Chapter 1 Brazil ANVISA Regulatory information Brief

1. Eaa and Introduction

Agencia Nacional de Vigilancia Sanitaria (ANVISA) Responsible for approving and supervising the market access, sales and market compliance supervision of cosmetics.

2. Supervision and regulation

 Resolução da Diretoria Colegiada - RDC nº 907, de 19/09/2024

3. Brazilian cosmetics definition and classification

Personal hygiene products, cosmetics, and fragrances are preparations made from natural or synthetic substances that are applied to all parts of the human body, skin, hair, nails, lips, external genitals, teeth, and oral mucosa for the sole or primary purpose of cleaning, perfuming, altering/improving body odor, protecting, or keeping it in good condition.

The general regulation applicable to the market licensing of personal hygiene products, cosmetics and perfumes is RDC Resolution 07/2015 (as amended by RDC Resolution 237/2018). Only the commodities listed in Annex VIII (sunscreens and sunscreens, hair strengtheners, topical repellents and hand sanitizer gels) are subject to the premarket approval process. Other products must be registered with the Sistema de Automacao de Cosmeticos (SGAS) system. Anvisa.

4. Entry requirement

• Information of Brazilian importers with cosmetic import qualification

• Reference journal or reference for active ingredients

• Full ingredient formula table (including the purpose of use of ingredients, imported products need a copy of the original formula), technical specifications of finished products and raw materials (including sensory, physical, chemical, microbial indicators)

• Intended use, labelling and packaging of the product (technical specifications for packaging materials)

• Effectiveness data, safety data, stability data

• Manufacturing process

5. Registration language 

English + Portuguese

Chapter 2 Registration process, cycle & Government fee

1. Registration flow chart

2. Registrar's fee

Chapter 3 FAQ

Q：How long is the validity period of registration for cosmetics in Brazil?

A：All for 10 years. The validity period of the registration certificate is calculated from the date of its publication in the Diario Oficial da Uniao (DOU). The filing shall be valid from the date of promulgation.

Q：Can the registration period of cosmetics in Brazil be renewed? How to operate?

A：Registration must be revalidated within the first 6 months of the last year of the 10-year validity period and the corresponding official fee must be paid.

Q：Is the International Code of Nomenclature for Cosmetic Ingredients (INCI) still mandatory?

A：Yes, under RDC nº 752/2022, the International Code of Nomenclature for Cosmetic Ingredients (INCI) is still mandatory for the labeling of personal care products, cosmetics and perfumes.