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[Updated] Taiwan Updates the Applicable Products for GMP Requirements

In line with the discontinuation of the specific purpose cosmetics category from July 1, 2024, the new regulation revises the terminology used in it, and clarifies its applicable scope.

Editor's note: This article was originally published on May 13, 2024, and was updated on July 3, 2024, as per the latest developments. The updated contents are marked in red below.

On May 10, 2024, Taiwan Food and Drug Administration (TFDA) announced the draft of Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations, intended to replace its predecessor titled Cosmetic Categories That Shall Comply with Cosmetics Good Manufacturing Practice Regulations.1-2 The draft was finalized on June 28, 2024, and came into force upon its release.3-4

Within Taiwan's cosmetic regulatory framework, Good Manufacturing Practices (GMP) is mandatory for both manufacturers and importers. According to the Cosmetic Categories That Shall Comply with Cosmetics Good Manufacturing Practice Regulations, the implementation dates for GMP compliance differ for specific purpose cosmetics and general cosmetics. Effective July 1, 2024, Taiwan canceled the specific purpose cosmetics category, and adopted a unified management approach for all cosmetics in the market. To align with this transition, TFDA has accordingly updated the applicable scope for GMP requirements.

To be specific, the new regulation removes the terms of "specific purpose cosmetics" and "general cosmetics" from the regulation, and further clarifies its scope to prevent potential confusion resulted from the change in cosmetic product categories. Consequently, the applicable scope for GMP requirements is revised as follows: 

No.Applicable Product TypeEffective Date of GMP Requirements
Before AmendmentAfter Amendment
1Manufacturing premises of specific purpose cosmetics

Manufacturing premises of products containing ingredients listed in the annex to this regulation; or,

Manufacturing premises of 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
2Manufacturing premises of general cosmetics including baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwashManufacturing premises of baby products, lip products, eye products, as well as non-medicated toothpaste and mouthwashJuly 1, 2025
3Manufacturing premises of other general cosmetics (except for solid handmade soaps manufactured in factories enjoying exemption from registration)Manufacturing premises of other products (except for solid handmade soaps manufactured in factories enjoying exemption from registration) July 1, 2026

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