Japan Proposes to Amend Quasi-drug Ingredients Standards

JSQI 2021 is a compiled document of ingredient that are allowed to be used in quasi-drugs and other products, excluding those listed in the Japanese Pharmacopoeia, Japan's Specifications and Standards for Food Additives, and Japanese Industrial Standards. Japan MHLW proposes amendments for test methods, standard solutions and samples, involving 222 ingredients.

On September 13, 2024, Japan Ministry of Health, Labour and Welfare (MHLW) released a proposal for Japanese Standards of Quasi-drug Ingredients 2021, which covers test method, standard solutions, and standard samples. These changes will affect the specifications of 222 quasi-drug ingredients. Any comments can be submitted before October 14, 2024 via e-GOV.

Main revisions:

1. The proposal plans to modify the following parts of JSQI 2021:

No.	Content	No.	Content
1	2. Acrylonitrile test method	2	6. Anionic surfactants quantitative method
3	9. Ester value determination method	4	27. Perfume test method
5	40. Water-soluble collagen test method	6	47. Qualitative reaction
7	48. Iron test method	8	61. Non-saponifiable matter assay method
9	69. Methanol test method	10	75. Lipase titer test method
11	76. Sulfate test method	12	80. Standards
13	81. Reagents and test solutions	14	82. Standard solutions for volumetric analysis
15	83. Standard solutions

2. The proposal plans to revise the following standards and standard solutions:

Isopropylmethylphenol standard
Thioxolone standard
N-Lauroyl-N-Methyl-β-Aminopropionate standard
Formaldehyde standard solution

3. The proposal plans to change the following reagents and solutions

No.	Reagents/solutions	Status
1	Oxysulfate titanium test solution	20 new items added
2	Potassium permanganate solution
3	Dilute Earlich solution
4	Sulfuric acid, 26-27%
5	Acetic acid/sodium acetate buffer, pH 4.5, for iron testing, etc.
6	Isooctane	28 items revised
7	Orthotolidine solution
8	Strong‐acid cation exchanger
9	Silica gel solution
10	Pullulanase test solution, etc.
11	Arsenic trioxide (standard regent)	1 item deleted