Brazil is the only country in Latin America (LATAM) to have a well-defined legislation for functional and health claims for either nutrient or non-nutrient components and for 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 National Health Surveillance Agency (ANVISA - Agência Nacional de Vigilância Sanitária) based on safety and efficacy of the products and defines functional foods are foods and not drugs.
The Brazilian Regulatory agency responsible for the assessment of functional foods is the National Health Surveillance Agency (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’s experts assists in food product classification, formulation/ingredient assessment, label & claims review and technical dossier compilation, submission & follow up with the National Health Surveillance Agency (ANVISA).
- Food Product Classification
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Claims Consultation
- Product Registration
- Compilation, Gap Analysis and Submission of Dossier
- Interaction with ANVISA
- Legal Representation services
- Regulatory Intelligence Report
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
Strong relationship with different Health Authorities