This barrier is unrelated to the end of the transition period, following the United Kingdom's departure from the EU.

Public ID: PID-9M8MW9

Japan’s fluoride content regulations for toothpaste and mouthwash not harmonised with UK

in Japan

Trade barrier summary

Mouthwash and toothpaste with fluoride content are currently not approved in Japan. Fluoride content in these products is considered a ‘quasi drug’. For toothpaste, this was resolved in 2017 when the maximum level was raised to 1,500ppm, the same as in the EU. For mouthwash, this was partly resolved.

Under current regulations, for product approval quasi drugs have to pass the following stages:
- drugs requiring pharmacist instruction become over the counter (OTC) after 1 year following approval
- OTC class 10 drugs move to class II or III after 1 year
- if there are no issues, after 3 years, OTC class III products are then approved as quasi drugs

Sectors affected

  • Consumer and retail
  • Food and drink
  • Healthcare services



Date reported

23 June 2019

Last updated

17 December 2020

Public ID


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