Brazils National Health Surveillance Agency (ANVISA) has officially published Normative Instruction (IN) No. 431 dated April 1, 2026, introducing significant amendments to the countrys core regulatory framework governing food supplements. The regulation came into force on April 2, 2026, and updates the earlier IN No. 28/2018, which serves as the foundational legislation for supplement composition, usage limits, health claims, and labelling requirements.
A key update is the expansion of the list of authorized constituents (Annex I). Newly permitted ingredients include lipid sources such as baru almond oil and Schizochytrium sp. microalgae oil rich in DHA, along with bioactive substances derived from aa, including aa polyphenols and anthocyanins from freeze-dried aa concentrate. The regulation also introduces specific probiotic strains such as Bifidobacterium animalis subsp. lactis CCT 7858 and Streptococcus salivarius K12, as well as a defined multi-strain probiotic combination with fructooligosaccharides (FOS). Importantly, these inclusions do not apply to supplements intended for infants (012 months) and young children (13 years).
The regulation establishes minimum intake thresholds (Annex III updates) for newly introduced substances. For adults (?19 years), minimum daily intake levels include:
1.Aa polyphenols: 200 mg/day
2.Anthocyanins from aa: 36 mg/day
3.Bifidobacterium animalis subsp. lactis CCT 7858: 1 10? CFU/day
4.Streptococcus salivarius K12: 1 10? CFU/day (also applicable from 4 years onwards)
Multi-strain probiotic blend: 8 10? CFU/day, with 2 10? CFU per strain, plus 12 g FOS
Correspondingly, maximum intake limits (Annex IV updates) have been defined to ensure safe consumption levels. For adults:
1.Aa polyphenols: 825 mg/day (maximum)
2.Anthocyanins from aa: 150 mg/day (maximum)
For probiotics, no explicit maximum limits (NE: Not Established) have been set, aligning with current scientific risk assessments.
The amendment also introduces new authorized health claims (Annex V updates). These include:
1.Vitamins B1 (thiamine), B6, and B12 claims related to normal nervous system function, contingent on meeting minimum compositional thresholds
2.Probiotic-specific claims such as gastrointestinal health support for Bifidobacterium animalis strains
3.A risk-reduction claim for Streptococcus salivarius K12 indicating potential to reduce the risk of upper respiratory tract infections in individuals over 3 years
4.A combined claim for multi-strain probiotics with FOS supporting gut health
Further, supplementary labelling requirements (Annex VI updates) have been strengthened with mandatory warning statements. Notably:Products containing freeze-dried aa concentrate must carry a warning against use by pregnant or breastfeeding women and children.Probiotic-containing products must include restrictions for immunocompromised individuals and those with serious health conditions. Multi-strain probiotic formulations additionally restrict use in children under 3 years
Overall, IN No. 431/2026 represents a precise and structured regulatory advancement, directly impacting formulation design, labelling strategy, and market authorization processes for food supplements in Brazil.
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