Every cosmetics brand that wants to sell in Brazil has to go through Anvisa, the national health surveillance agency. The good news: for most products the process is simpler than it looks — and when manufacturing is handled by an already-licensed laboratory, much of the regulatory work is settled before your project even begins.

This guide explains how registration works for personal hygiene products, cosmetics and perfumes, what changed in the recent rules, and what falls to the factory versus what falls to the brand.

Informational content, updated July 2026. It does not replace a regulatory assessment of your specific product. It covers the Brazilian market; registration in the destination country, in the case of export, is the importer’s responsibility.

In one sentence: most cosmetics are exempt from registration and reach the market through prior notification within days. Only nine product groups require prior registration with an Anvisa review — and grade 2 is not one of them.

The current regulatory framework

Since late 2024, cosmetics registration in Brazil has been governed principally by RDC No. 907/2024, which consolidated definition, classification, labelling, packaging, microbiological control and registration procedures into a single resolution. The classification list was updated by RDC No. 949/2024, which brought Mercosur GMC Resolution No. 18/2023 into national law.

Two changes matter for anyone launching a brand.

Registration is electronic. The whole process runs through Anvisa’s Solicita platform, which replaced the former SGAS system.

What determines the route is the Article 34 list. The rules retain the risk classification of grade 1 and grade 2, but the procedure is determined by the product groups listed in Article 34 of RDC 907/2024: those on the list are subject to registration; all others are exempt from registration and follow the prior notification route with Anvisa.

Exempt from registration: the route for most products

Most cosmetics — creams, serums, lotions, oils, soaps, shampoos, conditioners, hair masks, make-up generally, perfumes — are exempt from registration. The procedure is prior notification through Solicita.

The holding company submits the product information electronically (composition using INCI nomenclature, labelling data, intended use), together with a Statement of Responsibility signed by the Technical Officer and the Legal Representative. Commercialisation is permitted from the moment the registration is published on the Anvisa portal — typically a short window, a matter of days.

Exempt from registration does not mean exempt from obligations. The holder must keep the product information dossier up to date and available to inspectors, demonstrate safety and quality on request, use only permitted ingredients at authorised concentrations, and keep labelling compliant. The exemption simplifies the route to market, not the duty of compliance — and Anvisa audits notifications, cancelling those found non-compliant.

Exempt products are not subject to renewal, but the holder must declare an interest in continuing to sell every ten years.

Subject to registration: the more closely supervised products

Some groups require prior registration, with a technical review by Anvisa before commercialisation. The Article 34 list in RDC 907/2024 is closed — these nine groups, and only these:

Tanning products
Hand sanitiser gel
Hair straightening products
Hair straightening and colouring products
Hair waving products
Sunscreen
Children's sunscreen
Insect repellent
Children's insect repellent

Grade 2 does not mean mandatory registration. This is the most common confusion on the subject. Risk classification and the registration requirement are distinct: Article 35 establishes that groups not listed in Article 34 are exempt from registration and follow prior notification — even when classified as grade 2.

An anti-dandruff product, a product for acne-prone skin, or a children's cosmetic can be grade 2 and still follow the prior notification route.

For products intended to hold or style hair, the temporary conditions of RDC 814/2023 apply.

For those, the process involves a full technical dossier — safety and efficacy data, stability testing, formulation assessment — submitted through Solicita and reviewed by Anvisa. Commercialisation can only begin after the registration is published in the Official Gazette. Review time varies with complexity and is usually a matter of months. Sunscreens carry additional requirements of their own, including SPF substantiation.

Registration is valid for ten years, renewable for equal periods, with the renewal request filed in the first half of the final year of validity.

What the factory settles before your project begins

Registering a product presupposes a chain of authorisations held by the manufacturing company, which must be in place before any notification or registration: a Company Operating Authorisation (AFE) from Anvisa for the class of products manufactured, a health licence from the competent authority, and compliance with Good Manufacturing Practices, verified by inspection.

Hibiscus holds full licences across every regulatory sphere relevant to cosmetics manufacturing in Brazil — Anvisa, IBAMA, CETESB, the Civil Police, the Federal Police and the Army (DFPC). When your brand manufactures with us, that layer is already settled: what remains is the registration of your product, and we work on that alongside you.

Labelling: where most mistakes happen

Labelling requirements were updated recently and apply to all products, registered or exempt. RDC 898/2024 requires the ingredient list to appear in Portuguese as well as in INCI nomenclature. RDC 902/2024 requires a prominent “new formula” declaration whenever the formulation changes. The classic requirements remain: product name and purpose, directions for use, warnings and restrictions, batch, expiry date, and identification of the manufacturer and the technical officer.

Labelling is one of the most common causes of queries and rejections — and it is part of what we handle during development, so the product reaches registration already compliant.

Who holds the registration?

A point that often raises questions in private label projects: registration is filed in the name of the holding company, which can be the brand or the manufacturer, depending on how the project is structured. To be the holder, however, the company must meet the health requirements for its activity — Article 37 of RDC 907/2024 requires a Company Operating Authorisation (AFE) from Anvisa for the product class and a licence from the competent health authority. Where the brand does not yet have that structure, holding the registration in the manufacturer’s name can be assessed. Each arrangement has implications for technical responsibility, flexibility to change supplier, and the cost of fees, which vary with company size. That decision is part of designing the project, and we advise case by case.

Frequently asked questions

How long does it take to register a product that is exempt from registration? Prior notification usually clears the product for sale within days of a correct submission. The critical time is earlier: development, stability testing, and preparation of the dossier and labelling.

Can a sunscreen be registered as an exempt product? No. Sunscreen is among the products subject to registration and requires efficacy substantiation. Treating a product that requires registration as exempt is a health infraction, subject to penalties and cancellation of the registration.

Does a vegan or clean beauty product change the regulatory route? Not in itself. The procedure is determined by the product’s group and purpose, not by its marketing positioning. The claims, however, must be truthful and substantiable — and that is something we assess in the formulation.

Do I need a Brazilian company registration and an AFE to launch my brand? To hold the registration, yes: the company needs an AFE from Anvisa for the product class and a health licence. If your brand does not yet have that structure, the registration can be held by the manufacturer. We settle this at briefing.

Does Anvisa require animal testing? No. Recognised alternative methods are accepted — and Hibiscus does not test on animals.

Developing a product and want to understand the regulatory route before investing? Anvisa registration is part of what we deliver, from the technical dossier through to prior notification or registration. Talk to a specialist or see how we develop your formula.

Anvisa cosmetics registration: the guide for your brand