm updates previous Normative Instruction No. 28, of July 26th, 2018. | Anvisa | English | For Sale |