Cosmetics

Understand Cosmetic Regulations in Brazil with Freyr - Overview

Brazil is a relevant market for cosmetic products in Latin America, supported by a well-established regulatory framework aimed at ensuring the safety, quality, and regulatory compliance of products throughout their lifecycle. Companies planning to commercialize cosmetic products in Brazil must understand the local regulatory requirements, classification criteria, and ongoing compliance obligations to ensure sustainable market access.

Having a clear regulatory strategy is essential to navigate the Brazilian regulatory environment and to avoid delays, rejections, or compliance risks, particularly during post-marketing stages.

Health Authority and Legal Framework for Cosmetics in Brazil

In Brazil, cosmetic products are defined as products intended to cleanse, protect, and beautify different parts of the body. Cosmetics are characterized by external and non-invasive use, meaning they are designed for external application and do not penetrate deep layers of the skin. Their purpose is aesthetic, intended to cleanse, perfume, modify appearance, protect, or maintaining in good condition, the body parts to which they are applied.

Cosmetic products are regulated by ANVISA, as the national health authority which regulates the production, import, and trade of Cosmetics.

The regulatory framework applicable to cosmetic products in Brazil is based on pre-marketing and post-marketing control mechanisms, aimed at ensuring that products comply with applicable regulations and do not pose risks to consumer health.

Cosmetic Product Classification in Brazil

What You Need to Know

In Brazil, the proper classification of cosmetic products is a key factor in determining the regulatory requirements applicable throughout their lifecycle. Product classification directly impacts regulatory obligations, labeling requirements, permitted formulations, and regulatory control mechanisms.

Compliance with the requirements established by ANVISA regarding safety, formulation, labeling, and technical documentation is mandatory both for market entry and for the ongoing commercialization of cosmetic products in Brazil.

The classification of cosmetic products in Brazil is categorized into Grade I and Grade II, depending on the level of risk. According to ANVISA Cosmetic regulations, there are two (2) primary authorization pathways. The key differences between Grade 1 and Grade 2 Cosmetics, based on the provided definitions, are as follows:

Grade I Products

• Require prior notification to Anvisa before commercialization;
• Subject to a lower level of initial health surveillance;
• Generally, present a lower risk profile, as they are characterized by basic or essential functional properties.

Grade II Products

• Require prior registration with Anvisa, subject to technical review and favorable decision by the Agency before commercialization;
• Subject to a higher level of health surveillance;
• Have specific intended uses whose characteristics require demonstration of safety and/or efficacy, as well as clear information regarding precautions, directions for use, and any applicable restrictions.

Sanitary Control Framework and Notice of Operation for Cosmetic Products

In Brazil, cosmetic products are subject to a regulatory sanitary control framework supervised by ANVISA.

Although Grade I cosmetic products do not require prior registration before commercialization, the company must obtain an Operating License (also known as Alvará Sanitário) from the competent local health authority (state or municipal level). In addition, compliance with Anvisa’s requirements regarding safety, formulation, labeling, and technical documentation is mandatory for both market entry and continued commercialization, and products are subject to post-marketing surveillance and sanitary control mechanisms.

Once the Operating License has been obtained, the company must proceed with its regularization before the Brazilian Health Regulatory Agency (Anvisa) and apply for the AFE (Autorização de Funcionamento de Empresa - Company Operating Authorization).

The AFE is a mandatory federal authorization granted by Anvisa to legal entities intending to conduct activities involving products subject to sanitary control, such as cosmetics. It authorizes the company to carry out regulated activities including manufacturing, importing, distributing, storing, or other applicable operations.

Local Representation Requirement for Cosmetic Products in Brazil

Foreign companies without a legal presence in Brazil must designate a local legal entity to act as their regulatory liaison with the competent authorities.

This local representative is responsible for managing regulatory filings, maintaining communication with the health authority, and ensuring ongoing compliance with post-marketing regulatory obligations associated with cosmetic products in Brazil.

Cosmetovigilance

Manufacturers and importers of cosmetic products are responsible for placing safe and effective products on the market, whose use must not cause harm to consumers under normal and reasonably foreseeable conditions of use.

Accordingly, a cosmetovigilance system must be established within each company in order to:

• Receive and document information or complaints related to problems arising from product use, quality defects, counterfeiting, or undesirable effects.
• Evaluate each complaint or piece of information received by the company and investigate occurrences according to the severity and risk of each situation.
• Maintain an updated and properly documented file for each report to ensure traceability of information related to the cosmetovigilance actions carried out by the company.
• Maintain technical procedures to guide cosmetovigilance activities, from receipt and handling to analysis and conclusions.
• Notify the federal health authority when the evaluation of reports identifies situations that may pose a risk to the user’s health.

Therefore, the company must have a cosmetovigilance system in place, and all cosmetovigilance activities must be overseen by a local person responsible for cosmetovigilance, duly appointed in accordance with ANVISA requirements.