Anvisa introduces new rules for framing, labeling, microbiology and regularization of cosmetics, personal hygiene products and perfumes in Brazil

On September 21, Anvisa’s Collegiate Board of Directors (DICOL) published resolution n. 752/2022 (Anvisa RDC n. 752/2022) in the Brazilian Official Gazette (DOU). The resolution provides for the definition, classification, technical requirements for labeling and packing, parameters for microbiological control, and the technical requirements and procedures for the regularization of personal hygiene products, cosmetics and perfumes.

With the purpose of simplifying the regularization paths of regulated products, the resolution promotes the consolidation of RDC Anvisa n. 7/2015 (which provides for the technical requirements for the regularization of personal hygiene products, cosmetics and perfumes). It also encompasses and incorporates other complementary rules applicable to the matter (eg RDC Anvisa n. 237/2018, RDC Anvisa n. 288/2019, RDC Anvisa n. 312/2019, RDC Anvisa n. 409/2020 and RDC Anvisa n. 630/2022).

The new resolution internalizes the technical regulation provided in the Mercosur Technical Regulation about labeling of personal hygiene products, cosmetics and perfumes (GMC Mercosur Resolution n. 48/21). This is to promote regulatory convergence with international standards and to ensure access to clear, accurate and updated information to consumers regarding the characteristics of regulated products. It also provides for the safety, instructions for use and effectiveness, according to the mandatory indications on the respective labels.

Details of the resolution are:

• Information related to the regularization procedures, risk classification, microbiological analysis and labeling guidelines is now all consolidated into a single normative act.
• Definitions and rules related to testers will now be included.
• New risk definitions will be included – unlike the previous RDC Anvisa n. 7/2015, which established two classes with three subclasses (ie “Risk 1,” “Risk 2 exempt from registration” and “Risk 2”), the new resolution presents only the definitions of Risk 1 and Risk 2.

Products subject to the registration procedure are those in the groups referring to:

• sun tanning products
• hand sanitizing gels
• hair straightening products
• hair straightening and dyeing products
• hair waving products
• sunscreen
• children’s sunscreen
• insect repellents and insect repellents for children

Products in the other groups of cosmetics, personal hygiene products and perfumes are exempt from registration, remaining subject only to the procedure of prior communication to Anvisa.

For the regularization of establishments which are the owners, manufacturers or importers of the class of products in question (cosmetics, personal hygiene products and perfumes), the resolution expressly states that they must have a Sanitary License at federal level before Anvisa (Autorização de Funcionamento de Empresa (AFE)) and a Sanitary License at local level before the local Sanitary Authority (Licença Sanitária).

The rule comes into effect on October 3, 2022, establishing a period of three years (ie until October 3, 2025) for products already regulated at Anvisa to meet the requirements.

Players in the sector must be aware of the new dictates of the resolution, especially regarding the labelling and packing aspects, so they can adapt to the sector’s regulations and avoid the risks possibly affecting the continuity and legality of their businesses in the Brazilian health market.

* Bruna B. Rocha is a partner, Juliana Marcondes and Victoria Cristofaro are associates, and Luiza Meira Novaes is a trainee in independent Brazilian law firm Campos Mello Advogados.