Regularization Processes for Cosmetic Manufacturers

The first step to regularizing a cosmetic product is to understand the legislation governing the sector. In Brazil, ANVISA is the main regulatory authority, and manufacturers must follow the guidelines established by the Collegiate Board Resolution (RDC), which defines the criteria for the safety, efficacy, and labeling of personal hygiene products, cosmetics, and perfumes. Additionally, other specific regulations may apply depending on the nature of the product.

Cosmetics notified are classified by ANVISA into two main categories based on the risk they pose to health:

• Grade 1: Products with basic properties that do not require proof of efficacy.
• Grade 2: Products with specific indications that require proof of safety and efficacy.

Registered products are established by ANVISA and require specific and rigorous analyses that vary according to the product. Understanding the classification of your product is crucial to determining the specific regularization requirements.

Depending on the classification of the cosmetic, the regularization process may involve registration or notification with ANVISA:

• Notification: Grade 1 or 2 products only need to be notified to ANVISA by filling out an electronic form with product information, noting that the dossier assembly is different.
• Registration: Products that must be registered involve a more detailed process, including the submission of a dossier with technical data and specific studies for each product to be notified.

Documentation is a fundamental part of the regularization process. The main required documents include:

• Filling out specific information about the product depending on its classification: Notification or Registration.
• Technical Dossier: Containing detailed information on formulation, specific analyses, quality control, and safety and efficacy studies.
• Labeling and Packaging: Must comply with ANVISA norms, including all mandatory information such as ingredients, usage instructions, precautions, and expiration date, among others.

For Grade 2 products, it is necessary to conduct safety and efficacy studies that prove the cosmetic is safe to use and effective for its intended purpose. These studies must be conducted by laboratories and follow the norms established by ANVISA. The results must be presented in the technical dossier during the registration or notification process.

Due to the complexity of the regularization process, many manufacturers opt to hire specialized consultancies like Stone Okamont. These consultancies offer comprehensive support in preparing the documentation, conducting the necessary studies, and navigating the bureaucratic process, significantly increasing the chances of quick and effective approval. Stone Okamont, for instance, stands out as a reliable partner for companies seeking to streamline the regularization of their cosmetic products and ensure compliance with all regulatory requirements.