Japan Revises the List of Permitted Additives in Quasi-drugs and in Hair Dyes

On December 23, 2022, MHLW announced the 29 quasi-drug additives, including 19 additives that are allowed to be used in hair colour products, will be revised. Japan published two modifications on December 23, 2022, to change the allowed additives in items classified as quasi-drugs. The two are Amendment to Positive List of Additives in Hair Dyes and Amendment to Positive List of Quasi-drug Additives, respectively. There are currently 2,746 additives that can be used in quasi-drug goods in addition to the 1,848 additives that can be used in hair dye products. The changes took effect on December 31, 2022. The following are the primary revisions:                                                                                                                                                                                                                                   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.                           
1) Previous Additive was N-Acetyl-L-Cysteine and present is in English Name: N-Acetyl-L-Cysteine : Ingredient code: 520047
2) Previous Additive was Ethanolamine and present in English Name: Monoethanolamine: Ingredient code: 104313
3) Previous Additive was Synthetic Zeolite and present in English Name: Zeolite: Ingredient code: 520662
4)Previous Additive was Sodium Thiosulfate, Anhydrous and present in English Name: Anhydrous Sodium Thiosulfate: Ingredient code: 106771
5)Previous Additive was Trichlorohydroxydiph enylether and present in English Name: Triclosan: Ingredient code: 109801
6)Previous Additive was Trisodium Hydrogen Dicarbonate and present in English Name: Sodium Sesquicarbonate: Ingredient code: 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 given below.                                                                                                                          i) For Additive: Methyl Parahydroxybenzoate previous Reference specification (before) was Japan's Specifications and Standards for Food Additives (9th Edition) and now at present is Japanese Pharmacopoeia.
ii) For Additive: Ammonia solution (Reagent) previous Reference specification (before) was JIS K 8085:2006 and now at present is JIS K 8085:2021
iii) For Additive: Ammonium carbonate (Reagent) previous Reference specification (before) was JIS K 8613:2015 and now at present is JIS K 8613:2021
iv) For Additive: All-rac -α-Tocopheryl Acetate previous Reference specification (before) was Designated Additives List and now at present is 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.

1) Additive (before) was Diammonium hydrogenphosphate and  Additive (after) is: Disodium Hydrogen Phosphate
2) Additive (before) was Lanolin Hydrogenated and  Additive (after) is: Lanolin, Hydrogenated
3) Additive (before) was Thioxolone and  Additive (after) is: Tioxolone
4)Additive (before) was 2-(2-Hydroxy-5-methylphenyl) Benzotriazole and Additive (after) is: 2-(2-Hydroxy-5-Methylphenyl) Benzotriazole
5)Additive (before) was Ethyl-dl -2-pyrrolidone-5-carboxylate and  Additive (after) is: Ethyl-dl -2-Pyrrolidone-5-Carboxylate
6)Additive (before) was Partially Hydrogenated Squalene Pentahydrosqualene and  Additive (after) is:Partially Hydrogenated Squalene
7)Additive (before) was L(－)-Proline (Reagent) and  Additive (after) is: L(-)-Proline (Reagent)
8)Additive (before) was Polyacrylalkylate Emulsion and  Additive (after) is: Polyalkylacrylate Emulsion
9)Additive (before) was Polyoxyethylene Polyoxypropylene 2-Decyltetradecylether and  Additive (after) is: Polyoxyethylene Polyoxypropylene 2- Decyltetradecylether
10)Additive (before) was Polyoxyethylene Polyoxypropylene Trimethylol propane and  Additive (after) is: Polyoxyethylene Polyoxypropylene Trimethylolpropane
11)Additive (before) was Polyoxyethylene Lauryl Ether (8–10 E.O.) and  Additive (after) is: Polyoxyethylene Lauryl Ether (8–10E.O.)
12)Additive (before) was Sodium Phosphate, Tribasic Anhydrous and  Additive (after) is: Sodium Phosphate, Tribasic, Anhydrous
13)Additive (before) was Methoxyethylene Maleicanhydride Copolymer and  Additive (after) is: Balm Mint Extract