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Japan Bans 19 Ingredients for Use in Medicated Soaps

Japanese Ministry of Health, Labour and Welfare (MHLW) announced the ban of 19 kinds of ingredients for use in medicated soaps including medicated hand wash, medicated shower gel and medicated facial cleansing.

Take home:

Japanese Ministry of Health, Labour and Welfare (MHLW) announced the ban of 19 kinds of ingredients for use in medicated soaps including medicated hand wash, medicated shower gel and medicated facial cleansing.

The 19 kinds of ingredients are:

No

Name

1

Cloflucarban

2

Fluorosalan

3

Hexachlorophene

4

Hexylresorcinol

5

Iodophors
(Iodine-containing ingredients)

Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)

6

Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)

7

Nonylphenoxypoly (ethyleneoxy) ethanoliodine

8

Poloxamer-iodine complex

9

Povidone-iodine 5-10 percent

10

Undecoylium chloride iodine complex

11

Methylbenzethonium chloride

12

Phenol (greater than 1.5 percent)

13

Phenol (less than 1.5 percent)

14

Secondary amyltricresols

15

Sodium oxychlorosene

16

Tribromsalan

17

Triclocarban

18

Triclosan

19

Triple dye

Medicated soaps are regulated as quasi drugs in Japan, which require registration with MHLW. For products already registered containing any one of the above 19 ingredients, if the ingredient functions as an active ingredient, a new application for registration shall be submitted before Sep 30 2017; if it is used as an additive, just an application for modification is needed before Sep 30 2017. To make the transition quick, MHLW released a policy that applications submitted during Nov 1 2016 to Sep 30 2017 will be subject to a quick review process under the condition that there is no error in the application form.

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