Regularization of Beauty Products with ANVISA

The regularization of beauty products involves the certification and authorization for the commercialization of cosmetics, perfumes, personal hygiene products, and other items aimed at aesthetic care. The objective is to ensure that these products meet the quality, efficacy, and safety standards established by ANVISA.

Regularization is essential for several reasons:

1. Consumer Safety: Products approved by ANVISA undergo rigorous testing and evaluation, ensuring they are safe for use.
2. Efficacy: Certification ensures that the products work as promised, providing the expected aesthetic or therapeutic benefits.
3. Consumer Confidence: Regularized products increase consumer confidence, resulting in a safer and more reliable market.
4. Legal Compliance: Companies that market products without regularization are subject to legal penalties, including fines and product seizures.

The regularization process at ANVISA involves several steps that must be rigorously followed:

1. Product Classification: First, it is necessary to classify the product according to the categories established by ANVISA, such as grade 1 (low risk) or grade 2 (high risk).
2. Documentation Submission: Companies must submit a series of documents, including efficacy and safety studies, technical reports, and manufacturing data.
3. Technical Evaluation: ANVISA's technical team evaluates the submitted documentation, which may include requests for additional information or the need for complementary tests.
4. Product Registration or Notification: Grade 1 products require only notification, while grade 2 products require registration. After approval at all stages, the product is authorized for commercialization. This registration must be renewed periodically.

The list of documents may vary depending on the type of product, but generally includes:

• Application Form: ANVISA standard document.
• Technical-Scientific Report: Includes efficacy and safety studies.
• Labels and Package Inserts: Must comply with current regulations.
• Manufacturing Data: Detailed information on the production process.
• Good Manufacturing Practices (GMP) Certificates: Issued by competent authorities.

1. Early Preparation: Start gathering the necessary documentation in advance.
2. Specialized Consultancy: Consider hiring Stone Okamont, a company specialized in regulatory consultancy, to assist in the process. Their expertise can facilitate navigation through ANVISA's complex requirements and ensure compliance with all necessary standards.
3. Continuous Update: Stay updated on changes in ANVISA’s norms and regulations.
4. Team Training: Ensure your team is well-trained in good manufacturing practices and regulatory compliance.

The regularization of beauty products with ANVISA is a detailed and demanding process but crucial to ensuring the safety and efficacy of products available on the market. Strictly following the steps of the process and staying updated on regulations can facilitate approval and prevent future problems.

For more information or to get help with the regularization of your beauty products, contact one of our consultants. We are here to help!