Public Consultations Published on Lists of Permitted, Restricted-Use or Prohibited Substances in Personal Hygiene Products, Cosmetics and Perfumes

On December 31, 2024, the Brazilian Health Regulatory Agency (“ANVISA”) published in the Official Gazette of the Federal Government (“DOU”) two important public consultations concerning personal hygiene products, cosmetics and perfumes: (i) Public Consultation No. 1,304, dated December 27, 2024 (“PC No. 1,304/2024”); and (ii) Public Consultation No. 1,305, dated December 27, 2024 (“PC No. 1,305/2024”).

Both consultations arise from the need to update the lists of substances permitted for use (preservatives, colorants, filters and hair straighteners), restricted-use substances, and prohibited substances in personal hygiene products, cosmetics and perfumes, with the aim of incorporating the most recent scientific research findings on the toxicity of substances used in these products. However, there is an important distinction between them:

• While PC No. 1,304/2024 presents an updated proposal for the NEGATIVE LIST, i.e., the list of substances that may not be used in such products, PC No. 1,305/2024 updates the RESTRICTED-USE LIST, establishing substances that may only be used under the conditions and subject to the restrictions set forth in the applicable regulation.

It is important to note that both consultations were exempted from Regulatory Impact Analysis (“RIA”), on the grounds that they seek to maintain “convergence with international standards,” pursuant to Article 4, item VI, of Decree No. 10,411, dated June 30, 2020, and Article 18, item V, of Ordinance No. 162, dated March 12, 2021, which respectively establish rules concerning RIA and guidelines and procedures for improving regulatory quality at ANVISA.

The deadline for submitting contributions began on January 7, 2025, and will end on March 7, 2025. To participate, the respective forms available through the links indicated in the original publication must be completed.

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