Brazil Cosmetic Regulation

Brazil is one of the largest and most dynamic cosmetic markets globally, attracting both domestic and international brands. To ensure consumer safety and product quality, cosmetic products placed on the Brazilian market shall comply with a comprehensive regulatory system overseen by the Brazilian Health Regulatory Agency (Anvisa). With clear rules spanning all stages of a product's lifecycle, the framework requires companies to thoroughly understand regulatory requirements to remain compliant in Brazil.

Part 1 Regulatory Framework and the Competent Authority

1.1 Main Regulations

In order to guarantee the safe use of cosmetics, Brazil has put in place an extensive system of regulations, covering key areas of cosmetics management, such as market authorization, labelling, quality control, ingredient oversight, and post-market surveillance.

1.2 Competent Authority

In Brazil, Anvisa serves as the primary authority responsible for governing the safety, quality, and regulatory compliance of cosmetic products. It also collaborates with governmental agencies, industry stakeholders, healthcare professionals, and international organizations to strengthen regulatory effectiveness and promote public health initiatives.

Part 2 Cosmetic Compliance Requirements

2.1 Definition

In Brazil, the term "cosmetic products" broadly includes personal hygiene products, cosmetics, and perfumes. These products are defined as preparations made from natural or synthetic substances intended for the external use on various parts of the human body—such as the skin, hair, nails, lips, and external genitals—as well as on the teeth and the mucous membranes of the oral cavity. Their exclusive or primary purpose is to cleanse, perfume, alter appearance, correct body odors, and/or protect or maintain these areas in good condition.

2.2 Classification

Resolution RDC No. 949/2024 sets out the current cosmetic classification in Brazil. Based on the product's formulation and intended purpose, the likelihood of adverse effects from improper use, etc., it categorizes products into Grade 1 and Grade 2.

2.3 Market Authorization

Before being placed on the Brazilian market, cosmetics shall be authorized by Anvisa through regularization, either by registration or notification. Resolution RDC No. 907/2024 establishes that nine specific groups of cosmetic products are subject to the registration process, including suntan products, antiseptic hand gels, hair straightening products, hair straightening and coloring products, hair waving products, as well as sunscreens and insect repellents for both adults and children. All other cosmetic products shall undergo notification to inform Anvisa of their intended commercialization.

2.4 Ingredients

Brazil monitors cosmetic ingredients through seven main regulations and their amendments, ensuring product safety and consumer protection. These regulations include:

1) Resolution RDC No. 529/2021: List of ingredients prohibited for use in cosmetic products

2) Resolution RDC No. 530/2021 and Resolution RDC No. 645/2022: Lists of ingredients restricted for use in cosmetic products

3) Resolution RDC No. 628/2022: List of colorants permitted for use in cosmetic products

4) Resolution RDC No. 528/2021: List of preservatives permitted for use in cosmetic products

5) Resolution RDC No. 600/2022: List of ultraviolet filters permitted for use in cosmetic products

6) Regulatory Instruction No. 220/2023: List of active ingredients permitted for use in cosmetic products for hair straightening or curling

2.5 Labelling and Claims

Labels shall be legible, clear, and truthful, preventing misuse and avoiding misleading claims such as therapeutic effects, disinfectant properties, or insect protection. In addition, cosmetic packaging shall display the details stipulated in Resolution RDC No. 907/2024.

2.6 Post-market Surveillance

According to Resolution RDC No. 894/2024, cosmetic enterprises shall have a Cosmetovigilance system in place within the national territory, which enables them to fulfill their responsibilities regarding the product safety, and ensure timely measures when necessary.

Monitoring adverse events is a key element of the Cosmetovigilance system. In the case of serious adverse events, Resolution RDC No. 894/2024 requires enterprises to report them in detail and document all follow-up actions. These records shall be retained for five years and be made available to authorities upon request.