Japan’s fluoride content regulations for toothpaste and mouthwash not harmonised with UK
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
- Food and drink
- Consumer and retail
- Healthcare services
Resolved
No
Date reported
23 June 2019
Last updated
17 December 2020
Public ID
PID-9M8MW9
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