ANVISA cosmetic registration in Brazil

Cosmetic registration in Brazil is governed by ANVISA Resolution RDC 907/2024, which replaced RDC 907/2024 and splits cosmetics, personal-hygiene products and perfumes into two grades. Grade 1 products go to market by electronic notification. Grade 2 products, those with a specific claim or a restricted ingredient, file technical and safety data with the notification, and a listed subset, sunscreens and products for children among them, still goes through registration, a dossier review that takes months. The grade comes from the regulation and the label copy, and one claim can move a product. In every case the holder is a Brazilian company with a CNPJ and an AFE (Autorização de Funcionamento de Empresa) from ANVISA, and finding that holder is often the longest lead item.

Which route does my cosmetic take: notification or registration?

RDC 907/2024 draws the line. Grade 1 covers products whose basic properties do not require detailed proof of safety or efficacy, a shampoo or a moisturiser without claims, and they clear by notification, which ANVISA records without a technical assessment. Grade 2 covers products with a specific purpose or a restricted ingredient: antiperspirants, anti-dandruff shampoos, products for children, anything with an SPF. Most Grade 2 products are notified with their technical data attached. The ones the regulation lists for registration, sunscreens and children's products among them, wait for a dossier review.

A single ingredient or a single claim moves a product upward. "Hydrating" is Grade 1; "anti-wrinkle" or "SPF 15" makes it Grade 2. Settle the label copy before the grade, and the grade before the artwork is printed.

Who can hold the registration in Brazil?

A Brazilian legal entity with a CNPJ, an AFE (Autorização de Funcionamento de Empresa) from ANVISA covering the activity in question, importing cosmetics, and a local health licence (licença sanitária) from the state or municipal vigilância sanitária. An importer without those cannot hold your product however willing it is, and an AFE for medical devices does not cover cosmetics.

The holder is also the legal responsible party. It answers to ANVISA for the product, keeps the technical file and handles recalls. This is the item that sets the critical path most often. Verify the AFE and its listed activities on ANVISA's public consultation before the dossier work starts.

What goes into the dossier?

The formulation with INCI names and percentages, the manufacturing process, stability data, the safety assessment, microbiological results and the Portuguese labelling artwork. Most of it exists only inside the manufacturer and is not something a consultant can generate. Where a product is already sold in the European Union under Regulation (EC) 1223/2009, the Product Information File covers most of the science. It does not cover the form: Brazil expects its own structure, its own required statements and Portuguese labelling.

Some restrictions differ. Brazil keeps its own lists of permitted preservatives, colourants and UV filters, so a formulation that passes the EU annexes can still contain something outside the Brazilian list. Check the ingredient lists first. It is the cheapest check in the project and the one that changes the formulation.

What about supplements and medical devices?

The same logic runs through the other categories ANVISA regulates. Medical devices follow RDC 751/2022: Classes I and II are notified, Classes III and IV are registered, and the holder needs an AFE for devices. Food supplements follow RDC 243/2018. The grade or class decides the route, and the route decides the timeline.

Notification against registration

A change of formulation or of claim can move a product from one column to the other. Confirm the grade before the artwork is printed.