Personal Hygiene Products, Cosmetics and Fragrances

Publicado em 29/10/2020 16h13 Atualizado em 19/08/2025 16h57

Personal hygiene products, cosmetics and fragrances are preparations made from natural or synthetic substances, for external use in various parts of the human body, skin, hair, nails, lips, external genitals, teeth and mucous membranes of the oral cavity, with the sole or principal purpose of cleaning, perfuming, altering their appearance and/or correcting bodily odors and / or protecting or keeping them in good condition.

Market authorizations

The general regulation applicable to marketing authorization for personal hygiene products, cosmetics and fragrances in Brazil is Resolution RDC 907/2024. Only those products listed in Article 34 of this Resolution are subject to the registration approval procedures, also known as pre-marketing approval. These include products such as sunscreens and suntan products, hair straighteners, wavy hair products, topical insect repellents, and antiseptic gels for hands. In 2023, RDC 814 also included hair styling or fixing pomades among the product categories that also require pre-marketing approval.

Products not listed in Article 34 of the Resolution RDC 907/2024 or RDC 814/2023 are considered exempt from pre-marketing approval by Anvisa. These products are instead subject to a notification procedure, through which companies must inform Anvisa of their intent to market a product that is exempt from registration. The notification process is conducted online and must be completed by the Brazilian company responsible for the product in Brazil.

To submit a registration or notification request for a cosmetic product with ANVISA, companies must hold a valid AFE (Autorização de Funcionamento de Empresa). This is a mandatory authorization that allows a company to engage in activities such as the manufacture, import, export, storage, and distribution of products subject to health regulation.

For cosmetics products in Brazil, however, GMP (Good Manufacturing Practices) certification is not required. Nevertheless, companies are expected to comply with appropriate quality and safety standards aligned with good manufacturing principles to ensure product safety and consumer protection.

Registration approvals are valid for 10 years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods. Similarly, notifications are valid for 10 years from the date of completion of the online protocol, and may also be renewed for equal and successive periods.

Please note that foreign companies are not allowed to directly obtain marketing authorizations with Anvisa. In order to market products in Brazil, foreign companies must partner with Brazilian companies legally established in the country, which will act as the legal holders and responsible parties for the products imported and distributed within Brazilian territory.

International Forums

The Cosmetics and Sanitizing Products General Office (GGCOS) plays an active role in international forums that focus on the regulation and harmonization of cosmetic products. Two of the main forums in which Anvisa participates are the International Cooperation on Cosmetics Regulation (ICCR) and Mercosur.

1. International Cooperation on Cosmetics Regulation (ICCR):
Anvisa is a member of the ICCR, a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, Chinese Taipei, the European Union, Israel, Japan, Republic of Korea, and the United States. The main objective of the ICCR is to maintain the highest level of global consumer protection, while minimizing barriers to international trade. Within the ICCR, Anvisa contributes to discussions on safety, regulatory science, and best practices for cosmetics oversight. Its role involves sharing Brazil’s regulatory experience, collaborating on the development of harmonized guidelines, and supporting decisions that ensure the safety and quality of cosmetic products globally.

2. Mercosur (Southern Common Market):
Anvisa also plays an important role in the cosmetics-related working groups within Mercosur, a regional trade bloc that includes Brazil, Argentina, Paraguay, and Uruguay. In this context, Anvisa works closely with counterpart agencies from member countries to harmonize technical regulations and standards for cosmetics. This cooperation aims to facilitate trade within the region while ensuring consumer safety and regulatory consistency. Anvisa contributes by drafting proposals, participating in negotiations, and aligning national regulations with the regional framework adopted by Mercosur.

Anvisa’s involvement in the ICCR and Mercosur highlights its commitment to international collaboration and regulatory convergence. By participating in these forums, Anvisa helps to shape global and regional policies, promotes the safety and efficacy of cosmetic products, and supports innovation and competitiveness in the cosmetics industry.

Applicable regulations

The following are the main regulations applicable to the marketing authorization (registration/pre-marketing approval and notification) of personal hygiene products, cosmetics and fragrances exported to Brazil:

Resolution RDC 907/2024 - Definition, classification, technical requirements for labeling and packaging, microbiological control parameters, as well as the technical requirements and procedures for the regularization of personal hygiene products, cosmetics, and fragrances.
Resolution RDC 814/2023 - Temporary provisions for the regularization, commercialization, and use of hair styling or fixing pomades.
Resolution 906/2024 - Procedures and requirements for the regularization of cosmetic products intended for hair straightening or waving.
IN 220/2023- List of authorized active ingredients for use in cosmetic products intended for hair straightening or waving, together with the conditions and requirements for their use.
Resolution RDC 640/2022: Disposable personal hygiene products for body hygiene, which include toothbrush and dental hygiene rods, dental wires and tapes, disposable sanitary napkins, menstrual pads and flexible rods.
Resolution RDC 639/2022: Technical requirements for the pre-market approval of personal hygiene products, cosmetics and fragrances for children.
Resolution RDC 629/2022: Technical Regulation on Sunscreens in Cosmetics.
Resolution RDC 19/2013: Technical requirements for pre-market approval of topical insect repellent.
Resolution RDC 529/2021: List of substances that cannot be used in personal hygiene products, cosmetics and fragrances.
Resolution RDC 530/2021: Lists of substances which personal hygiene products, cosmetics and fragrances should not contain except under specific conditions and with specific restrictions.
Resolution RDC 645/2022: Approves the use of lead acetate, pyrogalol, formaldehyde, and paraformaldehyde in cosmetics.
Resolution RDC 528/2021: Preservatives permitted for personal hygiene products, cosmetics and fragrances.
Resolution RDC 628/2022: Colorants permitted for personal hygiene products, cosmetics and fragrances.
Resolution RDC 600/2022: UV-filters permitted for personal hygiene products, cosmetics and fragrances.
Resolution 691/2022: Industrialization, sale, or delivery for consumption, at all stages, of hydrated ethyl alcohol in all concentrations and anhydrous ethyl alcohol, as products intended for surface cleaning, disinfection, and antisepsis of skin or substances.
Resolution 42/2010: Obligation for health services in the country to provide alcoholic preparations for antiseptic hand rubbing, and sets forth other provisions.