Overview
Before launching a cosmetic product in the Brazilian market, companies must identify whether it falls under Grade 1 or Grade 2 classification by Anvisa, Brazil’s health regulatory agency. This classification directly affects whether the product requires notification or full registration, which in turn impacts timelines, documentation, and compliance risks. In this Blog, we explain the difference between the two categories and how to ensure the correct classification to avoid costly rework.
Introduction
In Brazil, all cosmetic products must be regularized with Anvisa prior to commercialization. The type of process involved depends on the product’s risk grade — either Grade 1 (lower risk) or Grade 2 (higher risk). These categories are defined by RDC 752/2022, which considers the product’s intended use, application site, and claims.
Many businesses make mistakes in this initial step, which can lead to delays, reclassification demands, or even product recalls. Knowing the difference between the two categories helps ensure a smooth and compliant launch.
What Are Grade 1 and Grade 2 Cosmetics
🔹 Grade 1 – Low Risk
Products with basic claims and straightforward functions, which do not require proof of efficacy or safety beyond standard use. They are generally applied to less sensitive areas and are considered inherently safe.
Examples:
- Bar or liquid soaps
- Daily-use shampoos
- Basic body moisturizers
- Perfumes and colognes
Regulatory requirements:
- Electronic notification via Anvisa’s system (SGAS/Solicita)
- No technical dossier submission
- Immediate commercialization upon notification
- Minimal documentation
Quick and streamlined process
🔸 Grade 2 – Higher Risk
Products that make specific claims, are used in sensitive areas, or require evidence of safety and efficacy. These go beyond basic cosmetic effects and may influence skin physiology.
Examples:
- Sunscreens
- Antiperspirants
- Skin lightening products
- Anti-dandruff shampoos
- Baby cosmetics
Regulatory requirements:
- Mandatory registration with Anvisa
- Submission of technical dossier (with safety, efficacy, labeling, and clinical evidence if needed)
- Authorization must be granted before commercialization
- GMP certification may be required for manufacturers
More rigorous and documentation-heavy process
Common Mistakes and How to Avoid Them
- Classifying Grade 2 products as Grade 1 to speed up launch
- Overlooking the application site (e.g., intimate areas, around the eyes)
- Making therapeutic claims on Grade 1 cosmetics
- Missing documentation for products with active ingredients or for children
- Misclassification leading to penalties or market withdrawal
Conclusion
Understanding whether your cosmetic product is Grade 1 or Grade 2 is more than just a regulatory box to check — it guides your entire product registration strategy. A correct classification helps prevent delays, ensures compliance, and supports a faster market launch.
Always evaluate the intended use, formulation, application site, and claims before deciding on the regulatory pathway. When in doubt, seek professional guidance to avoid future complications.
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.