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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, covering the following two parts:
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.
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