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Editor's note: This article was originally published on January 9, 2024, and was updated on May 31, 2024, as per the latest developments. The updated contents are marked in red below.
On January 4, 2024, Taiwan Food and Drug Administration (TFDA) revealed its plans to adjust the current cosmetic ingredient lists. The proposed amendments were finalized on May 30, 2024, and will take effect on July 1, 2024.1-4
Reasons for Amendments
Cosmetic products in Taiwan fall into two categories, general cosmetics and specific purpose cosmetics. The latter category 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, in accordance with Article 5 of the Cosmetic Hygiene and Safety Act, all specific purpose cosmetics will be regulated as general cosmetics starting from July 1, 2024. To align with this change, TFDA aims to abolish the existing List of Specific Purpose Ingredients in Cosmetic Products, and reallocate its ingredients to other lists.
Additionally, EU, the United States, Japan, ASEAN, and other countries (regions), currently do not implement separate regulations on antibacterial ingredients in cosmetics. Considering this fact, TFDA plans to discontinue Taiwan's current List of Antibacterial Ingredients Allowed in Cosmetic Products, and reassign its ingredients to other lists.
Amendment Details
Upon the cancellation of the specific purpose ingredients list and the permitted antibacterial ingredients list, there will be no specific guidelines for using these ingredients. To ensure the continued safe use of them, TFDA plans to establish establishing a new list specifically for UV filters, and incorporate the remaining ingredients other than UV filters into the List of Ingredients Restricted in Cosmetic Products.
1) List of UV Filters in Cosmetic Products: newly established, containing 27 UV filters
At present, the specific purpose ingredients list includes 26 ingredients used for sunscreening. These 26 ingredients, along with Titanium Dioxide from the restricted ingredients list, will constitute the new List of UV Filters in Cosmetic Products.
List of UV Filters in Cosmetic Products (Excerpt) | |||||
Ref. No. | Chemical Name | INCI Name | CAS No. | Maximum Concentration | Precautions to be Labelled |
1 | 2-Ethylhexyl 4-(dimethylamino)benzoate / Padimate O | Ethylhexyl dimethyl PABA | 21245-02-3 | 8% | / |
2 | 2-Hydroxy-4-methoxybenz ophenone / Oxybenzone | Benzophenone-3 | 131-57-7 | 6% (When used for product protection purposes: 0.5% | Contains Benzophenone-3 (except when the substance is used for product protection, or the concentration is no greater than 0.5%). |
3 | 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt / Sulisobenzone | Benzophenone-4 / Benzophenone-5 | 4065-45-6 / 6628-37-1 | 5% (as acid) | / |
4 | Benzoic acid, 2-hydroxy-,3,3,5-trimethylc yclohexyl ester / Homosalate | Homosalate | 118-56-9 | 10% | / |
5 | 2-Ethylhexyl 4-methoxycinnamate / Octinoxate | Ethylhexyl methoxycinnamate | 5466-77-3 | 10% | / |
6 | 2-Ethylhexyl salicylate / Octisalate | Butyl methoxydibenzoylmethane | 70356-09-1 | 5% | / |
* The complete list is available here. | |||||
2) List of Ingredients Restricted in Cosmetic Products: 122 added, 31 revised, and 2 deleted
The current restricted ingredients list partially overlaps with the List of Specific Purpose Ingredients in Cosmetic Products and the List of Antibacterial Ingredients Allowed in Cosmetic Products that are set for abolition. For the overlapped ingredients, TFDA combines their use conditions specified in the two lists into the restricted ingredients list. For the rest ingredients, they are added to the restricted ingredients list with their original use conditions. TFDA also updates the applicable product types of some existing ingredients in the list following international regulations. In total, these amendments result in the addition of 122 ingredients to the restricted ingredients list, the revisions of 31 existing ingredients, and the deletion of 2 ingredients.
Amendments to the List of Ingredients Restricted in Cosmetic Products (Excerpt) | ||||||
Status | Ref. No. | Chemical Name | INCI Name | CAS No. | Product Type | Maximum Concentration |
Addition | 65 | p-Phenylenediamine and its salts | p-Phenylenediamine / p-Phenylenediamine HCl / p-Phenylenediamine sulfate | 106-50-3 / 624-18-0 / 16245-77-5 | Oxidative hair dye products | 2% (as free base) |
66 | 1,4-Benzenediamine,2-methyl- / 2,5-Diaminotoluene sulphate | Toluene 2,5-diamine / Toluene-2,5-diamine sulfate | 95-70-5 / 615-50-9 | Oxidative hair dye products | 2% (as free base) | |
67 | 5-Amino-o-cresol | 4-Amino-2-hydroxytoluene | 2835-95-2 | Oxidative hair dye products | 1.5% | |
Revision | 1 | Allantoin | Allantoin | 97-59-6 | (a) Leave-on products | (a) 0.2%
0.5% |
7 | Cantharides tincture / Capsicum tincture / Ginger tincture | / | / | Hair products | 1% (in total) | |
28 | Inorganic sulfites and bisulfites | / | / | (a) Oxidative hair dye products | (a) 0.67% (as free SO2)
| |
Deletion | Titanium Dioxide and Magnesium Fluoride are deleted. | |||||
* The detailed amendments to this list are available here. | ||||||
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