On April 20, 2026, the Pharmaceutical Safety and Environmental Health Bureau of the Japanese Ministry of Health, Labour and Welfare (MHLW) issued an administrative notice clarifying the regulatory treatment of cosmetics containing Triheptanoin. According to the notice, Triheptanoin has been classified as a pharmaceutical ingredient under the Pharmaceutical and Medical Device Act (PMDL), and cosmetics containing this ingredient are generally prohibited from manufacture and sale, though existing compliant products may continue to be sold during a transitional period.
The key details are as follows.
1) Ingredient Classification
- Triheptanoin is classified as a pharmaceutical ingredient under the PMDL.
2) General Prohibition
- Cosmetics containing triheptanoin are generally prohibited from manufacture and sale.
3) Transitional Arrangements
- Cosmetics that were already compliant prior to this notice may continue to be manufactured and sold.
4) Legal Basis
- Based on Article 14 of the PMDL and the Standards for Cosmetics provision prohibiting pharmaceutical ingredients in cosmetics.
Please refer to attached document below.
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