Take home:
Japan MHLW revised its overall standards for raw ingredients used in quasi drug on Mar 30, 2017. The amendment mainly refers to general testing methods changing of some items and quality standard modification of several ingredients
This amendments of Standards will be effective on Sep 30th 2018, and before this date, there will a grace period.
Modifications in Part 1(generally about method):
|
No. |
Items |
|
1. |
Amine value measurement method |
|
2. |
Titanium Dioxide Determination Method |
|
3. |
PH testing method |
|
4. |
Arsenic testing method |
|
5. |
Vitamin A quantification method |
|
6. |
Powder X-ray diffraction testing method |
|
7. |
Methanol testing method |
|
8. |
Iodine value testing method |
|
9. |
filter Paper Chromatography |
|
10. |
Standard goods |
|
11. |
Testing drug& testing liquid |
|
12. |
Standard liquid for concentration analysis |
|
13. |
Standard liquid |
Modifications in Part2 (generally about form and quality change of ingredients)
|
No. |
Items |
|
1. |
Ethanol |
|
2. |
Ethanol 96 |
|
3. |
Hydrolyzed wheat protein solution |
|
4. |
Hydrolyzed wheat powder |
|
5. |
Retinol acetate |
|
6. |
Retinol palmitate |
|
7. |
Vitamin A oil |
|
8. |
Polyvinyl chloride dimethyl dimethylene pyrrolidinium solution |
|
9. |
Absolute ethanol |
|
10. |
Propylene glycol laurate |
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