Cosmetics · Brazil

Cosmetics in Brazil, on the right ANVISA route

Most cosmetics are notified to ANVISA; a few groups, such as sunscreens, need registration. Whether your company is in Brazil or coming from abroad, we define each product’s route, review formula and label, and support the filing.

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✓ISO 9001 certified in Brazil
✓Audited processes
🌐Service in PT · EN · DE

Is this for you?

Two starting points, one market

The ANVISA route is the same. What changes is who holds the product.

You are coming from abroad

You need a Brazilian holder

Only a Brazilian company with an ANVISA AFE and a local health licence can hold a cosmetic product
Sobel offers this through a qualified, approved partner
We build on your EU or US files where Brazilian rules allow

Your company is in Brazil

Your company is the holder

Your company holds an ANVISA AFE for cosmetics and a local health licence, and files its own products
We prepare the file and follow the filing with your team
Support for changes, renewals and products ANVISA questioned

What you get

One route for each product

Checked against the current ANVISA rules, from formula to filing.

Gap analysis of your products against the current ANVISA rules
Grau (1 or 2) and route: notification or registration
Formula review against the Brazilian ingredient lists
Label review in Portuguese, including the composition
Safety data sheets (SDS), when your supply chain asks for them
Holder services through our qualified, approved partner, for companies outside Brazil
Updates when ANVISA changes ingredient lists or label rules

Notification or registration?

Under RDC 907/2024, which replaced RDC 752/2022, most products are notified and a few groups need registration. We confirm the route for each product.

Most products

Notification

All groups not listed for registration, Grau 1 and Grau 2
Electronic filing with ANVISA
Sale once the notification is published on ANVISA’s portal
Every 10 years, a declaration that you will keep selling

Specific groups

Registration

Sunscreens (including children’s) and suntan products
Hair straightening and waving products
Insect repellents (including children’s) and antiseptic hand gels
Leave-on hair styling pomades (RDC 814/2023)
ANVISA reviews the file; sale after publication in the Official Gazette (DOU)
Valid for 10 years, renewable

How it works

1ReviewWe look at each product, its claims and the target consumer to assess Grau and route.
2Formula and labelWe check ingredients against the Brazilian lists and adapt the Portuguese label.
3FilingIf your company is the holder, you file with our support. If you are outside Brazil, the filing is made through our qualified, approved partner, acting as holder.
4On the marketChanges and deadlines, such as revalidations, planned in a shared calendar.

Talk to a specialist

Keep exploring

Cosmetic registration and notificationThe ANVISA procedure, step by step.→Product stuck at ANVISARejected, questioned or cancelled: what to do now.→CosmeticsOur services for cosmetics in every market.→

Why Sobel

Regulation as a business decision, not a checklist.

Four disciplines work on every project, in the same team, from the first decision to post-market.

Strategy

Classification and market sequence decided first. The right class from day one avoids rework.

Science in house

Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.

Regulatory, five markets

ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.

Technology

A dedicated technology team builds the workflows that keep every project traceable and on time.

“We know how auditors think, because we’ve been one of them.”

Maik Endler

Founder & CEO

Mechanical engineer, trained in Germany
Former BSI auditor (Notified Body)
Industry experience at Sirona (now Dentsply Sirona)

Questions, answered

Frequently asked questions

Rules cited on this page: RDC 907/2024 (replaced RDC 752/2022) · RDC 949/2024 · RDC 814/2023 · RDC 898/2024 · RDC 894/2024 · RDC 629/2022 · RDC 48/2013 · RDC 16/2014

Notification or registration: which applies to my product?

Registration applies to the groups listed in RDC 907/2024, art. 34: sunscreens (including children’s), suntan products, hair straightening and waving products, insect repellents (including children’s) and antiseptic hand gels. Leave-on hair styling pomades also need registration under RDC 814/2023. All other products are notified. We confirm the route for each product.

What is the difference between Grau 1 and Grau 2?

Under RDC 907/2024, Grau 1 covers products with basic properties that do not need initial proof; Grau 2 covers products with specific indications that require proof of safety and/or efficacy, such as sunscreens and children’s products. Grau 2 does not automatically mean registration. We assess each product against the current ANVISA lists.

Who can hold a cosmetic product in Brazil?

Only a Brazilian company with an ANVISA Company Operating Authorisation (AFE) for cosmetics and a licence from the local health authority. A Brazilian manufacturer files its own products; imported products are held by a Brazilian importer or holder. If your company is outside Brazil, Sobel offers this through a qualified, approved partner.

What does cosmetovigilance require from the holder?

RDC 894/2024, in force since 28 August 2025, sets Good Cosmetovigilance Practices for holders: a cosmetovigilance system, a designated responsible professional and the reporting of serious adverse events to ANVISA within the set deadline.

What must be on the label in Portuguese?

The mandatory information is in Portuguese, with some exceptions such as INCI names and trademarks. The composition must also be available in Portuguese, in one of the formats ANVISA allows. We review your artwork against the current rules.

Can we use our EU safety report and product file?

As supporting evidence, yes. The formula still has to meet the Brazilian ingredient lists, the evidence must be available to ANVISA and the label must follow Brazilian rules. Some tests, such as SPF for sunscreens, follow methods set by ANVISA. We tell you what can be reused.