Ingredient Ban for Medicated Products in Japan

Do you remember? A couple of days back we discussed the Food and Drug Administration’s (FDA) final safety rule for antibacterial soaps. Following the US FDA’s call for the ban on specific ingredients, Japan turns the first implementation force in APAC announcing that they have implemented the ingredient ban already.

In an announcement, the Japanese Ministry of Health, Labour, and Welfare (MHLW) informed that they have eliminated the suggested ingredients from medicated products such as soaps, hand wash, shower gel and facial cleansing.

What caused the ban?

Earlier, the US FDA has released a final safety rule detailing the imposed ban on 19 ingredients which have been used for antibacterial soaps. Reasoning the manufacturer’s failure to submit necessary reports on the mentioned ingredients caused the proposed ban, the US FDA had given a clear-cut deadline of one year to put the ban in implementation. Decode the final safety rule and all you need to know here.

The list of banned ingredients includes the following:

  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodophors (Iodine-containing ingredients)

i)       Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)

ii)      Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)

iii)     Nonylphenoxypoly (ethyleneoxy) ethanoliodine

iv)     Poloxamer—iodine complex

v)      Povidone-iodine 5 to 10 percent

vi)     Undecoylium chloride iodine complex

  • Methylbenzethonium chloride
  • Phenol (greater than 1.5 percent
  • Phenol (less than 1.5 percent)
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triclocarban
  • Triclosan
  • Triple dye

With the reports stating that Triclosan and Triclocarban are the two commonly used ingredients across the Asia-Pacific region and the world over, Japan’s implementation sets a welcoming gesture for the ban, which of course is to emphasize the patient safety, at the outset. It is recommended antibacterial soap manufacturers across the world keep abreast with such Regulatory information for successful compliance and reduced time-to-market.