,Agência Nacional de Vigilância Sanitária (ANVISA) published Normative Instruction No. 418, introducing amendments to the regulatory framework governing food supplements in Brazil. This update modifies the provisions originally established under Draft Resolution No. 457 of 28 December 2017, previously notified to the World Trade Organization under reference G/TBT/N/BRA/781.
Draft Resolution No. 457 laid down the foundational rules for food supplements in Brazil, establishing lists of permitted nutrients, bioactive substances, enzymes and probiotics, as well as their conditions of use, minimum and maximum intake limits, authorized claims, and supplementary labeling requirements. These provisions were implemented through earlier normative instructions and have now been revised by IN No. 418/2025 to reflect regulatory and scientific developments.
Objective of the Amendment
Normative Instruction No. 418/2025 aims to update and refine the existing regulatory framework to ensure continued consumer safety, regulatory clarity, and alignment with current scientific evidence. The amendment was approved by ANVISAs Collegiate Board and formally enacted by the Agencys Director-President.
Key Regulatory Updates
The amendment revises several annexes forming part of the food supplements regulation, including:
Authorized Constituent Lists
Updates to the lists of nutrients, bioactive substances, enzymes and probiotics permitted for use in food supplements, including specific provisions applicable to infants (012 months) and young children (13 years).
Minimum Daily Intake Requirements
Revisions to minimum levels that food supplements must provide per recommended daily consumption, differentiated by population group.
Maximum Daily Intake Limits
Updated maximum thresholds for certain nutrients and bioactive substances to prevent excessive intake and associated health risks.
Authorized Claims
Modifications to the list of claims that may be used on food supplement labels, including associated compositional and labeling conditions.
Supplementary Labeling Requirements
Additional and revised mandatory labeling statements to improve transparency and consumer understanding.
Population Groups Covered
The revised framework continues to apply differentiated intake limits and requirements based on population groups, including:
Infants and young children
Children and adolescents
Adults
Pregnant individuals
Lactating individuals
This stratified approach ensures that nutritional recommendations and safety limits are appropriate to each groups physiological needs.
Regulatory Context and Impact
The amendments introduced by IN No. 418/2025 reinforce Brazils consolidated regulatory model for food supplements, which seeks to balance market innovation with robust public health protections. By updating constituent lists, intake limits, claims and labeling rules, ANVISA provides clearer guidance for manufacturers while strengthening consumer safeguards.
Entry into Force and Compliance
Normative Instruction No. 418/2025 enters into force upon publication. Food business operators are expected to review product formulations, labeling and claims to ensure alignment with the revised requirements, including any transitional provisions applicable to products already placed on the market.