Japan Revises the Drug/Non-drug List for Food Ingredients

Two ingredients are added into the Non-drug List, which can be used as common food ingredients as long as they do not claim the efficacy and effect of pharmaceuticals. From October 23, 2023, products containing the ingredient dervied from Taxus yunnanensis's heartwood part will be directly judged as pharmaceuticals.

On October 24, 2022, Japan announced to revise the Directory Distinguishing Food and Drug Ingredients (hereinafter "the Directory"). In Japan, ingredients are the essential basis for classifying products as pharmaceuticals or foods. Competent authorities supervise the use of relevant ingredients through the Drug List and Non-drug List in the Directory.

According to the revision, six ingredients have been newly added into the Directory, two of them, namely Cynanchum wilfordii and (R)-3-Hydroxybutanoic acid can be used as common food ingredients as long as they do not claim medicinal efficacy. Besides, the alias of one ingredient named Pseudotaxus chienii in both lists was revised. Details are as follows:

Drug List

Source	Name	Alias	Part	Remark
Plants	インドハマユウ(Crinum latifolium)	Crinum latifolium Linn.	Whole plant	Newly added
Plants	コウトウスギ	• Taxus wallichiana • Taxus yunnanensis	Bark Leaf Heartwood	Newly added A one-year transition period was given to heartwood part. From October 23, 2023, products containing the ingredient dervied from heartwood part will be directly judged as pharmaceuticals.
Plants	ハクトウスギ	Pseudotaxus chienii	Bark Leaf	The alias was revised.
Animal	スイギュウカク	• Bubalus bubalis Linnaeus • Bubali cornu • Buffalo horn	Horn	Newly added
Others (chemical substances, etc.,)	ヒドロキシカルボデナフィル	Hydroxycarbodenafil	/	Newly added

Non-drug List

Source	Name	Alias	Part	Remark
Plant	コイケマ (Cynanchum wilfordii)	Cynanchum wilfordii	Tuberous root	Newly added
Plant	ハクトウスギ	Pseudotaxus chienii	Heartwood	The alias was revised.
Others (chemical substances, etc.)	D-β-ヒドロキシ酪酸	(R)-3-Hydroxybutanoic acid	/	Newly added

Notably, Pseudotaxus chienii was listed in both the Drug List and Non-drug List, but it can still be used as a common food ingredients if the part used is Heartwood.