事 務  連  絡令和３年９月30日各都道府県衛生主管部（局）薬務主管課　御中厚生労働省医薬・生活衛生局医薬品審査管理課染毛剤製造販売承認基準の英訳について医薬部外品のうち、染毛剤の製造販売の承認基準については、「染毛剤製造販売承認基準について」 (令和３年６月28日付け薬生発0628第７号厚生労働省医薬・生活衛生局長通知)により示してきたところですが、別添のとおり、当該基準の英訳を作成したのでお知らせいたします。なお、本事務連絡の発出に伴い、「染毛剤製造販売承認基準の英訳について」 (平成27年11月11日付け厚生労働省医薬食品局審査管理課事務連絡）は廃止します。 Provisional Translation From Japanese Original June 28, 2021 Notification PSEHB No.0628-7

1. Scope of the standards
These standards are applicable to external preparations for hair intended to be used for hair dyeing, hair dye removal and hair bleaching, excluding those for bleaching of unwanted hair on arms and legs and those for direct hair dyeing by simple physical means (categorized as cosmetics); these preparations are hereinafter referred to as "hair coloring agents", regardless of ingredients contained therein.
2. Standards
The following standards are applied to hair coloring agents of quasi-drugs. For hair coloring agents which do not conform to the approval standards, documents regarding its efficacy, safety, and ingredient formulation, purpose, etc. shall be submitted for review for approval.
(1) Active ingredients
Active ingredients which are permitted to be used shall be those listed in the attached Table 2 and Table 2-2, and their corresponding usage classifications shall be listed in the attached Table 1.
A. Oxidative hair coloring agents
(a) In the case of three-agent type preparations The first agent: If a preparation does not contain any of the active ingredients listed in Column I- C of the attached Table 2, it is possible that the preparation shall contain at least one or more active ingredients listed in Column I-A, and it may also, as necessary, contain an active ingredient listed in Column I-B of the attached Table 2. If a preparation contains an active ingredient listed in Column I-C of the attached Table 2, the preparation must contain one of the combinations of the active ingredients listed from Column I-A to I-N, and shall also contain at least one or more active ingredients listed in Column II of the attached Table 2-2. The second agent: The preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2. The third agent: The preparation may contain an active ingredient(s) listed in Column IV of the attached Table 2. (b) In the case of two-agent type preparations The first agent: If a preparation does not contain any of the active ingredients listed in Column I- C of the attached Table 2, it is possible that the preparation shall contain at least one or more active ingredients listed in Column I-A, and it may also, as necessary, contain an active ingredient listed in Column I-B or Column IV of the attached Table 2. If a preparation contains an active ingredient listed in Column I-C of the attached Table 2, the preparation must contain one of the combinations of the active ingredients listed from Column I-A to I-N, and shall also contain at least one or more active ingredients listed in Column II of the attached Table 2-2, and it may also, as necessary, contain an active ingredient listed in Column IV of the attached Table 2 The second agent: The preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2.  However, for a single item application in which the first agent contains an active ingredient listed in Column II of the attached Table 2, the second agent shall not contain any active ingredient listed in the same column. (c)In the case of single-agent type preparations A preparation shall contain at least one or more active ingredients listed in Column I-A of the attached Table 2 and it may also, as necessary, contain active ingredients listed in Column I-B, II, or IV of the attached Table 2. B. Non-oxidative hair coloring agents (a) In the case of a two-agent type preparation The first agent: A preparation shall contain the active ingredients listed in Column III, V-B or V-C of the attached Table 2, as necessary. The second agent: A preparation shall contain at least one or more active ingredients listed in Column V-A of the attached Table 2 and it may also, as necessary, contain the active ingredients listed in Column V-B of the attached Table 2. However, at least one or more active ingredients listed in Column V-B of the attached Table 2 shall be contained into only one of either the first agent or the second agent. (b) In the case of a single-agent type preparation A preparation shall contain at least one or more active ingredients of those listed in both Columns V-A and V-B of the attached Table 2 and it may also, as necessary, contain an active ingredient listed in Column V-C of the attached Table 2. C. Hair bleaching agents/Hair dye removal agents (a) In the case of a three-agent type preparations The first agent: A preparation shall contain at least one or more active ingredients listed in Column III of the attached Table 2. The second agent: A preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2. The third agent: A preparation shall contain at least one or more active ingredients listed in Column IV of the attached Table 2. (b) In the case of a two-agent type preparations The first agent: A preparation shall contain at least one or more active ingredients listed in Column II, III, or IV of the attached Table 2 and it may also, as necessary, contain an active ingredient listed in Column III or IV of the attached Table 2.  However, for single item application, the preparation shall not contain any active ingredients listed in Column II of the attached Table 2. The second agent: A preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2 and it may also, as necessary, contain an active ingredient listed in Column IV of the attached Table 2. (c) In the case of a single-agent type preparation A preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2 and it may also, as necessary, contain an active ingredient listed in Column III or IV of the attached Table 2. D. Oxidants of oxidative hair coloring agents or hair bleaching agents/hair dye removal agents A preparation shall contain at least one or more active ingredients listed in Column II of the attached Table 2. E. Oxidation aids of oxidative hair coloring agents or hair bleaching agents/hair dye removal agents A preparation shall contain at least one or more active ingredients listed in Column IV of the attached Table 2.
(2) Amount of active ingredients
A. For active ingredients listed in the attached Table 2 and Table 2-2 specified by the maximum concentration for use in the Tables, the maximum content shall not exceed the specified value of maximum concentration for use, which is calculated in terms of the concentration for use and listed in the Tables. B. If at least two or more active ingredients in Column I-A or Column I-C of the attached Table 2 are contained in the agents, the total concentration (%) of active ingredients for use shall not exceed 5.0%. C. For hydrogen peroxide and hydrogen peroxide solution as listed in Column II of the attached Table 2, the total concentration of hydrogen peroxide in the product shall not exceed 6.0%.
(3) Standards of active ingredients
The standards of active ingredients shall be as shown in the attached Table 2 and Table 2-2.
(4) Types, standards and maximum amount of additives
Types, standards, and maximum amount of additives shall be provided by the notification from the Director of the Pharmaceutical Evaluation Division in Pharmaceutical Safety and Environmental Health Bureau of the Ministry of Health, Labour and Welfare. (5) Each active ingredient listed in the attached Table 2 and Table 2-2 shall be specified with the standards of the "Japanese Standards of Quasi-Drug Ingredients" (indicated by a "Q" in the Tables), the Japanese Pharmacopoeia (indicated by a “P” in the Tables), Japan’s Specifications and Standards for Food Additives (indicated by an "F" in the Tables), or Japanese Industrial Standards (indicated by a "J" in the Tables).
(6) Product forms
The product forms shall be powder, tablet, aerosol, liquid or cream, etc. which shall not be misidentified to be medicinal products. (7) Dosage and administration Product labels shall clearly indicate the correct dosage and administration, leaving no room for misuse.
(8) Indications
Product indication shall be selected from hair dyeing, hair dye removal and hair bleaching depending on the intended use. [Attached Table 1]
1) Three-agent type oxidative hair coloring agents having a paste form, third agent of which shall not contain an active ingredient. 2) Two-agent type oxidative hair coloring agents which consist of a first agent containing the active ingredients in Column II and a second agent containing a diluent, etc. without active ingredients. [Attached Table 2]
[Attached Table 2-2]