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Tuesday, February 3, 2026Regulation

Chile notifies the details of its Cosmetovigilance system

Le Chili notifie les modalités de son système de Cosmétovigilance

On January 28, 2026, Chile notified a new cosmetovigilance system for cosmetic products, along with its various stages. The date of entry into force has not been specified at this stage. The consultation is open until March 29, 2026.

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In its explanatory memorandum, the Chilean Ministry of Health explains that currently, cosmetics regulation is primarily governed by Supreme Decree No.239/2002, approving the Regulations of the National Cosmetic Product Control System.
These regulations establish the obligations of manufacturers, importers and registration holders, as well as the supervisory role of the health authority.

However, experience in recent years has demonstrated the need for a specific post-marketing surveillance system that would:
• Detect and record in a timely manner adverse events associated with the use of cosmetic products
• Evaluate and manage the risks arising from such events, applying proportionate and timely measures to protect the public
• Promote the participation of the various stakeholders, such as registration holders, health professionals and establishments, retail outlets and consumers
• Align Chile with international standards, in particular with the commitments undertaken within the framework of the Pacific Alliance and other regional integration forums

The notified text

The Technical Standard of the National Cosmetovigilance Program specifies:
• The definition of roles and responsibilities, including mandatory and voluntary reporting mechanisms
• The establishment of a structured process for managing adverse events, from detection to the adoption of health measures
• The integration of …

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