What is ANVISA
The Brazilian Health Regulatory Agency (ANVISA) is the federal body responsible for regulating health products sold in Brazil — cosmetics, supplements, medical devices, food, sanitizers, pharmaceuticals. Equivalent to the FDA in the United States.
The context
ANVISA has been in a regulatory consolidation movement — gathering older normative acts into single, clearer rules aligned with international standards. RDC 907/2024 is the most recent example for personal care, cosmetics and perfumes.
It incorporates into Brazilian law the GMC Resolutions of Mercosur (the regional trade bloc) on definition, labeling, classification and microbiological control — which reduces complexity for companies operating in more than one country in the bloc.
What changed
- Updated definitions — categories, subcategories and risk classifications (Grade 1 and Grade 2) are clearer
- Harmonized labeling — required information, ingredient list (INCI), warnings
- Technical requirements — microbiological testing, stability, safety
- Notification/registration procedure — electronic flow through ANVISA's SOLICITA system with standardized documentation
- Post-market — vigilance and cosmetovigilance now integrate the regulatory cycle
Brazil splits cosmetics into Grade 1 (low risk — basic shampoo, perfume, soap) and Grade 2 (specific risk — sunscreen, antiperspirant, hair dye, repellent). Grade 1 = notification (immediate); Grade 2 = registration (analysis by ANVISA). Knowing your category before you arrive in Brazil avoids months of rework.
Who needs to worry
- National manufacturers of cosmetics of any size
- Importers of cosmetics — the entire chain needs to be compliant
- Private labels that outsource manufacturing — regulatory responsibility is on the registration holder
- E-commerce and marketplaces — selling unnotified cosmetics is a health violation
- Foreign brands with no Brazilian subsidiary — must work with a local Holder
Next steps for your company
- Review every SKU notified — does any need reclassification?
- Update labels still following older standards
- Verify technical files and Good Manufacturing Practices (GMP)
- Train the commercial team on permitted claims — sales pitches that go beyond regulatory approval generate fines
- Implement cosmetovigilance — system to collect and process adverse event reports
Talking to ANVISA from abroad
If your company doesn't have Brazilian legal presence, the standard model is Holder Service: a Brazilian company holds the registration on your behalf and handles all interactions with ANVISA. Time-to-market: typically months, not years.