Brazil has issued amendments to its food supplement labelling framework, establishing standardized lists of nutrients, bioactive substances, and probiotics with defined limits and claims, affecting a broad range of dietary supplements.
Brazil Sets New Labelling and Nutrient Rules for Supplements
All supplement labels must now follow standardized formats and approved lists.
What changed
Standardized nutrient lists are now mandatory for all food supplement labels.
Consistent labelling is required for nutrients, bioactive compounds, and health claims.
Health claims restricted to only those with scientific support.
Who it affects
Food supplement manufacturers must update product labels to meet the new standards.
Importers of supplements must ensure all products comply with the new labelling rules.
Key dates
Brazil’s Updated Food Supplement Labelling Framework
Brazil has amended its regulatory framework for food supplements through Instrução Normativa (IN) nº 28, de 26 de julho de 2018, as updated by IN ANVISA nº 450, de 10 de junho de 2026. These changes establish standardized lists of authorized constituents, usage limits, permitted claims, and labelling requirements for dietary supplements. Below is a structured breakdown of the key compliance obligations.
1. Authorized Constituents
Food supplements may only contain ingredients listed in Anexo I of IN nº 28/2018, as amended by IN nº 450/2026. This list excludes supplements for infants (0–12 months) and young children (1–3 years)1. Key inclusions:
- Nutrients (e.g., lipids like ostrich fat)1.
- Bioactive substances (e.g., caffeine, guarana fluid extract)1.
- Probiotics (e.g., Limosilactobacillus reuteri DSM 17938, Lactiplantibacillus plantarum 299V)1.
2. Minimum and Maximum Limits
Supplements must comply with population-specific daily intake limits for nutrients, bioactive substances, enzymes, and probiotics, as defined in Anexos III and IV of IN nº 28/2018 (amended by IN nº 450/2026)1.
Probiotics: Minimum Limits (Anexo III)
| Probiotic Strain | Units | 0–6 mo | 7–11 mo | 1–3 yrs | 4–8 yrs | 9–18 yrs | ≥19 yrs | Pregnant | Lactating |
|---|---|---|---|---|---|---|---|---|---|
| Limosilactobacillus reuteri DSM 17938 + ATCC PTA 6475 | UFC | 2×10⁸ | 2×10⁸ | 2×10⁸ | 2×10⁸ | 2×10⁸ | 2×10⁸ | 2×10⁸ | 2×10⁸ |
| Lactiplantibacillus plantarum 299V | UFC | — | — | 1×10¹⁰ | 1×10¹⁰ | 1×10¹⁰ | 1×10¹⁰ | 1×10¹⁰ | 1×10¹⁰ |
| Lactobacillus fermentum CECT 5716 | UFC | — | — | — | — | — | — | — | — |
Notes:
- Minimum limits for L. reuteri DSM 17938 were updated in IN nº 450/2026.
- "-" indicates no minimum requirement for the group.
Probiotics: Maximum Limits (Anexo IV)
| Probiotic Strain | Units | 0–6 mo | 7–11 mo | 1–3 yrs | 4–8 yrs | 9–18 yrs | ≥19 yrs | Pregnant | Lactating |
|---|---|---|---|---|---|---|---|---|---|
| Limosilactobacillus reuteri DSM 17938 | UFC | 3×10⁹ | 3×10⁹ | 3×10⁹ | 3×10⁹ | 3×10⁹ | 3×10⁹ | 3×10⁹ | 3×10⁹ |
| L. plantarum 299V | UFC | — | — | — | — | — | — | — | — |
Notes:
- Maximum limits for L. reuteri DSM 17938 were revised in IN nº 450/2026.
- "-" indicates no maximum limit specified.
3. Permitted Claims (Anexo V)
Claims must align with Anexo V of IN nº 28/2018, as amended by IN nº 450/2026. Examples include:
| Constituent | Authorized Claim | Composition Requirement | Labelling Requirement |
|---|---|---|---|
| EPA + DHA | "Contributes to normal heart function." | ≥250 mg combined EPA/DHA per daily serving1. | — |
| L. reuteri DSM 17938 + ATCC PTA 6475 | "May contribute to gastrointestinal health." | Must meet minimum limits in Anexo III1. | Warning: "Not for pregnant/lactating women, infants, children, immunocompromised, or severely ill individuals."1 |
| L. plantarum 299V | "May contribute to gastrointestinal health." | Must meet minimum limits in Anexo III1. | Same warning as above. |
| L. fermentum CECT 5716 | "May reduce mastitis risk in healthy lactating women." | Must meet minimum limits in Anexo III1. | Same warning as above. |
Notes:
- Claims for EPA/DHA were updated in IN nº 450/2026.
- Warnings are mandatory for probiotics listed in Anexo VI.
4. Complementary Labelling Requirements (Anexo VI)
Supplements containing specific probiotics must include the following warning on labels1: > "This product must not be consumed by pregnant/lactating women, infants, children, immunocompromised individuals, or those with severe health conditions."
Applicable strains:
- Limosilactobacillus reuteri DSM 17938 + ATCC PTA 6475.
- Lactiplantibacillus plantarum 299V.
- Lactobacillus fermentum CECT 5716.
5. Enforcement and Effective Date
- Authority: ANVISA (Agência Nacional de Vigilância Sanitária)1.
- Effective Date: IN nº 450/2026 entered into force on 10 June 2026 (publication date).
Regulation Analysis
| Regulation | Key Requirement | Threshold/Deadline | Authority |
|---|---|---|---|
| IN nº 28/2018 (Anexo I) | Only constituents listed in Anexo I are authorized for supplements1. | Immediate compliance | ANVISA |
| IN nº 28/2018 (Anexos III–IV) | Supplements must adhere to minimum/maximum limits for nutrients/probiotics by population group1. | Immediate compliance | ANVISA |
| IN nº 28/2018 (Anexo V) | Claims must match authorized wording and composition requirements1. | Immediate compliance | ANVISA |
| IN nº 450/2026 | Updates limits for L. reuteri DSM 17938 and adds new claims/warnings. | Effective 10 June 2026 | ANVISA |
Summary Answer
Brazil’s updated food supplement framework, governed by IN nº 28/2018 and IN nº 450/2026, mandates:
- Authorized ingredients (e.g., probiotics like L. reuteri DSM 17938) must be listed in Anexo I1.
- Daily intake limits for nutrients/probiotics vary by age group, with revised thresholds for L. reuteri DSM 17938.
- Permitted claims (e.g., "gastrointestinal health") require compliance with composition and labelling rules, including mandatory warnings for vulnerable groups1.
- Enforcement is immediate, with ANVISA overseeing compliance. Manufacturers must review formulations and labels to align with the updated annexes.
Sources
- ↩ members.wto.org — modification / 26 03255 00 x https://members.wto.org/crnattachments/2026/TBT/BRA/modification/26_03255_00_x.pdf