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.
Background
Triheptanoin (CAS No. 620-67-7), is a synthetic triglyceride composed of three 7-carbon fatty acids (heptanoic acid) esterified with glycerol. In cosmetics, it is primarily used as an emollient and solvent.
On March 23, 2026, one Japan company obtained manufacturing and marketing approval for a pharmaceutical product containing Triheptanoin as the active ingredient under Article 14, Paragraph 1 of the PMDL, with the indication of LC-FAOD. On the same date, the MHLW issued a Director-General notification designating Triheptanoin as a pharmaceutical general name. Given that companies had previously submitted applications to include Triheptanoin in cosmetics, the MHLW issued this administrative notice to clarify the regulatory handling of cosmetics containing this ingredient.
Key Regulatory Requirements
Under the PMDL and the Japanese Standards for Cosmetics, substances that have been approved as active pharmaceutical ingredients are generally prohibited from use in cosmetics. The main points of this notice are as follows:
| Key Points | Details |
| Ingredient Classification | Triheptanoin is classified as a pharmaceutical ingredient under the PMDL |
| General Prohibition | Cosmetics containing triheptanoin are generally prohibited from manufacture and sale |
| Transitional Arrangements | Cosmetics that were already compliant prior to this notice may continue to be manufactured and sold |
| Legal Basis | Based on Article 14 of the PMDL and the Standards for Cosmetics provision prohibiting pharmaceutical ingredients in cosmetics |
Transitional Arrangements
The notice acknowledges that prior to its issuance, companies had already submitted and obtained approval for including Triheptanoin in cosmetics under the then-applicable regulations. To protect legitimate business interests and maintain market stability, a transitional arrangement has been established. Specifically, cosmetics that had completed regulatory filing or notification before April 20, 2026, and whose formulations and labeling complied with the regulations in effect at that time, are not subject to the new restrictions and may continue to be manufactured and sold.
Implications and Recommendations
It is recommended that relevant enterprises keep abreast of the supporting implementation rules, regulatory amendments and the expiration timeline of the transition period in a timely manner.
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