ANVISA: Regulatory Requirements For Personal Hygiene Products, Cosmetics, And Perfumes In Brazil (2025)

Brazil is one of the largest and fastest growing global markets for cosmetics, perfumes, and personal care products. To ensure consumer safety and product quality, the Agência Nacional de Vigilância Sanitária (ANVISA) enforces a comprehensive regulatory framework.

The introduction of RDC 907/2024 marks a significant modernization of Brazil’s cosmetics regulations, effective in 2025. These updates aim to:

• Simplify compliance pathways 
• Strengthen safety and transparency 
• Aligning with international and Mercosur standards 

For manufacturers and importers, understanding these requirements is essential for successful market entry and sustained compliance.

What are ANVISA’s 2025 requirements for cosmetics in Brazil?
ANVISA’s 2025 regulations require cosmetics, perfumes, and personal hygiene products to follow a risk-based classification (Grade 1 and Grade 2), comply with RDC 907/2024, meet strict labeling and safety requirements, and be submitted through a Brazilian local partner for notification or registration.

Regulatory Framework Overview

ANVISA regulates:

• Personal hygiene products 
• Cosmetics 
• Perfumes 

under a risk-based classification system, supported by digital submission processes and strict safety standards.

1. Product Classification (Risk-Based System)

Products are classified into two categories:

Grade 1 (Low Risk Products)

Characteristics:

• Basic functions 
• Minimal health risk 
• No specific claims 

Examples:

• Soaps 
• Shampoos 
• Basic creams 

Regulatory Requirement:

• Notification only (no prior approval) 

Products can be marketed immediately after notification.

Grade 2 (High Risk Products)

Characteristics:

• Specific or functional claims 
• Higher potential health risks 

Examples:

• Anti-dandruff products 
• Skin whitening products 
• Sunscreens 
• Children’s cosmetics 
• Intimate hygiene products 

Regulatory Requirement:

• Full registration and ANVISA approval required before commercialization 

These products undergo detailed safety and efficacy evaluation.

2. Notification vs Registration Process

Notification (Grade 1)

• Submission via ANVISA’s online system 
• Basic product information required 
• No prior technical review 

Fast and efficient pathway for low-risk products.

Registration (Grade 2)

• Comprehensive dossier submission 
• Includes: 
  • Safety data 
  • Efficacy evidence 
  • Technical documentation 
• Subject to ANVISA review and approval 

Required before product launch.

3. Labeling Requirements

Labeling is a critical compliance component.

Mandatory Information:

• Product name and function 
• Full ingredient list (INCI format) 
• Expiry date and batch number 
• Instructions for use 
• Warnings and precautions 
• Manufacturer/importer details 

Language Requirement:

• Must be in Portuguese 

Labels must be clear, accurate, and not misleading.

4. Safety and Microbiological Requirements

All products must meet strict safety standards before market entry.

Key Requirements:

• Toxicological safety assessments 
• Microbiological testing 
• Stability studies 
• Absence of harmful contaminants 

Ensures products are safe for consumer use under normal conditions.

5. Application Changes and Documentation Rules

Updated Rules (Effective June 2025):

• Changes allowed only before technical review begins 
• Incomplete submissions result in automatic rejection 

Emphasizes the importance of submission accuracy and completeness.

6. Local Representation Requirement

Foreign companies must appoint a Brazil-based legal entity.

Responsibilities of Local Partner:

• Product registration/notification 
• Regulatory compliance 
• Importation and distribution 
• Communication with ANVISA 

Direct submissions from foreign entities are not permitted.

7. Restricted and Prohibited Ingredients

ANVISA maintains updated lists of:

• Prohibited substances 
• Restricted ingredients 
• Allergen disclosures 

Alignment:

• Mercosur regulations 
• Global cosmetic safety standards 

Regular updates require continuous monitoring and reformulation readiness.

Recent Regulatory Updates (RDC 907/2024)

Key improvements introduced:

• Replacement of older fragmented regulations 
• Clearer classification criteria 
• Simplified submission pathways 
• Updated safety and ingredient lists 
• Defined transition timelines for compliance 

These updates enhance regulatory clarity and efficiency.

Compliance Workflow Overview

Key Challenges for Companies

Strategic Opportunities in Brazil

Action Steps for Compliance

To succeed in Brazil’s cosmetics market:

• Conduct accurate product classification 
• Ensure complete and validated documentation 
• Align formulations with restricted ingredient lists 
• Develop Portuguese-compliant labeling 
• Partner with a reliable local representative 
• Monitor ongoing regulatory updates 

Quick Facts

• ANVISA regulates cosmetics under RDC 907/2024 
• Products classified as Grade 1 or Grade 2 
• Portuguese labeling is mandatory 
• Local partner required for foreign companies 
• Digital submission system in place 

Why This Matters

Brazil’s updated framework reflects a shift toward transparent, risk-based, and globally aligned regulation.

Under the guidance of the Agência Nacional de Vigilância Sanitária, companies must demonstrate:

• Scientific and technical expertise 
• Regulatory accuracy 
• Product safety assurance 
• Operational compliance 

Strong regulatory execution builds consumer trust, brand credibility, and long-term market success.

How Maven Supports Cosmetics Compliance in Brazil

Our Services

• Product classification and regulatory strategy 
• ANVISA notification and registration support 
• Labeling and compliance review 
• Ingredient and formulation assessment 
• Local partner coordination 
• Post-market compliance management 

Why Choose Maven

• Expertise in ANVISA and global cosmetic regulations 
• End-to-end compliance support 
• Faster and accurate submissions 
• Market entry optimization 

Enter Brazil’s Cosmetics Market with Confidence

Planning to launch cosmetics or personal care products in Brazil?

Partner with Maven to:

• Ensure full regulatory compliance
• Avoid delays and rejections
• Accelerate market entry

Conclusion 

Brazil’s 2025 regulatory transformation under RDC 907/2024 represents a major step forward in modernizing cosmetic regulations.

The framework is built on three core pillars:

• Risk-based classification (Grade 1 vs Grade 2) 
• Digital-first submission processes 
• Enhanced safety and transparency requirements 

While these changes simplify certain pathways, especially for low-risk products, they also introduce stricter expectations for documentation, labeling, and safety validation.

For companies, success in Brazil now depends on:

• Getting classification right from the start 
• Submitting complete and accurate dossiers 
• Ensuring full compliance with ingredients and labeling rules 
• Building strong local partnerships 

Organizations that proactively align with these requirements will benefit from:

• Faster approvals
• Reduced compliance risks
• Stronger consumer trust
• Sustainable growth in a high-value market

Confidence & Compliance Perspective

Operating in Brazil’s regulated cosmetics market requires more than basic compliance it demands confidence in regulatory execution.

Companies must build systems that ensure:

• End-to-end documentation accuracy 
• Consistent regulatory monitoring 
• Rapid response to ingredients and safety updates 
• Clear accountability through local representation 

Confidence comes from:

• Robust internal compliance processes 
• Expert regulatory guidance 
• Continuous alignment with ANVISA updates 

In a market where regulatory enforcement is strict and evolving, confidence in compliance directly translates into business continuity and brand reputation.

FAQs

1. Who regulates cosmetics in Brazil?
The Agência Nacional de Vigilância Sanitária (ANVISA).

2. What is RDC 907/2024?
A regulation updating Brazil’s framework for cosmetics and personal care products.

3. What is the difference between Grade 1 and Grade 2 products?
Grade 1 are low-risk products requiring notification, while Grade 2 require full registration and approval.

4. Is Portuguese labeling mandatory?
Yes, all product labels must be in Portuguese.

5. Can foreign companies register products directly?
No, a Brazil-based local partner is required.

6. What happens if documents are missing?
The application is automatically rejected.

7. How can Maven help?
By providing end-to-end regulatory and compliance support for Brazil.