Brazil’s Public Consultations No. 1304 and 1305/2024: Major Updates to Cosmetic Substance Regulations

On December 27, 2024, ANVISA announced two critical public consultations—No. 1,304 and No. 1,305—aimed at revising regulations for substances used in personal hygiene products, cosmetics, and perfumes. These updates are set to improve consumer safety, align with international standards, and strengthen Brazil’s position in the global cosmetics market.

Key Updates in Public Consultations No. 1,304 and 1,305

• Public Consultation No. 1,304: Focuses on the restrictive list (Lista Restritiva), identifying substances permitted for use under specific conditions and limitations. This includes preservatives, colorants, filters, and straighteners.

• Public Consultation No. 1,305: Addresses the negative list (Lista Negativa), banning substances deemed unsafe for use due to their toxicity. Examples include Lilial, Lyral, and selenium disulfide.

Why Are These Updates Important?

These revisions aim to incorporate the latest scientific research on ingredient safety, reducing health risks while promoting global competitiveness for Brazilian cosmetics. By aligning with international regulatory benchmarks, ANVISA is ensuring Brazilian products meet global standards for safety and quality.

How to Participate

• Contribution Period: January 7, 2025, to March 7, 2025

• Stakeholders can submit their input through ANVISA’s official forms, with detailed guidance available on the consultation page. This process invites contributions from industry experts, public health advocates, and other stakeholders.

Key Regulatory Highlights

1. Restrictive List (Consultation No. 1,304):

   • Updates substances that are permitted with restrictions based on safe usage levels.
   • Focuses on refining conditions for preservatives, filters, and other cosmetic components.

2. Negative List (Consultation No. 1,305):

   • Expands the list of banned substances to enhance consumer protection.
   • Includes substances flagged for their health risks by the latest toxicological studies.

Supporting Documentation

ANVISA has provided detailed resources, including:

• Scientific assessments of key substances.
• Meeting agendas outlining  regulatory discussions.
• International benchmarks to support the proposed updates.

Why These Changes Matter

Updating the restrictive and negative lists:

• Protects consumer health by addressing the risks of toxic substances.
• Strengthens Brazil’s competitiveness in the global cosmetics market by aligning with international safety standards.
• Promotes innovation and transparency in regulatory practices.

Next Steps

After the consultation period ends, ANVISA will analyze contributions and finalize the regulatory updates. These changes will ensure Brazilian personal care and cosmetic products meet evolving safety standards while maintaining global market relevance.

For more information and to participate, you can access Consultation No. 1,304 here *in Portughese) and Consultation No. 1,305 here (in Portuguese).