Japan Updates Quasi Drugs Additives Positive List

The previous version of positive list of additives in quasi drugs was published on Mar 27 2008. In October 2016 Japan Ministry of Health, Labour and Welfare (MHLW) promulgated a revision to the list. The new list adds the following 9 ingredients with a total number of 2740 now:

Take home:

9 additives are newly permitted for use in quasi drugs.
2 existing additives are permitted for use in the category of other medicated cosmetics, bromhidrosis (body odor) treatment agents and dispersants.

The previous version of positive list of additives in quasi drugs was published on Mar 27 2008. In October 2016 Japan Ministry of Health, Labour and Welfare (MHLW) promulgated a revision to the list.

The new list adds the following 9 ingredients with a total number of 2740 now:

No.	Ingredients Name
337	Cetylpyridinium Chloride
515	Hydrolyzed Collagen Solution (4)
980	Dioctyl Ether
1118	Di(Isostearyl/Phytosteryl) Dilinoleate
1119	Di(phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl)Dilinoleate
1321	Dicaprylyl Carbonate
1748	Pimpinella Saxifraga Linne Extlact
1794	Placental Extract (3)
2642	Longan Seed Extract

The list also defines the usage condition and limits for the 9 ingredients (click here to find the usage condition and limits). In addition, two ingredients No. 113 Alkyl (8―16) Glucoside and NO.1993 PolyoxyethyleneCetyl / Stearyl Hydroxymyristylene Ether are now permitted to be used in the category of other medicated cosmetics, bromhidrosis treatment agent and dispersants but shall be under the limits of 10% and 2% respectively.

According to the Japan quasi drugs regulations, companies are recommended to use ingredients in the positive list and not exceeding the limits. If they use an ingredient outside the list or exceeding the limit, documents regarding its efficacy, safety, and ingredient formulation, purpose, etc. will require submission for review. Although there is a possibility that the application could be approved the review duration will be quite long.