The Brazilian Health Regulatory Agency (Anvisa) has opened Public Consultation No. 1,353/2025 to discuss the regulation of handmade cosmetics, personal hygiene products, and perfumes. The proposal implements Law No. 15,154/2025, which amended Law No. 6,360/1976 and established a new simplified regulatory framework for this type of production.
This initiative aims to recognize and regulate the growing market for handmade cosmetics, setting minimum technical requirements and safety and quality criteria for small-scale manufacturers.
The draft Collegiate Board Resolution (RDC) and Normative Instruction (IN) submitted for public consultation propose the following measures:
- Definition of handmade cosmetic products as those produced on a small scale, without automated machinery, and intended for direct sale to the final consumer;
- Exemption from sanitary registration for products that meet the simplified technical requirements;
- Establishment of good manufacturing practices for artisanal production, including microbiological control and specific labeling requirements;
- Creation of a list of eligible products under the artisanal regime, detailed in the draft Normative Instruction;
- Sanitary surveillance focused on product safety and traceability.
The proposals were approved by Anvisa’s Collegiate Board, as reflected in Vote No. 177/2025, which highlights the transitional nature of the regulatory framework and the use of Regulatory Impact Analysis (RIA) as the foundation for the new model.
The public consultation will remain open for 45 days starting October 13, 2025, during which companies, associations, and individuals may submit comments through the Participa + Brasil platform.
This initiative represents a significant step toward the formalization of artisanal production, with the potential to reduce costs and entry barriers for small manufacturers, foster innovation and sustainability in the cosmetics and personal care sector and increase attention to good manufacturing practices and technical compliance, even under a simplified regime. It may also lead to adjustments in labeling, documentation, and quality control processes for established companies.
Conversely, products that do not fall under the definition of “handmade” will remain subject to the traditional notification or registration requirements.
Anvisa’s proposed regulation seeks to strike a balance between consumer safety and the promotion of artisanal economic activity, while reinforcing technical responsibility and transparency across the sector.
Our Regulatory and Life Sciences team is closely monitoring the progress of Public Consultation No. 1,353/2025 and is available to assist companies in impact assessment, participation in the consultation process, and regulatory compliance with the forthcoming rules.