[Updated] Taiwan to Update the Applicable Products for PIF Requirements

Editor's note: This article was originally published on April 17, 2024, and was updated on June 28, 2024, as per the latest developments. The updated contents are marked in red below.

On April 11, 2024, Taiwan Food and Drug Administration (TFDA) released the draft of Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2024), aiming to replace the 2019 version.^1-2 The draft was finalized on June 26, 2024, and will take effect on July 1, 2024.^3-4

Reasons for Amendments

Currently in Taiwan, cosmetics are categorized into general cosmetics and specific purpose cosmetics based on their functions. The latter includes products used for sunscreening, hair dyeing, permanent waving, antiperspirant, deodorant, tooth whitening, and other purposes specified in the List of Specific Purpose Ingredients in Cosmetic Products. However, starting from July 1, 2024, Taiwan will cancel the specific purpose cosmetics category, transitioning to a unified management approach for all cosmetics available in the market.

The Cosmetic Hygiene and Safety Act stipulates that cosmetics manufacturers and importers in Taiwan shall establish a product information file (PIF) before engaging in the supply, sale, giveaway, public display, and free trial offer of cosmetics. To clarify the scope of PIF requirements, TFDA released the Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2019) on May 30, 2019, specifying the respective effective dates of PIF requirements for specific purpose cosmetics and general cosmetics. To align with the cancellation of the specific purpose cosmetics category, TFDA has updated the applicable scope for PIF requirements accordingly.

Details of Proposed Amendments

Since there will be only one cosmetic product category effective from July 1, 2024, the new regulation removes the terms of "specific purpose cosmetics" and "general cosmetics", and extends its scope to include certain products subject to management only in other regions and countries. Specifically, the applicable scope of PIF requirements will be revised as below:

No.	Applicable Product Type		Effective Date of PIF Requirements
No.	Before Amendment	After Amendment	Effective Date of PIF Requirements
1	Specific purpose cosmetics	Products containing sunscreens, hair dyes, permanent wave agents, antiperspirants, deodorants, home-use peroxide-contained tooth whitening agents, and other ingredients listed in the annex to this regulation; or, Products containing sunscreens, hair dyes, permanent wave agents, antiperspirants, deodorants, and home-use peroxide-contained tooth whitening agents that are not listed in the annex but currently subject to use restrictions in the EU, the United States, and/or Japan	July 1, 2024
2	General cosmetics including baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwash	Baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwash	July 1, 2025
3	Other general cosmetics (except for solid handmade soaps manufactured in factories enjoying exemption from registration)	Other products (except for solid handmade soaps manufactured in factories enjoying exemption from registration)	July 1, 2026

[Updated] Taiwan to Update the Applicable Products for PIF Requirements

Reasons for Amendments

Details of Proposed Amendments

Further Reading