Taiwan Implements New Cosmetic Regulations Effective 1 July 2024

The Taiwan Food and Drug Administration (TFDA) has announced significant regulatory changes for the cosmetics industry, set to take effect on 1 July 2024. These changes primarily involve the restructuring of cosmetic ingredient lists and the reclassification of specific purpose cosmetics to general cosmetics, as well as enhanced reporting and compliance requirements. These updates are designed to ensure the safety and quality of cosmetic products.

Restructuring of Ingredient Lists

The TFDA will abolish the current List of Specific Purpose Ingredients and the List of Antibacterial Ingredients Allowed in Cosmetic Products. A new List of UV Filters will be established, and changes will be made to the List of Ingredients Restricted in Cosmetic Products. This includes the addition of 122 new ingredients, the revision of 31 ingredients and the deletion of 2 ingredients from the restricted list.

Reclassification of Cosmetics

Starting 1 July 2024, specific purpose cosmetics (e.g., sunscreen, hair dye, tooth whitening) will be reclassified as general cosmetics. This transition will shift the regulatory requirements from pre-market registration to a more streamlined notification process and the establishment of a Product Information File (PIF). This change aims to simplify the compliance process for cosmetic companies, reduce the administrative burden and expedite product launches.

Compliance and Reporting Requirements

Cosmetics manufacturers and importers must comply with the new notification system and prepare PIFs for inspection by the TFDA. The notification system will require detailed information about the product, including safety assessments and compliance with Good Manufacturing Practices (GMP).

Phased Compliance Schedule

To facilitate a seamless transition, the TFDA has established a phased compliance schedule:

• Specific Purpose Cosmetics: Must comply by 1 July 2024.

• Non-Specific Purpose Cosmetics for Infants, Lips, or Eyes: Compliance required by 1 July 2025.

• Other Non-Specific Purpose Cosmetics: Compliance required by 1 July 2026.

The new regulations are designed to improve the safety and quality of cosmetic products. Cosmetics companies are advised to prepare for these changes to ensure seamless compliance by the 1 July 2024 deadline.