On March 28, 2024, Taiwan Food and Drug Administration (TFDA) announced its intention to repeal five regulations and implement a new regulation, in response to the discontinuation of the product category of specific purpose cosmetics. The proposed amendments are open for comments until May 27, 2024, and set to take effect on July 1, 2024.1-6
Proposed repealing of five regulations
Article 5 of the Cosmetic Hygiene and Safety Act outlines the pre-market requirements for specific purpose cosmetics. These requirements will no longer be applicable starting from July 1, 2024, as per stipulated in the seventh paragraph of the same Article. All specific purpose cosmetics will be regulated as general cosmetics thereafter. To align with this change, TFDA proposes abolishing five regulations on specific purpose cosmetics. The details of these regulations are provided in the table below:
No. | Regulation | Description |
1 | Regulations for Issuance of Permit License of Specific Purpose Cosmetics | This regulation defines specific purpose cosmetics, and establishes the application dossier requirements for obtaining, modifying, and renewing the permit license for this product category. |
2 | Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics | This regulation governs the import of specific purpose cosmetics exempted from permit license application. It designates two types of products eligible for import, i.e., those imported for inspection and registration, and those imported for research, as well as their respective dossier requirements for import authorization.
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3 | Import Limits for Personal Use Specific Purpose Cosmetics Exempted from Inspection and Registration | This regulation sets quantity limitation for specific purpose cosmetics imported for personal use. In particular, these cosmetics are exempted from the registration with TFDA, if the quantity of each product category does not exceed 12 bottles (boxes, jars, bags, based on the original packaging), and the total quantity does not exceed 36 bottles (boxes, jars, bags, based on the original packaging). |
4 | Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified | This regulation stipulates the information on cosmetic labels, instructions, and packaging that specific purpose cosmetics manufacturers can modify without approval from TFDA. |
5 | Cosmetic Categories Required to Complete Product Notification and Effective Dates | This regulation specifies the respective effective dates of the notification requirement for general cosmetics and specific purpose cosmetics. Specifically: For general cosmetics: July 1, 2021 For specific purpose cosmetics: July 1, 2024
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Establishment of new regulation
Following the discontinuation of the Cosmetic Categories Required to Complete Product Notification and Effective Dates, TFDA intends to establish the Cosmetic Categories Required to Complete Product Notification to formally stipulate the product categories that require notification. According to the proposed draft, except for solid handmade soaps manufactured in factories enjoying exemption from registration, all other cosmetic categories shall fulfil the notification requirement.
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