Food & Food Supplements registration in Brazil

Dietary Supplements and Foods – Overview

In Brazil, dietary supplements and foods are regulated by the National Health Surveillance Agency (ANVISA).

The regulatory requirements applicable to foods and dietary supplements vary depending on the product classification, formulation, intended use, and the claims intended to be communicated.

Freyr provides comprehensive regulatory support for foods and dietary supplements in Brazil, including:

• Product classification
• Definition of the regulatory strategy
• Ingredient and formulation assessment
• Labeling and claims review
• Preparation of technical documentation
• Regulatory process support and authority interactions

Our approach facilitates market access, minimizes regulatory risks, and ensures ongoing compliance.

Product Classification

Foods and Dietary Supplements in Brazil

In Brazil, the proper classification of foods and dietary supplements is a fundamental element, as it defines the applicable regulatory requirements, particularly with respect to labeling, composition, ingredients, and claims.

Food product compliance in Brazil follows the criteria established by ANVISA and requires registration, notification, or communication of the beginning of manufacturing or importation, depending on the product’s classification and risk level.

In the case of food supplements, for example, these are subject to notification, which must occur prior to commercialization.

The required documentation and applicable procedures are defined by the Agency’s specific regulations, which vary according to the product category and its characteristics.

Dietary Supplements

According to ANVISA, dietary supplements are product for oral ingestion, presented in pharmaceutical forms, intended to supplement the diet of healthy individuals with nutrients, bioactive substances, enzymes or probiotics, isolated or combined.

Their composition, labeling, and claims are subject to the criteria established by ANVISA, with the aim of ensuring regulatory compliance and preventing misleading interpretations by consumers.

Under Brazilian sanitary regulations are defined the authorized therapeutic claims for use on the labeling of dietary supplements. No other therapeutic attributes or medicinal properties can be mentioned in the labeling of these products, besides the ones described in the legislation.