1. Certification Overview
In Brazil, cosmetics, hygiene products, and perfumes (HPPC) refer to any substance or mixture applied, either entirely or primarily, to the external surfaces of the human body (skin, hair, nails, lips, etc.) or to teeth and oral mucosa for the purpose of cleansing, deodorizing, altering appearance, protection, maintaining good condition, or correcting body odor.
As the premier licensing authority for cosmetics, ANVISA operates a dual approval system based on product risk levels. Low-risk Grade 1 products can enter the market immediately after registration via the online portal (SGAS), whereas high-risk Grade 2 products must undergo a rigorous technical review by ANVISA to obtain approval and receive a distribution certificate.
Grade 1: Soap, shampoo, hair mask, face mask
Grade 2: Children’s cosmetics, sunscreen, mosquito repellent
To export products to Brazil and proceed with ANVISA registration, overseas cosmetics manufacturers must designate an Authorized Notification Holder (ANH), a legally established local importer and agent. This agent goes beyond simple document processing; they hold the AFE (Authorized Feasibility Study) issued by ANVISA and assume full legal responsibility for product safety and local distribution.
2. Regulatory Agencies & Basic Information
| Regulatory Agencies | ANVISA (Agência Nacional de Vigilância Sanitária) |
| Testing Agency | 1) SGS Brazil 2) KTR Korea Brazil 3) Eurofins Brazil 4) Bioagri Laboratories (Mérieux NutriSciences) |
| Lead time | Grade 1: ~3 days Grade 2: 120 day goal |
| Price | Varies by product |
| Agent | A local agent in Brazil is required |
3. Registration Process
- Company Registration
- Product Classification
1) Grade 1: Basic products requiring immediate reporting (e.g., shampoo, lotion)
2) Class 2: Special products requiring ANVISA prior approval (e.g., sunscreens, hair straighteners, children’s products) - Document submission
- GMP certification
- Technology evaluation and approval
4. Required Documents
| • Brazilian Legal Representative • Company License • Product Information: 1) Detailed Ingredients: List of ingredients, concentrations, and content specified 2) Safety/Efficacy Data: Results of toxicological and microbiological tests and stability studies 3) Manufacturing Information: Compliance with Good Manufacturing Practice (GMP), plant information, and quality control procedures 4) Labeling and Packaging: Must be labeled in Portuguese in compliance with Brazilian regulations (RDC 752/2022) • Certification Differences: 1) Class 1 (Low Risk): Immediate import possible based on declaration 2) Class 2 (High Risk): Requires pre-market approval from the Australian Food and Drug Administration (ANVISA) • Common Issues: 1) Incomplete Documentation: May lead to delays, requests for additional information, or rejection 2) Non-Compliance with Labeling Regulations: Labels must be labeled in Portuguese, including specific information about the importer 3) Validity Period: Registration and declaration must be renewed every 5 years |
5. Validity Period
- Validity Period: 10 years