Foreign Cosmetics Brands in Brazil: What ANVISA Requires

Your products already sell in Europe, the US or Korea. They have a safe formula, a compliant label and a growing fan base on Brazilian social media. But for foreign cosmetics brands in Brazil, the rulebook has changed: in 2025 and 2026, ANVISA rewrote much of it. A formula that was acceptable two years ago may now contain a restricted or prohibited substance, and a claim that works in another market may trigger a recall in Brazil.

The short answer: a foreign brand cannot notify or register cosmetics with ANVISA directly. It needs a company legally established in Brazil to hold the product regularization. Low-risk (Grau 1) products are notified, higher-risk (Grau 2) products are registered, and every formula must now be checked against the substance lists ANVISA updated in 2026.

At a glance

What changed at ANVISA in 2025–2026?

Brazil has been consolidating its cosmetics rules since 2024. For foreign brands, five changes matter most.

1. A new core regulation. RDC 907/2024 replaced the long-standing RDC 07/2015. It sets out the product definition, the Grau 1 and Grau 2 classification, labelling and packaging requirements and the regularization procedures. Several companion resolutions were issued alongside it, including RDC 898/2024 on the composition statement in Portuguese and RDC 951/2024, which moved Grau 1 filings to ANVISA’s Solicita system.

2. New substance lists. On 11 June 2026, ANVISA published two resolutions that incorporate MERCOSUR decisions into Brazilian law. According to ANVISA, RDC 1,029/2026 establishes the first part of the new list of restricted substances, and RDC 1,030/2026 updates the list of prohibited substances. RDC 1,030/2026 adds 13 entries, revises four and removes four. We covered it in detail in our RDC No. 1,030/2026 article.

3. A second restricted list on the way. Public Consultation 1,399/2026 proposed the second part of the restricted list. The draft adds 142 substances and foresees a 24-month transition for products already notified or registered. The comment period closed on 8 September 2026, so the final resolution may be published at any time.

4. Faster action on hazardous substances. RDC 995/2025 prohibited TPO and DMPT, two substances used mainly in nail products, following the EU’s lead. After a 90-day withdrawal period, ANVISA cancelled more than 500 product regularizations in March 2026.

5. New petition codes. Since 1 September 2026, requests to include a new substance, a new function, new packaging or a new physical form each have their own petition code and form. For a foreign brand whose formula contains an ingredient not yet covered by Brazilian lists, this can become the first regulatory step. Our article on the new petition codes explains the documentation required.

The practical consequence is simple: a formula approved in another market is a starting point, not a guarantee. Every ingredient and concentration needs to be checked against the current Brazilian lists.

How does a foreign cosmetics brand get access to the Brazilian market?

Can a foreign company notify ANVISA directly?

No. ANVISA states that foreign companies cannot handle pre-market authorizations directly with the agency. They need a partner company legally established in Brazil, which becomes legally responsible for the imported products.

In practice, this local company holds the notification or registration, operates with the required ANVISA operating authorization and has a technically responsible professional.

Choosing this holder is a strategic decision. Many foreign brands simply let their importer or distributor hold the filings. That works until the brand wants to change partners, add a second distributor or sell directly.

Because the holder controls the regularization, agree in advance who owns the filings, who approves changes, who reports adverse events and what happens if the commercial relationship ends. An independent holder, such as a Brazilian regulatory representative for cosmetics, keeps these options open.

Is my product Grau 1 or Grau 2?

Brazil uses two risk classes. Our guide on how cosmetic registration works in different markets explains both routes in detail. In short:

• Grau 1 (lower risk) products are notified through ANVISA’s Solicita system. There is no prior technical review, but the holder remains fully responsible for safety, quality and compliance.
• Grau 2 (higher risk) products are listed in Article 34 of RDC 907/2024 and require registration, with technical review before the product can be sold.

Classification depends on product type, ingredients and claims, not on how the product is classified elsewhere. A claim alone can move a product into Grau 2, or even outside the cosmetics category.

What else must be ready?

• Formula screening against the current prohibited, restricted, preservative, colorant and UV filter lists.
• Labelling that meets RDC 907/2024 and RDC 898/2024, including the required information in Portuguese.
• Manufacturing in line with good manufacturing practices for cosmetics (RDC 48/2013), with documentation the Brazilian holder can present on request.
• Safety and claims evidence kept up to date, because ANVISA may request documents and samples at any time, including for notified products.

Is this you?

• Your claims were written for the EU or US market and have not been reviewed for Brazil.
• Your formula contains an ingredient that does not appear in Brazilian lists or in the EU CosIng database.
• Your distributor holds your notifications, and you do not know what happens to them if you change partners.
• Your products are already sold in Brazil through cross-border e-commerce, without a local regularization.

If you answered yes to any of these, review your Brazilian strategy before your next launch.

Why are foreign cosmetics brands looking at Brazil now?

Brazil is one of the largest beauty markets in the world. According to Euromonitor data compiled by ABIHPEC, the Brazilian cosmetics, toiletries and fragrance sector reached R$ 175 billion in sales in 2025, 6.8% more than in 2024. This places Brazil third worldwide, behind only the United States and China.

ABIHPEC also reports that the sector’s exports passed US$ 1 billion for the first time in 2025, a sign of a strong local industry as well as a large consumer base.

Foreign brands are arriving in this market in growing numbers. Korean beauty is the clearest example: according to ABIHPEC, Brazil imported around 1,800 tonnes of Korean cosmetics and personal care products in 2025, worth US$ 34.6 million. International brands are also entering through specialty retail, pharmacies and e-commerce platforms.

Distribution in Brazil is broad. Beauty and personal care products reach consumers through pharmacies, supermarkets, specialty stores and franchises, direct sales, e-commerce and beauty salons. Each channel brings its own commercial partners, and often its own expectations about documentation.

For a new brand, compliance is therefore also a matter of trust: retailers and distributors increasingly check whether a product is properly regularized with ANVISA before listing it.

What are the real risks after market entry?

Notification is not the end of regulatory work. ANVISA has become more active in three areas:

Claims. Cosmetic claims must be true, demonstrable and compatible with the product category. Claims that suggest a drug-like effect, such as curing acne or stopping hair loss, are not allowed for cosmetics. In October 2025, ANVISA ordered the withdrawal of 78 products, mostly because products notified as low-risk cosmetics claimed effects beyond what a cosmetic may claim.

Cosmetovigilance. RDC 894/2024 established good cosmetovigilance practices. In its first year, from August 2025 to July 2026, ANVISA recorded 592 adverse event notifications for cosmetics, compared with 257 in the previous period, an increase of about 130%. Companies filed 536 of these reports, compared with 115 a year earlier, which shows that the industry is now actively reporting. ANVISA also trained 407 state and municipal inspectors and carried out its first pilot inspection of cosmetovigilance practices. Foreign brands therefore need a working process with their Brazilian holder to receive, assess and report adverse events.

Unregularized products. ANVISA regularly bans products sold without notification or registration, including cases where companies misused the regularization data of other products. Selling first and regularizing later is not a safe strategy.

In practice: Consider a Korean skincare brand that launches a brightening serum in Brazil through a local distributor. The serum sells well in Korea with a claim about reducing dark spots. The distributor notifies it as a Grau 1 product and keeps the original claim on the Portuguese label. Months later, an inspection finds the claim incompatible with a Grau 1 notification, and the product is withdrawn. A claim review before filing would have avoided it.

What is the outlook for 2027?

Three developments are likely to shape the next 12 to 24 months:

1. Final restricted list (Part II). Once published, brands will need to check their portfolios against 142 additional substances and plan reformulations within the transition period.
2. Closer alignment with other regulators. Many of Brazil’s new lists come from MERCOSUR decisions and follow international, often EU, references. In February 2026, ANVISA also signed an updated memorandum of understanding with Korea’s MFDS. It includes cooperation on regulatory reliance. This signals convergence, not a shortcut: products still need to meet Brazilian requirements.
3. More post-market oversight. With cosmetovigilance inspections starting and enforcement actions increasing, documentation quality will matter as much as the initial filing.

What to do now: a step-by-step plan for entering Brazil

Whether you are preparing a first launch or reviewing products already sold in Brazil, the order of work matters. Most delays come from discovering a problem after the filing, not before it.

1. Map your portfolio. List every product you plan to sell in Brazil, with its full formula, intended use, claims and packaging. Include products already sold through distributors or e-commerce.
2. Screen every formula. Check each ingredient and concentration against the current Brazilian lists of prohibited, restricted, preservative, colorant and UV filter substances. Flag substances affected by RDC 1,029/2026, RDC 1,030/2026 and the draft Part II restricted list, so that reformulation can be planned early.
3. Identify ingredients without a Brazilian reference. If an ingredient or function is not covered by Brazilian lists or by the EU CosIng database, assess whether an inclusion petition will be needed and whether the safety and efficacy evidence is sufficient.
4. Review claims and classify each product. Rewrite claims for the Brazilian market and confirm whether each product is Grau 1 or Grau 2. A claim that suggests a therapeutic effect needs to be removed, not translated.
5. Define the regularization holder. Decide who will hold the notifications and registrations in Brazil. Put ownership of the filings, change management, adverse event reporting and the exit scenario in writing.
6. Prepare labels and documentation. Adapt labels to Brazilian requirements and organize the safety, quality and manufacturing documentation that the holder must be able to present to ANVISA on request.
7. File and monitor. Submit the notifications or registrations, then keep a cosmetovigilance process and a regulatory watch running, because the substance lists will continue to change.

Sobel Regulatory View

The Brazilian market rewards brands that prepare before they file. The most common problems we see are formulas never screened against Brazilian lists, claims copied from other markets and unclear agreements about who holds the regularization.

For foreign brands, the practical message is: treat Brazil as its own regulatory market, not as an extension of the EU or the US. Screen the formula, review the claims and choose the right regularization holder first. The filing then becomes the last step, not the first.

How Sobel can help

Sobel Consult supports foreign cosmetics brands entering Brazil, from formula and label review to acting as the Brazilian regularization holder for notifications and registrations with ANVISA.

If you are planning a launch or reviewing products already on the market, see our cosmetic registration and notification services in Brazil or get in touch with us for a portfolio assessment.

Frequently asked questions

Can a foreign company register cosmetics with ANVISA directly?

No. Only a company legally established in Brazil can hold a cosmetic notification or registration. Foreign brands work through a local regularization holder.

Does an EU or US approval count in Brazil?

No. Formulas, labels and claims must be checked against Brazilian rules, even where lists follow similar international references.

Do I need to translate my label into Portuguese?

Yes. Labels must meet Brazilian requirements, including information in Portuguese under RDC 907/2024 and RDC 898/2024.

What happens to products already notified if a substance becomes restricted?

New lists usually give products already on the market a transition period, often 24 months. Check the deadline in each resolution.

Does a Grau 1 notification mean ANVISA has approved my product?

No. A notification is not preceded by a technical review. The holder remains responsible for safety, quality and compliance, and ANVISA can request documents or samples, or act against the product, at any time.

Official sources

• ANVISA – Exporting to Brazil
• ANVISA – Update of the substance lists for cosmetics (RDC 1,029/2026 and RDC 1,030/2026)
• ANVISA – New petition codes for cosmetics
• ANVISA – Minutes of public board meeting No. 3 of 4 March 2026 (MoU with MFDS)

This article provides general information based on documents available on the date of publication. It does not replace an assessment of your specific products and situation.