Brazil Regulatory Status
Regulatory Agency
Agência Nacional de Vigilância Sanitária (ANVISA)
Regulatory Category(ies)
The regulation for the use in food supplements, finished product, or ingredients is released in the veterinary area.
Prebiotic Types
Fructooligosaccharides (FOS), Inulin, Galactooligosaccharides (GOS), Lactulose
Fiber Definition
For now, only fructooligosaccharides (FOS), inulin, galactooligosaccharides (GOS), and lactulose have reached the classification of prebiotics. They are categorized as fibre, found in foods by ANVISA.
Position on "Prebiotic Claim"
- Allowed; defined as fibre
- Prebiotic claims require ANVISA approval based on scientific evidence
Rationale if not permitted (Include Reference / Regulation)
Not applicable
Facts Panel Declaration (per category)
No information available
Approved Health Claim(s)
Prebiotics are non-digestible food components that beneficially affect the host by selectively stimulating the proliferation or activity of desirable bacterial populations in the individual’s colon and thus promoting health benefits.
Dose Specifics
No information available
Regulatory Submission
No information available
Claims Substantiation
No information available
Regulatory Approval Process
Mandatory pre-market review and approval for claims that must be substantiated by human clinical trials. ANVISA uses the same evidence evaluation framework as Health Canada and Food Standards Australia New Zealand ( FSANZ).
Post-Approval Process (i.e., Amendment and Renewal)
No information available
Enforcement Practice
No information available
Link to Reference Documents
No information available
If you have updated information for this page, please submit it to Regulatory Lead Tania John for review: tjohn@nutrasource.ca. Thank you.