Day: 03/04/2026

Brazil – ANVISA modifies the lists of components, usage limits, and claims in dietary supplements

/ infoAlimentario

The National Health Surveillance Agency (ANVISA in Spanish) has published Normative Instruction IN No. 431 of ANVISA, dated April 1, 2026, which modifies Normative Instruction No. 28, dated July 26, 2018, that establishes the lists of components, usage limits, claims and supplementary labeling for dietary supplements.

Updates:

I – “List of authorized components for use in food supplements, except those indicated for infants (0 to 12 months) or young children (1 to 3 years old),” as stated in Annex I;

II – “List of minimum limits of nutrients, bioactive substances, enzymes, and probiotics that dietary supplements must contain, in the recommended daily intake and by population group indicated by the manufacturer,” as stated in Annex III;

III – “List of maximum limits for nutrients, bioactive substances, enzymes, and probiotics that dietary supplements cannot exceed, in the recommended daily intake and by population group indicated by the manufacturer,” as stated in Annex IV;

IV – “List of authorized claims for use in the labeling of food supplements and their respective composition and labeling requirements,” as stated in Annex V; and

V – “List of additional labeling requirements for food supplements,” as stated in Annex VI.

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Brazil – ANVISA analyzes all requests related to food additives, and there are none outside the regulatory deadline

/ infoAlimentario

The National Health Surveillance Agency of Brazil (ANVISA in Portuguese) reports that the General Directorate of Food Management (GGALI in Portuguese) has reached a historic milestone: the requests related to food additives have been analyzed, and none are past the regulatory deadline. In February and March, 62 requests were analyzed, which allowed the deadlines to be regularized.

The result is the fruit of a strategic and collective effort by the unit’s technical teams and demonstrates the effectiveness of the queue management plan adopted by GGALI, which organized and prioritized the analyzes by queue.

The operation was carried out by a team composed of four newly hired specialists in Regulation and Health Surveillance (through a public competition) and two specialists who were already part of Anvisa’s staff. The professionals worked directly on the analyzes, properly trained and integrated into the activities of the technical area, under the direction of a specialist with extensive experience in food additives.

The work also benefited from the support of the Risk Assessment and Efficacy Management Directorate (GEARE in Portuguese), as well as the teams from the Food Regulation Directorate (GEREG in Portuguese) and the Coordination of Food Standards and Regulations (Copar) in other areas, strengthening collaboration between units and the integration of GGALI teams. Currently, there are only three applications pending analysis, all of them corresponding to the year 2026.