To enhance the safety of cosmetic use, the Ministry of Health and Welfare has been implementing the Product Information File (PIF) system in phases since 2019. Starting July 1, 2024, PIFs have been required for sunscreens, hair dyes, perm agents, antiperspirants, and home-use tooth whitening products containing peroxide. From July 1, 2025, cosmetics for babies, lips, eyes, as well as general toothpaste and mouthwash, must also comply. Finally, beginning July 1, 2026, all cosmetic products—except handmade solid soaps produced by entities exempt from factory registration—must have a PIF established before being marketed, sold, or provided for consumer use.
Each PIF must include 16 items such as product details, ingredient names and concentrations, manufacturing process, toxicological data, stability test reports, and a comprehensive safety assessment, all signed by a qualified safety assessor. This ensures safety through thorough documentation and scientific evaluation.
To facilitate regulatory compliance, the Taiwan Food and Drug Administration (TFDA) offers the Guidelines on the Establishment of Cosmetic Product Information File, along with documents templates for various product types (e.g., sunscreens, hair dyes, perm agent).Online training is also available via the Medical Device and Cosmetic e-Learning Platform (https://mdcel.fda.gov.tw/mooc/explorer.php) to help businesses better understand the applicable requirements and successfully establish their product information files.
