Food Supplements registration in Brazil - Overview

Brazil is the only country in Latin America (LATAM) to have well-defined legislation for functional and health claims for either nutrient or non-nutrient components and the demonstration of safety and efficacy. The Brazilian Regulatory framework for functional and health claims for either nutrient or non-nutrient components has been developed by the National Health Surveillance Agency or the Agência Nacional de Vigilância Sanitária (ANVISA), based on the safety and efficacy of products and the categorization of functional foods under “Food” and not “Drug”. Food supplements registration with ANVISA is a crucial step for companies seeking to introduce their functional food products into the Brazilian market.

The Brazilian Regulatory agency responsible for the assessment of functional foods is Agência Nacional de Vigilância Sanitária (ANVISA), which has approved claims on a case-by-case basis, with the scientific advice of the Technical and Scientific Committee on Functional Food and Novel Ingredients (CTCAF). The “Food Supplement” category was created in 2018 to guarantee the population's access to safe and quality products. The term “supplement” applies only to minerals, vitamins, or a combination of both. Freyr Regulatory experts assist with food product classification, formulation/ingredient assessment, label and claims review, technical dossier compilation, food supplements registration with ANVISA, and food product approval in Brazil.

Food Supplements registration in Brazil - Freyr Expertise

• Food Supplement Classification.
• Formula Review/Ingredients Assessment.
• Label and Claims Review.
• Claims Consultation.
• Compilation, Gap Analysis, and Submission of Dossier.
• Legal Representation (LR) Services.
• Regulatory Intelligence (RI) Report.

Food Supplements registration in Brazil - Advantages

• End-to-end Regulatory consultation with Agência Nacional de Vigilância Sanitária (ANVISA).
• A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc.
• Support in region-specific Food Regulatory services in Brazil.
• An extensive partnership network across the globe.
• A strong relationship with various Health Authorities (HAs).