Japan Proposes Amendments to the Japanese Standards of Quasi-drug Ingredients 2021
Japan Cosmetics Quasi-drug
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On October 30, 2026, Japan’s Pharmaceutical Review Management Division of the Pharmaceutical Bureau of the Ministry of Health, Labour and Welfare (MHLW) released the draft amendment to the Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021) for public comment. The comment period runs from October 30, 2026 to November 28, 2026. The amendment is proposed to apply from March 2027 (tentative), with a transition period of one year and six months.

Background

Under Japan’s Pharmaceuticals and Medical Devices Act, quasi-drugs are a product category between cosmetics and pharmaceuticals, covering medicated cosmetics, antiperspirant deodorants, hair restorers, oral cleaning agents, and other products.

The Japanese Standards of Quasi-drug Ingredients (JSQI) is the official standard document that sets specifications for raw material ingredients which are not included in the Japanese Pharmacopoeia, Japan’s Specifications and Standards for Food Additives, or the Japanese Industrial Standards (JIS), and which are permitted for use in quasi-drugs and related products.

The current Japanese Standards of Quasi-drug Ingredients 2021 (hereinafter “JSQI 2021”) was published on March 25, 2021, replacing the 2006 edition. This notice proposes a comprehensive revision of the monographs and other provisions of JSQI 2021.

Main Content of This Amendment

The draft amendment mainly covers four aspects:

1. Revision of the 4 qualitative reaction tests under item 47 “Qualitative Reactions” of the General Tests;

2. Revision of item 81 “Reagents and Test Solutions” of the General Tests, with 4 items added and 2 items revised;

3. Comprehensive revision of the monographs, covering 114 items;

4. Improvement of other related provisions.

Revision of “Qualitative Reactions” in the General Tests

This amendment revises the reagent descriptions and procedural descriptions of four qualitative reaction tests, namely citrate, fluoride, magnesium salt and phosphate (orthophosphate). The main changes include:

  • Fluoride test: the mixed solution of alizarin complexone test solution, pH 4.3 acetic acid-potassium acetate buffer solution and cerium(III) nitrate test solution (1:1:1) is adopted, and the description of the mixed solution is standardized;
  • Magnesium salt test: the description for judging the observation of a white gelatinous precipitate formed in sodium hydroxide test solution is revised, clarifying that the precipitate does not dissolve even when excess sodium hydroxide test solution is added, and the order of the description that iodine test solution turns the precipitate dark brown is adjusted
  • Phosphate (orthophosphate) test: the test solution is limited to a dilute nitric acid acidic solution (the wording “neutral or dilute nitric acid acidic” in the current version is deleted).

Revision of “Reagents and Test Solutions” in the General Tests

Four reagents and test solutions are newly added:

  • Ethanol, neutralized, dilute;
  • 14% cyanopropylphenyl-86% dimethylpolysiloxane polymer for gas chromatography;
  • 14% cyanopropylphenyl-86% dimethylpolysiloxane polymer, for gas chromatography;
  • Hinokitiol, for assay (purity 99.0% or more).

Two items are also revised:

  • “Ethanol, neutralized” item: the description of the amount of phenolphthalein test solution is standardized from “2 drops or 3 drops” to “2 to 3 drops”;
  • “0.0025 mol/L potassium polyvinyl sulfate test solution” item: the content of potassium polyvinyl sulfate (C2H3SO4K, 162.21) per 1000 mL is corrected from 0.04055 g to 0.4055 g.

Revision of the Monographs (114 Items)

This amendment comprehensively revises 114 items of the monographs, covering raw materials commonly used in quasi-drugs, such as fatty acid metal salts, sorbitan fatty acid esters, various surfactant solutions, camphor, hinokitiol, d-α-tocopheryl acetate, rose water and rosemary water. Based on the old-new comparison table, the main types of revisions are as follows:

  • Standardization of textual expressions
  • Correction of molecular formulas and molecular weights
  • Updates to test methods
  • Adjustment of physicochemical specifications
  • Updates to information such as raw material sources

CIRS Reminder

Japan’s MHLW has released the draft amendment to JSQI 2021 for public consultation until  November 28, 2026. The revision covers general test procedures, reagents/test solutions and 114 monographs of quasi-drug ingredients, with tentative enforcement in March 2027 and an 18-month transition period.

Stakeholders supplying raw materials or placing quasi-drugs on the Japanese market are suggested to review the updated test methods and specifications, submit comments as appropriate, and prepare for specification and testing method updates in advance.

Our Services

  • Cosmetics Notification & Quasi-drug Registration
  • Formula and Label Review
  • Dossier Preparation
  • Testing Required for Notification

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information
Public comment on the draft amendment to the Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021)

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