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Regulatory Overview of Children’s Cosmetic Products in Brazil

Jun 05, 2025
Jarius Ji
This article outlines the compliance framework for children’s cosmetic products in Brazil, as defined in Resolution RDC No. 907/2024 and Resolution RDC No. 639/2022, with a focus on product definition, market authorization, formulation, labelling, and packaging.

Brazil has long maintained a structured regulatory framework of cosmetic products. Rooted in earlier regulations, Resolution RDC No. 907/2024 represents a significant update to this framework, reinforcing long-standing public health priorities while introducing modernized compliance requirements. It refines existing provisions to establish a comprehensive framework governing product classification, market authorization, labelling, ingredient control, and post-market surveillance.

In parallel, and in response to the need for heightened safeguards for children, the Brazilian Health Regulatory Agency (Anvisa) adopted Resolution RDC No. 639/2022 to revise and consolidate the regulatory requirements specifically applicable to children's cosmetic products. Effective on May 2, 2022, this regulation supplements Resolution RDC No. 907/2024 by introducing child-focused requirements related to formulation, labelling, and packaging.

While other regulations may also apply, Resolution RDC No. 907/2024 and Resolution RDC No. 639/2022 serve as the primary references for children's cosmetic products in Brazil. This article outlines the key compliance requirements they establish, particularly in relation to product definition, market authorization, formulation, labelling, and packaging.

Definition

In Brazil, the term "cosmetic products" refers to the field that includes personal hygiene products, cosmetics, and perfumes. These products are defined as preparations made from natural or synthetic substances with exclusive or primary purpose of cleansing, perfuming, altering appearance, correcting body odors, and/or protecting or maintaining these areas in good condition. The application sites for these products include various external parts of the human body—such as the skin, hair, nails, lips, and external genitals—as well as the teeth and the mucous membranes of the oral cavity. Built upon this definition, children's cosmetic products are those that fall within the general scope of cosmetics, and are specifically designed for children aged 0–12 years.

Annex I to Resolution RDC No. 639/2022 outlines the types of children's cosmetic products. Examples include: 

  • Personal hygiene products: shampoo, conditioner, toothpaste, mouthwash, and cleaning or sanitizing product;

  • Cosmetics: nail polish, skin moisturizer, face power, sunscreen, and insect repellent;

  • Perfumes: cologne, and perfume.

Resolution RDC No. 639/2022 further provides that product types not explicitly listed in the annex may also be evaluated and authorized for children use, as long as accompanied by sufficient safety data and a clear justification for use in children. 

Market Authorization

Before being marketed in Brazil, cosmetic products shall obtain market authorization from Anvisa through the regularization process, i.e., registration or notification. For children's cosmetic products, in accordance with Resolution RDC No. 907/2024, sunscreens and insect repellents are subject to registration, while all other products shall be notified to Anvisa prior to their commercialization.

Key Aspects

Registration

Notification

Applicable products

Sunscreens and insect repellents for children

Children's cosmetic products falling outside the registration scope

Start of commercialization

The commercialization of the product is permitted following the publication of its regularization in Brazil's Official Gazette of the Union.

The commercialization of the product is permitted following the publication of its regularization on the Anvisa portal.

Validity

The registration is valid for 10 years, with revalidation required within the first half of the final year to maintain the authorization.

Revalidation is not required. However, a declaration of intent to continue marketing the product in Brazil shall be submitted every 10 years to maintain the authorization.

Required dossiers

1)  Product purpose

2)  Quali-quantitative formula

3)  Function of formula ingredients

4)  Bibliography and/or references of ingredients

5)  Original formula (only for imported products)

6)  Organoleptic and physicochemical technical specifications of the finished product

7)  Microbiological specifications of the finished product

8)  Label artwork

9)  Stability data

10)  Supporting evidence for safe use

11)  Supporting evidence for product claims

Formulation Rules

To guarantee the safety of cosmetic products, Brazil enforces seven key regulations governing ingredient use. Considering the range of cosmetic product types applicable to children, stakeholders are generally required to comply with six of these regulations, as outlined below:

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

Additionally, Resolution RDC No. 639/2022 emphasizes that children's cosmetic products shall be formulated with ingredients that are safe and appropriate for their intended use, with a view to the risk of accidental ingestion. The formulation should also allow easy removal using water, soap, shampoo, and/or other surfactant-based preparations. Consistent with these principles, Brazil establishes comprehensive safety and formulation rules for each type of children's cosmetic products. A selection of these rules is summarized in the table below.

Product Type

Applicable Age Range

Safety Requirements

Other Conditions

Personal hygiene products

Leave-in conditioner

3 years and older

Proof of absence of skin irritation and sensitization

/

Fluoride toothpaste

All age groups

Proof of absence of oral mucosal irritation

/

Underarm deodorant

8 years and older

Proof of absence of skin irritation and sensitization

The use of antiperspirant substances is prohibited.

Cosmetics

Lip balm and lip gloss

3 years and older

a. Proof of oral toxicity assessment for ingredients

b. Proof of absence of skin irritation and sensitization

a. The use of substances that modify lip color upon contact with saliva is prohibited.

b. Exclusive use purpose: lip coloring.

Nail polish

5 years and older

a. Proof of oral toxicity assessment for ingredients

b. Proof of absence of skin irritation, sensitization, and photosensitization

a. Exclusive use purpose: nail coloring.

b. The product shall be easily rinsed off using water and soap.

Skin moisturizer

All age groups

Proof of absence of skin irritation and sensitization

Exclusive use purpose: skin hydration.  

Perfumes

Cologne and perfume

All age groups

Proof of absence of skin irritation and sensitization

/

It is worth noting that Resolution RDC No. 639/2022 allows certain cosmetic products originally intended for adults—such as soaps, and cleaning or sanitizing products with antiseptic properties—to be extended to children, provided that they meet the safety and formulation requirements specified for equivalent children's products, and do not incorporate child-oriented visuals or claims in marketing.  

Labelling and Packaging

Resolution RDC No. 907/2024 sets detailed labelling requirements for cosmetic products. It stipulates that labels shall be legible, clear, and truthful, and shall not include any content that implies characteristics or functions the product does not possess. To ensure informed consumer choices and prevent misuse, it also requires the following information to appear on the product packaging:

Type of Packaging

Required Information

Primary   packaging

  1. Warnings and use restrictions (if applicable)

  2. Product group, if not implied in the name

  3. Batch number

  4. Brand

  5. Product name

  6. Directions for use (if applicable)

Secondary   packaging

  1. Warnings and use restrictions (if applicable)

  2. Content

  3. Customer service contact information

  4. Product group, if not implied in the name

  5. Product regularization number

  6. Company Operating Authorization (AFE) number of the product regularization holder, corresponding to the product category (personal hygiene products, cosmetics, and/or perfumes)

  7. National Registry of Legal Entities (CNPJ) number of the product regularization holder

  8. Name of the product regularization holder

  9. List of ingredients (following INCI nomenclature)

  10. Product name

  11. Brand

  12. Country of origin

  13. Shelf life

  14. Directions for use (if applicable)

Notes:

All mandatory labeling information shall appear legibly in Portuguese, except for the product name and brand. The ingredient list shall follow INCI nomenclature, accompanied by the corresponding Portuguese terms.

In addition to provisions described above, Resolution RDC No. 639/2022 prescribes further labelling and packaging requirements for children's cosmetic products. It mandates that the product packaging shall not contain blunt parts, easily detachable and ingestible components, or toxic substances. It also prohibits these products in aerosol forms. Moreover, it requires clear labelling of warnings based on product types. A representative excerpt of these requirements is provided in the table below.

Product Type

Mandatory Warning Statements

Personal hygiene products

Foot deodorant

  1. Use in children under 8 years of age is not recommended;

  2. Application only by an adult or under adult supervision;

  3. Prohibition of use on irritated or damaged skin;

  4. In case of irritation, discontinue use and seek medical advice.

Body/hair oil

  1. Application only by an adult or under adult supervision;

  2. Prohibition of use on irritated or damaged skin;

  3. In case of irritation, discontinue use and seek medical advice;

  4. Avoidance of contact with mucous membranes;

  5. If the product comes into contact with eyes, rinse immediately with plenty of running water and seek medical advice.

Cosmetics

Lip balm and lip gloss

  1. Prohibition of use in children under 3 years of age;

  2. For products designed for children aged 3 to 5: Application only by an adult;

  3. For products designed for children above 5 years of age: Application only under adult supervision;

  4. Avoidance of ingestion;

  5. Prohibition of use on cracked, peeled, or wounded lips;

  6. In case of irritation, discontinue use and seek medical advice.

Nail-biting deterrent product

  1. Prohibition of use in children under 5 years of age;

  2. Application only by an adult or under adult supervision;

  3. Prohibition of use if the skin on the child's fingers or cuticles is injured or inflamed;

  4. In case of irritation, discontinue use and seek medical advice.

Perfumes

Cologne and perfume

  1. Application only by an adult or under adult supervision;

  2. For products containing alcohol: Flammable;  

  3. Prohibition of use on irritated or damaged skin;

  4. In case of irritation, discontinue use and seek medical advice.

While Resolution RDC No. 907/2024 and Resolution RDC No. 639/2022 together form the primary regulatory foundation for children's cosmetic products in Brazil, as noted earlier, other regulations may also apply depending on the specific product type. Stakeholders should remain vigilant in identifying and complying with these additional requirements. For example, sunscreens intended for children are also subject to Resolution RDC No. 629/2022, which outlines technical standards, labelling requirements, and efficacy evaluation methods for sunscreens. Similarly, insect repellents formulated for children shall conform to Resolution RDC No. 19/2013, which details technical requirements related to the safety, efficacy, and labelling of insect repellent cosmetic products.

Further Reading

Tags : Children CosmeticsPre-market ApprovalIngredientsLabeling/Claim/AdvertisingSafety AssessmentSouth AmericaBrazil
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