Japan Amends Standards of Quasi-drug Ingredients 2016

Last week Japan Ministry of Health, Labour and Welfare solicited public consultation on the amendments to Japanese Standards of Quasi-drug Ingredients 2016. The amendments are mainly related to quasi drugs’ testing methods.

1/ Chapter of General Testing Methods, including

No.	Content
1	3. Amine value determination method
2	19. Heat residue
3	47. Lead
4	51 Lead
5	53. Titanium dioxide quantification method
6	56. PH
7	58. Arsenic
8	59. Vitamin A quantification method
9	64. Powder X-ray diffractometry
10	68 Methanol
11	72. Iodine value determination method
12	76. Paper chromatography
13	78. Standard sample
14	79. Test drug, test solution
15	80. Standard solution for volume analysis
16	81. Standard solution

2/ Appendix II, including

No.	Content
1	Ethanol
2	Ethanol 96
3	Hydrolyzed Wheat Powder
4	Hydrolyzed Wheat Protein Solution
5	Retinol Acetate
6	Retinol Palmitate
7	Vitamin A Oil
8	Poly N,N’-Dimethyl-3,5-Methylene-Piperidinium Chloride Solution
9	Ethanol, Absolute
10	Propylene Glycol Monolaurate

The public consultation will end on July 12th 2016. According to the announcement the possible formal release date will be in April 2017 and there will be a grace period of one and a half years as of the implementation date.