ANVISA Requirements for Cosmetics in Brazil: Registration, Labelling, and Import Process

Key Points

• Cosmetic product registration in Brazil is mandatory before import or commercialization — managed exclusively by ANVISA, Brazil’s national health regulatory authority.
• Products are classified as Grade I (notification only) or Grade II (full registration with stability studies required), following RDC 949/2024.
• Before registering any product, your company must first obtain an Operating License (Licença de Funcionamento) and an AFE (Autorização de Funcionamento Empresa) from ANVISA.
• The import process for cosmetics runs through PAFCO — the specific ANVISA health surveillance post for cosmetics, sanitizers, and personal hygiene products — via the Portal Único Siscomex.
• Foreign companies without a local legal entity in Brazil must appoint a local representative or work with an Importer of Record (IOR) to hold product registrations and manage import compliance.

Index

1. What Is ANVISA and Why It Matters for Cosmetics
2. Step 1: Company Certification Requirements
3. Step 2: Product Classification — Grade I vs Grade II
4. Step 3: Notification vs Registration
5. Step 4: Labelling Requirements for Brazil
6. Step 5: The Import Process with ANVISA
7. Working Without a Local Entity: The IOR Solution
8. Frequently Asked Questions
9. Conclusion

What Is ANVISA and Why It Matters for Cosmetics

Cosmetic product registration in Brazil is governed by ANVISA — the Agência Nacional de Vigilância Sanitária — a federal regulatory agency linked to the Ministry of Health. Before any cosmetic, personal hygiene product, or perfume can be imported and sold in Brazil, it must be authorized by ANVISA. No exceptions.

ANVISA oversees the entire lifecycle of regulated products: from company authorization and product registration through to import clearance and post-market surveillance. Its scope covers the coordination of ports, airports, borders, and customs facilities, which means cosmetics arriving in Brazil face ANVISA inspection before they can enter the market. For companies unfamiliar with the Brazilian regulatory environment, this is often the first — and steepest — compliance hurdle.

Brazil is the fourth-largest cosmetics market globally, with annual consumption exceeding US$22.9 billion according to ABIHPEC, the Brazilian cosmetics industry association. The scale of the opportunity is real, but so is the regulatory complexity. Understanding ANVISA’s requirements from the outset — company authorization, product risk classification, registration or notification, labelling, and the import petition process — is what separates successful market entries from costly delays.

Step 1: Company Certification Requirements

No cosmetic product can be registered or notified with ANVISA unless the company responsible for manufacturing, importing, or distributing it holds valid company-level authorizations. This step comes before any product-level work — and it is the one most foreign companies underestimate.

Operating License (Licença de Funcionamento)

The Operating License is issued by the Local Health Surveillance authority (Vigilância Sanitária) in the municipality where the company is headquartered or where its warehouse or distribution facility is located. It confirms that the physical premises meet the health and sanitary standards required by the Ministry of Health. For imported cosmetics, the address on this license is typically that of the local importer or distribution partner — not the foreign manufacturer’s headquarters.

Company Operating Authorization — AFE (Autorização de Funcionamento Empresa)

The AFE is issued directly by ANVISA and operates at the federal level. It certifies that the company complies with all technical and administrative requirements set out in RDC 16/2014. The AFE number must appear on every product label the company distributes in Brazil — this is a hard labelling requirement, not optional. ANVISA only grants the AFE after verifying that the company meets Good Manufacturing Practices standards.

Good Cosmetic Manufacturing Practices (BPFCos)

Good Manufacturing Practices for Cosmetics (Boas Práticas de Fabricação de Cosméticos) establish the quality standards applied to all areas of production, storage, and distribution. Once a company’s operations are audited and found compliant, ANVISA issues a GMP Certificate confirming adherence to Standard Operating Procedures. For foreign manufacturers, ANVISA may accept equivalent certifications issued by regulatory bodies in the country of origin — but this requires case-by-case verification and local legal representation.

Foreign companies without a Brazilian legal entity cannot hold these authorizations directly. In practice, this means working through a local representative — either a Brazilian distributor, a subsidiary, or an Importer of Record who holds the regulatory authorizations on the foreign company’s behalf.

Step 2: Product Classification — Grade I vs Grade II

ANVISA classifies all cosmetics, personal hygiene products, and perfumes into two risk grades under RDC 949/2024 — the current regulatory framework that updated the earlier RDC 7/2015. The grade determines the entire registration pathway: what documentation is required, how long the process takes, and what ongoing compliance obligations apply.

Both grades cover products intended for external use on skin, hair, nails, lips, teeth, and mucous membranes of the mouth — used for cleaning, perfuming, altering appearance, neutralizing odors, or protecting skin integrity. The distinction lies in what each product claims to do and how much evidence is needed to support those claims.

Feature	Grade I	Grade II
Risk level	Lower	Higher
Authorization type	Notification (prior communication)	Full registration with dossier
Stability studies required	No	Yes (preliminary, accelerated, shelf life)
Proof of efficacy required	No	Yes
Examples	Perfumes, nail polish, basic moisturizers (no sunscreen)	Sunscreens, anti-dandruff shampoos, hair straighteners, insect repellents, children’s products
Validity	5 years from notification date	10 years from DOU publication
Regulatory basis	RDC 949/2024 + RDC 907/2024	RDC 949/2024 + RDC 907/2024

The classification also determines labelling obligations. Grade II products require more extensive warnings, usage restrictions, and contraindications on packaging — and some categories, such as sunscreens and children’s products, require specific labelling elements that go beyond the standard requirements for Grade I products.

Step 3: Notification vs Registration

Notification (Grade I Products)

For Grade I products, ANVISA does not require pre-market approval in the traditional sense. The company submits a prior notification — a formal declaration to the General Management of Cosmetics (GGCOS) informing ANVISA of its intention to commercialize the product. Products not listed in Annex VIII of RDC 07/2015 are exempt from registration entirely, though they still require the company to hold an AFE and Operating License.

Notifications are valid for five years. The process is electronic and handled through ANVISA’s digital platforms, but it requires accurate product data, labelling compliance, and a company in good regulatory standing. Even the simpler notification pathway carries real administrative weight for companies unfamiliar with Brazilian systems.

Registration (Grade II Products)

Grade II products require formal registration before they can be imported or sold. Under RDC 907/2024, nine specific product categories are subject to the full registration process: suntan and sunscreen products, antiseptic hand gels, hair straightening and coloring products, hair waving products, and insect repellents for adults and children. The registration dossier must include stability studies demonstrating the product remains safe and effective throughout its shelf life.

ANVISA requires three types of stability data for Grade II products. Preliminary stability studies test the formulation under stress conditions to screen for instability early in development. Accelerated stability studies verify compatibility between product and packaging and propose a shelf life. Real-time (shelf life) studies run under normal storage conditions throughout the validity period, confirming the estimates made at the accelerated stage.

Once approved, registration is valid for 10 years from the date of publication in Brazil’s Official Federal Gazette (Diário Oficial da União — DOU). Renewal must be initiated in the final six months of the registration period. ANVISA may require additional evidence or tests at any point during the registration lifecycle.

Since 2025, ANVISA has also introduced stricter post-market surveillance requirements through RDC 894/2024, which mandates a Cosmetovigilance system for all companies. Serious adverse events must be reported and documented, with records retained for five years and available to authorities on request.

Step 4: Labelling Requirements for Brazil

ANVISA’s labelling requirements under RDC 907/2024 apply to all cosmetics, regardless of grade. All labels must be in Portuguese, legible, and truthful — any therapeutic claims, disinfectant properties, or insect protection claims (unless the product is registered for that purpose) are prohibited. Labels must not mislead the consumer about the product’s nature, composition, or effects.

Primary Packaging

Primary packaging — the container in direct contact with the product — must display the product name and group or type (if not implied in the name), the brand, lot number, instructions for use if applicable, warnings and usage restrictions, and any specific labelling required for that product category.

Secondary Packaging

Secondary packaging — the outer box or container — must include everything on the primary label plus the product registration or notification number, expiration date, contents, country of origin, manufacturer or importer name and address, usage mode (if applicable), ingredients or composition, and specific warnings. When there is no secondary packaging, all of this information must appear on the primary packaging itself.

For small primary packaging where space is limited, warnings may appear in an attached leaflet — but the primary packaging must carry a visible reference: “Ver folheto anexo” (See attached leaflet). The AFE number of the Brazilian importer or manufacturer must appear on all labels; this alone requires a local authorized entity.

Category-Specific Warning Requirements

Beyond the standard requirements, ANVISA mandates additional warnings for specific product categories. Aerosols must carry flammability warnings and instructions to keep away from heat and children. Hair relaxers and neutralizers must warn against use on irritated or damaged scalp. Hair dyes and lightening agents carry their own set of mandatory warnings. Each product category has a specific checklist — a thorough review of the applicable ANVISA resolutions is necessary before finalizing packaging for Brazil.

Step 5: The Import Process with ANVISA

Once company and product authorizations are in order, importing cosmetics requires a specific process through ANVISA’s specialized surveillance posts. The analysis is entirely electronic, conducted through the Portal Único Siscomex — the Brazilian government’s foreign trade control platform.

ANVISA’s Specialized Posts and PAFCO

ANVISA processes import petitions through four distinct health surveillance posts, each responsible for a different product category. Cosmetics, personal hygiene products, and perfumes are handled by PAFCO — the Health Surveillance Post for Ports, Airports, Borders, and Customs Enclosures in Cosmetics, Sanitizing, Hygiene and Others. Regardless of which physical port or airport the shipment enters through, PAFCO handles the analysis electronically. The import process runs through both DataVisa (ANVISA’s internal system) and Siscomex Importação Web, which requires careful document submission to allow ANVISA inspectors to work across both platforms.

Electronic Import Petition (PEI) — Required Documents

The importer or their legal representative submits an Electronic Import Petition (PEI) via the Portal Único Siscomex. The following documents must be attached:

• Petition for Inspection and Sanitary Release, as specified in sub-item 1.2 of Chapter II of RDC 81/2008
• Extract of Import License (LI) — not legally mandatory, but ANVISA’s own guidance recommends its annexation to accelerate analysis
• Commercial Invoice (original, signed copy)
• Bill of Lading (original, signed copy)
• Declaration of the Registration Holder (DDR), required when the importer is not the holder of the product’s ANVISA regularization

After the License to Import (LI) is analyzed, ANVISA may raise technical requirements — requests for additional information or documents. The deadline to comply with any requirement is 30 days from the date it is registered in Siscomex; this deadline is non-extendable. Once ANVISA grants authorization, the import can proceed through normal customs clearance.

For a detailed guide on Brazil’s general import customs procedures, see Customs Clearance Process Brazil.

Working Without a Local Entity: The IOR Solution

For foreign cosmetics companies that want to test the Brazilian market before committing to a local subsidiary, the Importer of Record (IOR) model offers a practical path. An IOR is a Brazilian legal entity that holds the ANVISA authorizations — AFE, Operating License, GMP Certificate — and acts as the registered importer on all import documentation. The foreign company retains commercial control of its products while the IOR handles regulatory compliance, import clearance, and Siscomex submissions.

This structure is particularly relevant for cosmetics because ANVISA requires all labels to carry the AFE number of the Brazilian company responsible for the product. Without a local entity, this requirement cannot be met. The IOR model resolves this without requiring the foreign brand to establish a subsidiary, register as a Brazilian company, or hire local staff.

Novatrade’s Importer of Record and regulatory compliance services are designed for exactly this scenario — handling ANVISA authorizations, import petitions, and ongoing compliance management for international cosmetics and health product brands entering Brazil. Contact our team to discuss your product’s regulatory pathway.

Frequently Asked Questions

Can a foreign company register cosmetics with ANVISA directly?

No. ANVISA requires that the company holding a cosmetic product’s registration or notification be a Brazilian legal entity, holding a valid AFE (Autorização de Funcionamento Empresa) and Operating License. Foreign companies must work through a local Brazilian partner — either a subsidiary, a distributor, or an Importer of Record (IOR) — who holds these authorizations on their behalf.

What is the difference between Grade I and Grade II cosmetics in Brazil?

Under RDC 949/2024, Grade I cosmetics (such as perfumes, nail polish, and basic moisturizers) require only prior notification to ANVISA and carry lower documentation requirements. Grade II products — including sunscreens, hair straighteners, anti-dandruff shampoos, and insect repellents — require full registration with a complete dossier that includes stability studies proving safety and efficacy. Grade II registrations are valid for 10 years; Grade I notifications are valid for 5 years.

How long does ANVISA cosmetics registration take in Brazil?

Timelines vary significantly by product grade and document completeness. Grade I notifications, when all documentation is in order, can be processed within weeks. Grade II registration — which requires a full dossier, stability studies, and ANVISA review — typically takes several months. Incomplete petitions or technical requirements raised by ANVISA (which allow 30 days to respond, non-extendable) are the most common cause of delays.

What is PAFCO and how does it affect my cosmetics import?

PAFCO is ANVISA’s specialized health surveillance post for cosmetics, personal hygiene products, sanitizers, and perfumes. All import petitions for these product categories — regardless of the physical port of entry — are analyzed electronically by PAFCO through the Portal Único Siscomex. PAFCO reviews the Import License (LI) and attached documentation, and may raise technical requirements before authorizing the import. ANVISA authorization from PAFCO is a prerequisite for customs clearance.

What labelling changes are required for cosmetics sold in Brazil?

All cosmetic labels for the Brazilian market must be in Portuguese and comply with RDC 907/2024. Required information includes the product name, brand, AFE number, lot, expiry date, country of origin, importer or manufacturer details, ingredients, and any applicable warnings for the product category. Labels cannot include therapeutic claims, disinfectant properties, or insect protection references unless the product is specifically registered for those purposes. Foreign packaging must be adapted — partial translation via a sticker is generally accepted, but the AFE number of the Brazilian importer is non-negotiable.

What is Cosmetovigilance and does it apply to imported products?

Yes. Under RDC 894/2024 (in force since 2025), all companies placing cosmetics on the Brazilian market — including importers — must have a Cosmetovigilance system in place. This system tracks adverse events related to product use. Serious adverse events must be formally reported to ANVISA, documented, and records retained for five years. The Cosmetovigilance obligation applies to the Brazilian entity responsible for the product (distributor, subsidiary, or IOR).

Conclusion

ANVISA’s regulatory framework for cosmetics is thorough by design. Brazil’s cosmetics market is worth more than US$22 billion annually, and the regulatory barriers exist to protect consumers in proportion to that scale. For foreign companies, the path to compliance runs through five distinct stages: company authorization, product risk classification under RDC 949/2024, notification or registration, labelling compliance with RDC 907/2024, and electronic import clearance through PAFCO.

The critical constraint for international brands is the local entity requirement. ANVISA authorizations — AFE, Operating License, and product registrations — must be held by a Brazilian legal entity. Companies that want to enter the market without establishing a subsidiary can do so through an Importer of Record, which handles compliance, holds the authorizations, and manages the import process on the foreign company’s behalf. This model is how many European cosmetics brands first establish a commercial footprint in Brazil before committing to a local structure.

For a broader view of Brazil’s health regulatory landscape, the article on Brazil’s health regulatory agencies maps the full institutional picture — ANVISA alongside INMETRO, ANATEL, and other authorities that may be relevant depending on your product portfolio. If you are also assessing the temporary import route for trade fair demonstrations before committing to full commercialization, see Temporary Admission of Health and Cosmetics Products as an Import Strategy.

Ready to move forward? Contact Novatrade’s regulatory team to assess your products’ classification, map the documentation requirements, and define a compliance timeline for your Brazil entry.