How to regulate hair care products?

ANVISA classifies cosmetic products into two categories for regularization purposes:

1. Grade 1 products: These are products that have basic properties and do not require proof of efficacy. Commonly used shampoos, conditioners and hair masks, for example, generally fall into this category. They only require notification to ANVISA, a simplified process.
2. Grade 2 products: These are products that have specific indications or actions that need to be proven, such as anti-hair loss, anti-dandruff or intensive treatment products. For this category, it is necessary to register with ANVISA, a more detailed process that includes the presentation of efficacy and safety studies.

The process of regularizing hair care products with ANVISA involves several stages, which must be followed carefully to ensure compliance. See step by step:

1. Define the Product Category: Determine whether the product is Grade 1 or Grade 2, as this will determine the type of regularization process (notification or registration).
2. Documentation Required: Gather all the documentation required by ANVISA, which may include:
   1. Application Form: Document that formalizes the request to ANVISA.
   2. Safety and efficacy studies: For Grade 2 products, it is necessary to submit studies proving the efficacy and safety of the product, among others.
3. Company registration with ANVISA: The company responsible for the product must be duly registered with ANVISA and have an Operating Authorization (AFE) for the cosmetics segment.
4. Submitting the Notification or Registration:
   1. Notification: For Grade 1 products, simply send the documentation through ANVISA's electronic system, the Product Registration Automation System. Once submitted, the product can be marketed.
   2. Registration: For Grade 2 products, it is necessary to submit a complete dossier, which will be analyzed by ANVISA. The product can only be marketed after approval and publication in the Federal Official Gazette (DOU).
5. Payment of fees: It is necessary to pay the Sanitary Inspection Fees (TFS) corresponding to the type of regularization requested.
6. Monitoring the process: After submission, monitor the progress of the notification or registration process.

• Consult Regulatory Affairs Specialists: Specialized companies, such as Stone Okamont, can help with the entire regularization process, ensuring agility and compliance with ANVISA standards.
• Keep up to date with ANVISA regulations: Cosmetics regulations can change from time to time. It is essential to keep up to date to avoid non-compliance.
• Invest in Quality Documentation: Clear, complete and well-organized documentation can speed up the approval process and avoid additional requirements from ANVISA.

Stone Okamont is a consultancy specializing in regulatory affairs and is ready to help your company regularize cosmetic products with ANVISA. With a team of experts, we offer customized solutions, agility in the notification and registration process, and complete support so that your products are always in compliance with legal requirements. Contact us and find out how we can make the process of regularizing your hair care products easier!