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

Taxus cuspidata can no longer be used as a food ingredient, even without drug efficacy claims.

Updated:

On December 27, 2022, MHLW added a supplementary amendment to amendment 1219, stating that there is a one-year transition for revisions to "Taxus cuspidata". Products can still be regulated according to the previous rules before December 19, 2023.

On December 19, 2022, Japan released an amendment to the Directory Distinguishing Food and Drug Ingredients. According to the amendment, MHLW further enriched the contents of the drug list (ingredients exclusively used as drugs). The changes came into effect on the date of promulgation.

Revisions:

  • Originally, when the extracted part of “Taxus cuspidata” is its fruit, it is possible to use it in food as long as it does not claim the efficacy of pharmaceuticals. However, the new list recorded all parts (branches, heartwood, leaves, fruits etc.) of it as ingredients exclusively used as drug.  

  • Newly added "N-phenyl propoxyphenyl carbodenafil" as an ingredient exclusively used as a medicine.

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. Enterprises are recommended to check whether the products contain ingredients classified as pharmaceutical ingredients before the exportation to Japan.

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