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China Taiwan Cosmetics Regulation

In Chinese Taiwan, Food and Drug Administration (FDA) of Ministry of Health and Welfare is the competent authority regulating cosmetics. Recently, the authority updates a series of cosmetic regulations, including the overarching regulation – “Cosmetic Hygiene and Safety Act”. This new Act stipulates that "Cosmetics" means products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body. However, this is not applicable to those that are regarded as drugs in accordance with other laws or regulations.
And the category of cosmetics changes from general cosmetics and medicated cosmetics in the old regulation to general cosmetics and specific purpose cosmetics in the regulation. “Regulations for Issuance of Permit License of Specific Purpose Cosmetics” stipulates that “Specific Purpose Cosmetics” means cosmetic products used for sunscreen, hair dyes, hair perms, deodorants, teeth whitening and other functions.

The obligations of manufacturers and importers have also changed. Here is a table to show obligations for cosmetics from different categories.

General cosmeticsSpecific purpose cosmetics
NotificationRegistration
Note: from 1st July, 2024, registration will be replaced by notification and PIF.
Build product information files (PIF)

 

In another word, the newly enforced cosmetic hygiene and safety act establishes a completely new administrative system including a new notification system and requires the establishment of a PIF (product information files). Starting from the effective date (1st July, 2019), all general cosmetics can start their notification procedure through an online platform. The actual implementation date for general cosmetic notification is 1st July, 2021. After that, cosmetic products without notification will be regarded as illegal. Specific purpose cosmetics are still subject to registration, but 5 years later (1st July, 2024), they will be subject to a notification and PIF system as well.

TFDA also will implement mandatory GMP for the production of cosmetics and has also strengthened provisions related to post-market surveillance. In addition, the registration of colorants has been abolished.

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