공지/교육
법령
[Chemlinked] Japan Revises the List of Permitted Additives in Quasi-drugs
첨부파일
등록일 2023-01-10
조회수 7397
On December 23, 2022, MHLW announced to revise 29 additives for quasi-drugs, including 19 additives permitted to use in hair dyes products.
On December 23, 2022, Japan issued two amendments to revise permitted additives in quasi-drugs products. They are Amendment to Positive List of Quasi-drug Additives1 and Amendment to Positive List of Additives in Hair Dyes2. Up to now, there are a total of 1,848 additives that can be used in hair dye products and 2,746 additives that can be used in quasi-drug products. These revisions came into effect on December 31, 2022. The main revisions are as follows:
Quasi-drug additives:
1. Deleting additive "Stearyl Dimethyl Amine", and "Methylrosanilinium Chloride".
2. Revising English name of two additives, including:
- Changing "Hydrogenated Lanolin" into "Lanolin, Hydrogenated"
- Changing "Methoxyethylene Maleicanhydride Copolymer" into "Methoxyethylene Maleic Anhydride Copolymer"
3. Amending the following six additives. Correspondingly, the ingredient names in JSQI 2021 have also been revised.
|
No. |
Previous list |
Present list |
||||
|
Additive |
English name |
Ingredient code |
Additive |
English name |
Ingredient code |
|
|
1 |
アセチルシステイン |
N-Acetyl-L-Cysteine |
100258 |
Ｎ－アセチル－Ｌ－システイン |
N-Acetyl-L-Cysteine |
520047 |
|
2 |
エタノールアミン |
Ethanolamine |
102223 |
モノエタノールアミン |
Monoethanolamine |
104313 |
|
3 |
合成ゼオライト |
Synthetic Zeolite |
540194 |
ゼオライト |
Zeolite |
520662 |
|
4 |
チオ硫酸ナトリウム（無水） |
Sodium Thiosulfate, Anhydrous |
540055 |
無水チオ硫酸ナトリウム |
Anhydrous Sodium Thiosulfate |
106771 |
|
5 |
トリクロロヒドロキシジフェニルエーテル |
Trichlorohydroxydiph enylether |
540070 |
トリクロサン |
Triclosan |
109801 |
|
6 |
二炭酸一水素三ナトリウム |
Trisodium Hydrogen Dicarbonate |
540204 |
セスキ炭酸ナトリウム |
Sodium Sesquicarbonate |
106749 |
Additives in hair dyes:
There are a wide variety of hair dye products, which can be divided into cosmetics and quasi-drugs. Generally speaking, hair manicure products (including semi-permanent hair dyes and temporary hair dyes) are regulated as cosmetics, and hair colouring products (permanent hair dyes and bleaching agents) belong to quasi-drugs.
This revision has changed the information of 19 additives in Japan Quasi Drugs: Positive List of Additives in Hair Dyes. Find the details below. In addition, enterprises can further refer to the list of Permitted Active Ingredients in Hair Dyes, to determine the type of hair dye product.
1. Deleting additive "Methylrosanilinium Chlorid".
2. Modifying additive "3-Propanol (Reagent)" as "2-Propanol (Reagent)".
3. Amending the reference specification of four additives. As shown in the table below.
|
No. |
Additive |
Reference specification (before) |
Reference specification (after) |
|
1 |
Methyl Parahydroxybenzoate |
Japan's Specifications and Standards for Food Additives (9th Edition) |
Japanese Pharmacopoeia |
|
2* |
Ammonia solution (Reagent) |
JIS K 8085:2006 |
JIS K 8085:2021 |
|
3 |
Ammonium carbonate (Reagent) |
JIS K 8613:2015 |
JIS K 8613:2021 |
|
4 |
All-rac -α-Tocopheryl Acetate |
Japan's Specifications and Standards for Food Additives (9th Edition) |
|
|
*The English name of "Ammonia solution (Reagent)" is also different from the previous. |
|||
4. The English names of the following 13 substances have been revised.
|
No. |
Additive (before) |
Additive (after) |
|
1 |
Diammonium hydrogenphosphate |
Disodium Hydrogen Phosphate |
|
2 |
Lanolin Hydrogenated |
Lanolin, Hydrogenated |
|
3 |
Thioxolone |
Tioxolone |
|
4 |
2-(2-Hydroxy-5-methylphenyl) Benzotriazole |
2-(2-Hydroxy-5-Methylphenyl) Benzotriazole |
|
5 |
Ethyl-dl -2-pyrrolidone-5-carboxylate |
Ethyl-dl -2-Pyrrolidone-5-Carboxylate |
|
6 |
Partially Hydrogenated Squalene Pentahydrosqualene |
Partially Hydrogenated Squalene |
|
7 |
L(－)-Proline (Reagent) |
L(-)-Proline (Reagent) |
|
8 |
Polyacrylalkylate Emulsion |
Polyalkylacrylate Emulsion |
|
9 |
Polyoxyethylene Polyoxypropylene 2-Decyltetradecylether |
Polyoxyethylene Polyoxypropylene 2- Decyltetradecylether |
|
10 |
Polyoxyethylene Polyoxypropylene Trimethylol propane |
Polyoxyethylene Polyoxypropylene Trimethylolpropane |
|
11 |
Polyoxyethylene Lauryl Ether (8–10 E.O.) |
Polyoxyethylene Lauryl Ether (8–10E.O.) |
|
12 |
Sodium Phosphate, Tribasic Anhydrous |
Sodium Phosphate, Tribasic, Anhydrous |
|
13 |
Methoxyethylene Maleicanhydride Copolymer |
Balm Mint Extract |
ChemLinked has updated Ingredient Search Tool, reaching 22,000+ ingredients from Chinese Mainland, ASEAN, South Korea, Japan, EU and Japan. To mitigate compliance risks, welcome to use the search tool and quickly retrieve the regulatory status of cosmetic ingredients in various regions.
Reference Links
[1] Amendment to Positive List of Quasi-drug Additives
[2] Amendment to Positive List of Additives in Hair Dyes
출처 : Chemlinked
