Overview
The regularization of cosmetics in Brazil goes through specific processes defined by Anvisa. With the entry into force of RDC 752/2022, the procedures have become clearer and more digital, but still require attention to detail. This updated guide for 2025 presents a step-by-step process for registration (or notification), explains the risk categories and provides essential tips for avoiding rework.
Introduction
Brazil is one of the largest cosmetics markets in the world, but in order to put a product on the shelves, it has to be regulated by Anvisa. This process varies according to the product’s risk category (grade 1 or grade 2) and requires the presentation of technical documents, correct labeling and proof of safety.
With the regulatory update promoted by RDC 752/2022, the process has been digitized and modernized, but doubts about the flow, deadlines and specific requirements are still common
Grade 1 x Grade 2: what's the Difference
Before registering or notifying a cosmetic, it is essential to know which category the product falls into:
- Grade 1: Products with minimal risk to the user and generic claims (e.g. common soaps, basic shampoos). They do not require prior approval, only notification.
- Grade 2: Products with potential risk (e.g. children’s products, whitening products, anti-dandruff products, intimate use products) and/or which make functional claims. They require prior regularization (registration).
Step by step to regularize a cosmetic with Anvisa:
- Classify the product
- Check whether the cosmetic is grade 1 or grade 2 based on composition, intended use and label claims.
- Register the company with Anvisa The company must have
- Authorization to Operate (AFE) or exemption
- Registration in the Request and Electronic Petitioning System
- Technical manager (pharmacist or qualified professional).
- Gather the technical documentation Application form (generated by the Anvisa system)
- Qualitative and quantitative composition;
- Function of each ingredient;
- Safety dossier (for grade 2);
- Labeling information;
- Reports (microbiological, stability, safety) – when applicable.
- Apply to the Anvisa system:
- Grade 1: Notification application → automatic release.
- Grade 2: Application for registration → technical analysis with an average time limit of 120 days (this may vary).
- Follow the process and keep up to date
In the case of registrations, follow the progress through the system. For notified products, keep the documentation up to date and available for inspection
What is the average time to release a cosmetic
Tipo de produto | Processo | Tempo estimado |
Grau 1 | Notificação | Liberação instantânea após petição |
Grau 2 | Registro | Cerca de 120 dias corridos* |
* Pode variar conforme a qualidade da documentação e fila de análise da Anvisa.
Common Mistakes in the Process
With the publication of the Good Cosmetic Surveillance Practices Inspection Manual and the Questions and Answers document on RDC 894/2024, ANVISA has taken another important step towards strengthening the safety of cosmetic products in Brazil. The new rules demand greater responsibility from companies, but also guarantee more protection for consumers, ensuring that the sector continues to grow in a safe and reliable manner. Adapting to these new guidelines is essential for the Brazilian cosmetics industry to remain competitive in the global market, while ensuring the health and well-being of its consumers.
Common Mistakes in the Process
Avoid these mistakes that can delay or prevent the product from being regularized:
❗️ Incorrect choice of product grade
❗️ Lack of proof of safety (especially for grade 2)
❗️ Ingredients not permitted by Anvisa
❗️ Labeling not up to mandatory standards
❗️ Divergent information between label and technical composition
❗️ Lack of AFE or irregular company registration
Conclusion
Regulating a cosmetic with Anvisa in 2025 is a well-structured process, but one that requires technical attention and regulatory knowledge. The good news is that, with proper planning and documentation, notification or registration can be done efficiently – especially with the use of the agency’s digital tools.
Regulatory professionals and companies that master these steps gain agility when launching new products and ensure legal and commercial compliance.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.