On January 28, 2026, the Ministry of Health of Chile (Ministerio de Salud, MINSAL) submitted notification G/TBT/N/CHL/781 to the World Trade Organization (WTO), proposing the issuance of a National Technical Standard for Cosmetic Surveillance. The deadline for submitting comments is March 29, 2026.
Background and Purpose
In Chile, the regulation of cosmetics is governed by Supreme Decree No. 239/2002 issued by the Ministry of Health, which approved the Regulation of the National System for Cosmetic Control. This regulation defines the obligations of manufacturers, importers, and marketing authorization holders, as well as the supervisory role of health authorities.
However, regulatory experience in recent years has highlighted the need to establish a dedicated post-market surveillance system for cosmetics, with the following objectives:
- To promptly identify and record adverse events associated with the use of cosmetic products;
- To assess and manage the risks arising from such events, and to implement proportionate and timely risk mitigation measures to protect public health;
- To promote the active participation of various stakeholders, including marketing authorization holders, healthcare professionals, health institutions, distribution channels, and end users;
- To align Chile’s cosmetic regulatory framework with international standards.
The establishment of this system is expected to strengthen the country’s capacity for cosmetic safety oversight and enhance the protection of public health.
Key Provisions
The proposed technical standard includes the following main components:
- Scope and Objectives of the Surveillance Program, including both general and specific objectives;
- Public Consultation Procedures, detailing the purpose, target participants, timeline, methods for collecting and processing comments, and publication of final outcomes;
- Technical Framework for Cosmetic Adverse Event Monitoring, including an introduction and scope of application;
- Roles and Responsibilities of Stakeholders, such as marketing authorization holders and healthcare professionals.
This initiative represents a significant step toward modernizing Chile’s cosmetic regulatory system and ensuring the safety and well-being of consumers.
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Further Information:
WTO G/TBT/N/CHL/781
