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Cosmetics · Brazil · ANVISA

Cosmetic notification and registration with ANVISA

From formula review to publication: we prepare each filing under the current ANVISA rules and submit it through our qualified partner, who acts as the holder. Deadlines are planned from day one.

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Is this for you?

Who we do this for

New productYou need the right filing for a product that is not yet in Brazil.

Portfolio from abroadYou want to bring several products, in a planned order.

ChangesYou changed a formula, a label or a claim of a product on the market.

RenewalsYou need to renew a registration or keep a notification active.

What you get

What we deliver

A complete, reviewed filing for each product, in the format ANVISA expects.

Route assessment per product: notification or registration
Formula reviewed against the Brazilian ingredient lists
Label artwork review, including the Portuguese composition
Summaries of efficacy and stability data and specifications
Responsibility term prepared for the holder’s signature
Filing, follow-up to publication and a calendar of deadlines

Notification and registration, side by side

The main differences between the two routes. We confirm the details for each product.

	Notification	Registration
Products	Most cosmetics, personal care products and perfumes	Specific categories, such as sunscreens, insect repellents and hair straighteners
What is filed	Formula, label artwork, data summaries, specifications and responsibility term	The same information plus what specific rules ask for the category, reviewed by ANVISA
When you can sell	Once the notification is published	After ANVISA approval is published
Over time	The holder keeps the notification active as ANVISA requires	The registration has a validity period and is renewed

How it works

1Product dossierYou send formula, labels, claims and existing safety and efficacy data.
2ReviewWe review ingredients, claims and labels and prepare the summaries ANVISA asks for.
3FilingThe holder, our qualified partner, files electronically and we follow up.
4CalendarWe plan changes, cosmetovigilance support and deadlines for each product.

Talk to a specialist

Keep exploring

Cosmetics · BrazilThe overview: Grau, routes and holder.→CosmeticsOur services for cosmetics in every market.→Find your regulatory pathSee what changes from one market to another.→

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 · RDC 949/2024 · RDC 898/2024 · RDC 629/2022 · RDC 906/2024 · RDC 772/2022 · RDC 894/2024

How long does it take?

A notified product can be sold once the notification is published. A registered product waits for ANVISA’s review. Times vary with the product and the completeness of the file, so we give you an estimate for each product.

Does ANVISA charge fees?

Yes. Fees depend on the type of petition and on the holder company. We show them separately in our proposal.

What happens over time?

Registrations have a validity period and must be renewed. Notified products also have periodic obligations to stay active. We put these deadlines on your calendar.

Do we need a certificate of free sale from the country of origin?

In general, the current rules do not ask for a certificate of free sale for cosmetics. We confirm the documents for your products in the first review.

And when we change a product?

Changes are filed according to their type, and some label changes follow a simplified procedure. We assess each change and tell you what needs to be filed.