July 07, 2025

Brazil, one of the world’s biggest cosmetics markets, has strict rules for personal care products through ANVISA (Brazilian Health Regulatory Agency). The new rule RDC 907/2024 updates the system for 2025, making it clearer, safer, and closer to global standards.

Main Rules

1. Product Classification

  • Grade 1 (Low Risk): Basic products like soap, shampoo. Only need notification, no approval.
  • Grade 2 (High Risk): Products with special claims (children’s, whitening, anti-dandruff, intimate use). I need full registration before selling.

2. Notification and Registration

  • Notification (Grade 1): Submit details online to ANVISA. Can sell right after notification.
  • Registration (Grade 2): Must send full file (safety, effectiveness, technical data). Can sell only after ANVISA approval.

3. Labeling Rules

  • Must show ingredients, expiry date, instructions, warnings, and manufacturer/importer info.
  • Labels must be clear, correct, and in Portuguese.

4. Safety & Microbiology

  • Products must pass safety tests to prove they are free of harmful germs before being sold.

5. Changes & Documents

  • From June 2025, changes to applications are allowed only before technical review starts.
  • Missing documents at submission = automatic rejection.

6. Local Partner

  • Foreign companies must have a Brazil-based partner to import and distribute products. Direct submissions from abroad are not allowed.

7. Restricted Ingredients

  • ANVISA keeps updating the list of banned or restricted substances in line with global and Mercosur standards.

Recent Updates

  • RDC 907/2024 replaced older rules, making compliance simpler and clearer.
  • Updated lists for restricted substances and allergens, with transition periods for companies.

Final Note

ANVISA’s rules for cosmetics, perfumes, and personal care products now focus on:

  • Digital submissions
  • Risk-based classification (Grade 1 vs. Grade 2)
  • Clear labeling in Portuguese
  • Strong safety checks

To stay compliant in Brazil, companies must prepare accurate documents, submit on time, and work with a local partner.