Cosmetics in Brazil: New Regulations Impact Personal Care Industry

In a significant move that underscores Brazil's commitment to consumer safety and the regulation of cosmetic products, the National Health Surveillance Agency of Brazil (ANVISA) has introduced new measures that impact the personal care industry. As of August 11, 2023, ANVISA's Resolution RDC 806/2023 has come into effect, ushering in changes to the list of substances that are prohibited in personal hygiene products, cosmetics, and perfumes. Notably, the updated resolution includes two prominent substances, climbazole and zinc pyrithione, which are now prohibited in cosmetics within Brazil.

Climbazole, a chemical recognized for its use in anti-dandruff agents, has been subjected to stringent regulations. The new resolution dictates that cosmetic products cannot contain climbazole in concentrations exceeding 2%. Similarly, zinc pyrithione, a preservative commonly employed in cosmetic formulations, is now limited to a maximum concentration of 1% in cosmetic products.

The implementation of these new regulations necessitates swift action from cosmetics manufacturers and producers. Businesses operating within the cosmetic industry in Brazil must fully comply with the stipulations laid out in the resolution by August 11, 2024. This compliance deadline serves as a clear indication of ANVISA's commitment to ensuring that the personal care products available to consumers meet the highest safety standards.

ANVISA's decision to update its list of prohibited substances was driven by a desire to align with international standards and best practices. The updated resolution, RDC 806/2023, is an evolution of a 2021 regulation, and it also incorporates the Mercosur technical regulation GMC 35/22. This technical regulation, shared by the four Mercosur member countries, defines the permissible substances for use in personal hygiene products, cosmetics, and perfumes. ANVISA's integration of these guidelines demonstrates its dedication to harmonizing with regional and global standards, fostering a safer environment for consumers.

It's worth noting that both climbazole and zinc pyrithione have been subjects of regulatory attention and scrutiny in various parts of the world. Within the European Union (EU), zinc pyrithione's use in cosmetic products was officially prohibited as of March 2022. This EU regulation reflected a commitment to consumer safety and aligning with scientific findings concerning this particular substance. Additionally, climbazole, while not completely banned in cosmetics in the EU, was restricted for use in new cosmetic products as of 2019. Furthermore, it has been under evaluation due to its potential classification as an endocrine disruptor—a classification that underscores the importance of its careful regulation.

ANVISA's decision to include climbazole and zinc pyrithione in its list of prohibited cosmetic substances reinforces its mission to safeguard consumers' health and well-being. By setting specific concentration limits and compliance deadlines, the agency is driving manufacturers to reevaluate their formulations and ensure that their products are in line with the new regulatory framework. This move not only benefits consumers by guaranteeing the safety of cosmetic products but also supports the broader personal care industry by promoting responsible manufacturing practices.