Brazil is one of the world’s largest beauty and personal care markets. ABIHPEC reports that the sector represents about 2% of Brazil’s GDP and that Brazil is currently the third-largest consumer market globally.
Brazil regulates personal hygiene products, cosmetics and fragrances through ANVISA. RDC 907/2024 is one of the main current rules covering how these products are classified, labeled and regularized before sale.
Cosmetic products in Brazil may follow either a registration route or a notification route, depending on the product category and level of risk. Only specific higher-risk products require registration with ANVISA, while other cosmetics are generally exempt from registration and are regularized through notification.
Cosmetic Regulatory Authority in Brazil
ANVISA is the main federal health authority responsible for the regulation of personal hygiene products, cosmetics and fragrances in Brazil. Within ANVISA, the General Management of Cosmetics and Sanitizing Products (GGCOS) handles regulatory matters related to these product categories.
Brazil also aligns many cosmetic requirements with Mercosur rules, but those requirements apply in Brazil only after they are incorporated into Brazilian regulation.
Classification of Cosmetics in Brazil
ANVISA classifies personal hygiene products, cosmetics and fragrances into Grade 1 and Grade 2 based on the level of risk and the type of claims made for the product.
Grade 1 products have basic or elementary properties and generally do not require detailed proof of safety or efficacy for their intended use.
Examples may include:
- basic moisturizers
- shampoos and conditioners
- perfumes
- lipsticks
- nail products
- makeup products without specific higher-risk claims
Grade 2 products have specific indications or characteristics that require proof of safety and/or efficacy, along with more detailed instructions or restrictions for use.
Examples may include:
- sunscreens
- children’s products
- hair straightening or curling products
- products with anti-wrinkle claims
- insect repellents
- antiseptic products
ANVISA Cosmetic Registration vs Notification in Brazil
Brazil uses two main regularization routes for personal hygiene products, cosmetics and fragrances: registration and notification.
Products that fall into specific higher-risk categories must be registered with ANVISA before they can be marketed. Other cosmetic products are generally exempt from registration and follow the notification route instead.
Products that require registration include categories such as:
- tanning products
- antiseptic hand gel
- hair straightening products
- products that straighten and dye hair
- hair-waving products
- sunscreens
- children’s sunscreens
- insect repellents
- children’s insect repellents
Other cosmetics, such as many shampoos, soaps, deodorants, perfumes and similar products, generally follow the notification route if they do not fall into a category that requires registration.
Company Requirements and AFE for Cosmetics in Brazil
Before submitting a cosmetic registration or notification in Brazil, the responsible Brazilian company must be properly regularized with ANVISA.
For activities such as manufacturing, importing, distributing, storing or transporting personal hygiene products, cosmetics and fragrances, companies generally need an Autorização de Funcionamento de Empresa (AFE). Retail sale of cosmetics is generally exempt from the AFE requirement.
For cosmetic product registration, ANVISA specifically states that companies manufacturing or importing cosmetics must have an AFE before submitting the product application.
Foreign manufacturers need a legally established Brazilian company to act as the responsible party for product regularization in Brazil.
ANVISA Cosmetic Registration Process in Brazil
For cosmetic products that require registration, the responsible company must first complete the necessary company regularization with ANVISA.
The process generally involves:
- Company registration in ANVISA systems
- Adjustment of company size, where applicable, because this can affect the applicable fees
- Obtaining the required Company Operating Authorization (AFE) for activities such as manufacturing or importing cosmetics
- Preparing the product registration application and supporting documents
- Submitting the application through ANVISA’s Solicita system
- Paying the applicable Health Surveillance Inspection Fee (TFVS) through the generated payment document
- Monitoring the application through Solicita or the ANVISA Consultation Portal
- Responding to any requests for additional information during ANVISA’s review
- Waiting for the final decision and publication of the registration in the Official Gazette (DOU)
ANVISA carries out a prior technical review for products that require registration. If the application meets the applicable technical and regulatory requirements, the registration is granted and published in the DOU. The product can then be marketed throughout Brazil.
The registration is valid for 10 years and may be renewed.
ANVISA Notification Process for Cosmetics Exempt from Registration
Products that are exempt from registration follow a simplified notification process rather than full prior technical review.
Since April 7, 2025, new notifications and changes for exempt cosmetic products must be submitted through Solicita/Datavisa. The older SGAS system is no longer used for these requests.
The notification process generally involves:
- Registering and regularizing the responsible company with ANVISA
- Obtaining the required AFE for activities such as manufacturing or importing cosmetics
- Confirming that the product is not one of the categories that requires registration
- Selecting the appropriate notification subject code in Solicita
- Submitting the required product and company information
- Paying the applicable fee, where required
- Completing the electronic notification process and keeping the supporting documentation available for regulatory inspection
ANVISA does not carry out the same prior technical assessment for notified products that it performs for registered higher-risk products. The company remains responsible for ensuring that the product complies with all applicable technical, safety and labeling requirements.
The current Solicita/Datavisa notification system also uses specific subject codes—for example, code 2726. ANVISA also uses separate subject codes for migration, cancellation, continuation of commercialization and alteration of notified products.
ANVISA Registration Timeline and Validity for Cosmetics
For cosmetic products that require registration, ANVISA states that the registration is valid for 10 years from the date it is published in the Official Gazette (DOU). The registration can be renewed if the company wants to continue marketing the product.
For cosmetics that are exempt from registration and follow the notification route, the prior communication is also valid for 10 years. If the company wants to continue marketing the product after that period, it must declare its interest in continuation within the last six months before expiry.
Cosmetic Labeling Requirements in Brazil
Cosmetic labels in Brazil must comply with RDC 907/2024 and other applicable labeling requirements, including RDC 898/2024 for ingredient composition in Portuguese.
The label should provide the information required for the correct identification and safe use of the product. It must not contain names, claims, images or other statements that could mislead consumers about the product’s composition, properties, origin or intended use.
Ingredient information must continue to follow INCI nomenclature. ANVISA also requires the ingredient composition to be available in Portuguese. Under RDC 898/2024, the Portuguese composition can be shown directly on the label or provided digitally through a code that takes the user directly to the ingredient information for that specific product.
Additional warnings or statements may also be required depending on the product category and its intended use.
Importation of Cosmetics in Brazil
Cosmetics imported for commercial sale in Brazil must comply with ANVISA’s sanitary import controls in addition to the product regularization requirements that apply to the cosmetic itself.
The Brazilian importer generally needs the appropriate ANVISA authorization for import activities. ANVISA’s AFE rules specifically require authorization where a company carries out regulated import activities involving products such as cosmetics, personal hygiene products and fragrances.
Brazil is also moving to the new DUIMP import model. From April 27, 2026, imports of products subject to sanitary surveillance by air and sea must be registered through DUIMP, replacing the previous LI/DI model for these operations. ANVISA’s sanitary review is integrated into the Single Foreign Trade Portal.
For imported cosmetics, companies should therefore make sure that:
- the Brazilian importer is properly authorized for the relevant activity
- the cosmetic product itself is properly registered or notified with ANVISA, as applicable
- the import declaration contains the required ANVISA information
- the shipment complies with the sanitary requirements applicable at customs clearance
Children’s Cosmetics in Brazil
Most children’s personal hygiene products, cosmetics and fragrances are exempt from registration with ANVISA and follow the notification route.
However, children’s sunscreens and children’s insect repellents still require registration because they fall into the higher-risk product categories listed by ANVISA.
Even when a children’s cosmetic is exempt from registration, the manufacturer remains responsible for meeting the applicable technical, safety and labeling requirements. ANVISA also requires safety to be demonstrated for children’s cosmetic categories.
Animal Testing for Cosmetics in Brazil
Brazil now prohibits the use of live vertebrate animals for testing personal hygiene products, cosmetics, perfumes and ingredients intended exclusively for these products. The law excludes formulations and ingredients intended to repel insects from this definition. The prohibition was introduced by Law No. 15,183 of July 30, 2025.
The law also states that new animal-test data generated after the law took effect cannot generally be used to support the marketing of cosmetics or their ingredients, except where the testing was carried out to meet a non-cosmetic regulatory requirement. Products and ingredients tested on animals before the law took effect may still be marketed.
Internationally recognized and validated alternative testing methods are to be accepted on a priority basis by Brazilian authorities.
Conclusion
Brazil has a two-route system for cosmetics: some higher-risk products require registration with ANVISA, while many other products follow the notification route.
The exact requirements depend on the product category, the company’s activities in Brazil, and whether the product is manufactured locally or imported. Companies also need to meet the applicable labeling, safety, technical and post-market requirements.
Keeping the company authorization, product classification, registration or notification route, and current ANVISA requirements aligned can help avoid delays during market entry.
Artixio can support companies with ANVISA cosmetic registration, notification, labeling and other regulatory requirements in Brazil. Learn more about our Brazil regulatory services.
FAQs
1. Does every cosmetic product need ANVISA registration in Brazil?
No. Only specific higher-risk cosmetic categories require registration with ANVISA. Many other personal hygiene products, cosmetics and fragrances are exempt from registration and follow the notification route instead.
2. What is the difference between ANVISA registration and notification for cosmetics?
Registration involves prior ANVISA review for specific higher-risk product categories before they can be marketed. Notification is a simpler regularization route used for products that are exempt from registration.
3. Which cosmetic products require ANVISA registration?
Products that require registration include categories such as sunscreens, children’s sunscreens, insect repellents, children’s insect repellents, hair-straightening products, certain hair-waving products, tanning products and antiseptic hand gel.
4. What is the difference between Grade 1 and Grade 2 cosmetics in Brazil?
Grade 1 products have basic or elementary properties and generally have lower sanitary risk. Grade 2 products have specific indications or characteristics that require more detailed safety or efficacy information and additional labeling precautions.
Grade 2 classification does not automatically mean that the product requires registration.
5. Can a foreign company register cosmetics directly with ANVISA?
A foreign manufacturer generally needs a legally established Brazilian company to act as the responsible party for regulated activities in Brazil. The Brazilian company must have the appropriate authorizations for activities such as importing or manufacturing cosmetics.
6. How long is ANVISA cosmetic registration valid?
For cosmetic products that require registration, ANVISA registration is valid for 10 years and can be renewed.
Products following the notification route also have a 10-year regularization period, with continuation requirements before expiry.
7. Which system is used for cosmetic registration and notification in Brazil?
ANVISA uses the Solicita system for cosmetic registration applications. Since April 2025, notifications and related requests for cosmetics exempt from registration are also submitted through Solicita/Datavisa.
