Huge changes for the cosmetics regulations published by Taiwan FDA
There are huge changes for the cosmetics regulations published by Taiwan FDA since May 30th, 2019. The main regulation is so called [Guidance of Product Information File (PIF) Management for Cosmetics].
The changes include the followings:
1.The term of medicated cosmetics will be no longer official terms and the term of specific purpose cosmetics will be the official category name for the cosmetics that are not belong to general cosmetics. The ones that emphasize the functions in addition to beauty function will be in this category.
2.Starting from July 1st, 2021, all cosmetics (domestic and imported ones) will be required for product notification(filing) without safety assessment report for the product.
3.Starting from July 1st, 2024, the specific purpose cosmetics will be required for PIF with safety assessment report for the product.
4.Starting from July 1st, 2025, the cosmetics for baby/lips/eyes and toothpastes/mouth rinse agents will be required for PIF with safety assessment report for the product.
5.Starting from July 1st, 2026, the general cosmetics will be required for PIF with safety assessment report for the product.
2021/7/1 product notification(filing) (without SA)
2024/7/1 PIF (including SA) for specific purpose cosmetics
2025/7/1 PIF (including SA) for cosmetics for baby/lips/eyes and toothpastes/mouth rinse agents
2026/7/1 PIF (including SA) for general cosmetics
Product notification(filing) and PIF need to be done by the cosmetics producers or importers. As the producers, you may think about consign a third-party license holder for you as either product notification(filing) or PIF contains the formula and process parameters which should be the trade secret for producers. If the product is produced by more than one producer, then the information for all producers needs to be listed for product notification(filing) or PIF. In terms of safety assessment report (SA report), Taiwan FDA requires the safety assessors need to be qualified by Taiwan FDA (like the way employed in EU).
Please browse Assistance with Taiwan FDA Regulations