Cosmetic Registration and Notification in Brazil
Bringing cosmetics to the Brazilian market requires compliance with Anvisa’s regulations. With Sobel as your partner, you simplify the process of cosmetic registration in Brazil, ensuring your dossier is complete, compliant, and ready for approval.
- Cosmetic manufacturers entering the Brazilian market.
- International companies importing cosmetic products into Brazil.
- Local brands preparing new product launches.
- Businesses needing support to meet Anvisa’s regulatory requirements.
Sobel helps you navigate cosmetic registration in Brazil with confidence, reducing risks and aligning your file to Anvisa’s requirements.
Why do you need this service?
Submitting a cosmetic product to Anvisa without expert guidance can lead to delays, resubmissions, or even rejection.
Our cosmetic registration Brazil service reduces these risks by checking your dossier against current requirements. From formula to labels, Sobel check every aspect of your file.
With a complete and structured dossier, your company saves time, avoids costly rework, and accelerates market entry.
Your journey to cosmetic approval with Anvisa
Sobel provides specialized guidance for both notification and registration, reviewing your documentation with precision and ensuring compliance with Anvisa’s standards.
Our support bridges the gap between your product development and Brazil’s regulatory framework, giving your company confidence at every stage.
We provide the official Anvisa checklist and align the scope of the required dossier.
Which regulatory pathway applies to your Cosmetic
Notification vs. Registration: Anvisa classifies cosmetics into different regulatory pathways depending on their risk level and intended use.
Notification (Class I – Low Risk)
Simplified process for low-risk products such as shampoos, conditioners, soaps, or body lotions.
Registration (Class II – Higher Risk)
Full evaluation required for products such as sunscreens, hair dyes, children’s cosmetics, and products with specific claims.
From simple notifications to full registrations, Sobel helps you identify the correct pathway and prepare all documentation according to Anvisa’s requirements.
Related
Services
Partner with Sobel to expand your compliance strategy in Brazil.
Our complementary services help you stay aligned with Anvisa while focusing on growth:
Anvisa Gap Analysis
Identify gaps in documents to improve compliance before registration or notification.
Supplier Audit & Qualification
Supplier audits and qualification support to help you meet GMP and certification requirements.
Brazilian Regulatory Representative
We act as your regulatory representative and manage Anvisa registration and notification.
Achieve cosmetic compliance in Brazil with Sobel’s expertise
Sobel’s specialists support your cosmetic registration in Brazil from start to finish: reviewing documentation, identifying non-conformities, and ensuring every requirement is met.
Let us help your brand minimize risks, save time, and enter the Brazilian market with confidence.
1. What is the difference between cosmetic notification and registration in Brazil?
Notification applies to Class I (low-risk) cosmetics and follows a simplified process, while registration is mandatory for Class II (higher-risk) products and requires a full dossier review.
2. How long does cosmetic registration in Brazil take?
Timelines vary depending on the type of product, the completeness of the dossier, and Anvisa’s workload at the time. Notification processes are generally faster than registrations, but each case is different. Sobel helps you prepare accurate and complete documentation to minimise delays and make the process as smooth as possible.
3. What documents are required for cosmetic registration?
The exact documentation depends on the product’s classification and specific characteristics. In general, Anvisa may require formula details, safety and stability data, labeling in Portuguese, packaging information, and technical justifications. Sobel can guide you to identify which documents apply to your case and ensure they are organized in the correct format for submission.
4. Can imported cosmetics be registered in Brazil?
Yes. Foreign companies can register or notify cosmetics in Brazil, but they must appoint a Brazilian Legal Representative to interact with Anvisa on their behalf. In addition, all documentation must be adapted to Brazilian standards, including labeling in Portuguese and technical data.
5. What happens if my cosmetic file is incomplete?
An incomplete dossier can lead to delays, additional requests from Anvisa, or even rejection of the process. This is why Sobel reviews your documentation in advance, identifying gaps and guiding corrections so your file is stronger and better prepared for submission.
