[Updated] Japan Approves the Amendment to Food and Drug Ingredients Distinguishing List

Japan MHLW proposes to add four ingredients into the list of substances that can be used as common food ingredients as long as they do not claim medicinal efficacy. Overseas food enterprises should check the product formula prior to exportation in case of the misuse of food ingredients.

On May 12, 2021, the MHLW officially approved the addition of Garcinia indic, Acmella oleracea, Diosgnein, Theacrine and the overground part of sesame into the appendix 2, and the alias of Rokuzyô is changed to“Cervus nippon, Cervus elaphus, Cervus canadensis and Cervidae".

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On March 1st, 2021, Japan released the proposed amendment to the “Directory Distinguishing Food and Drug Ingredients” (hereinafter “the directory”). Any comment shall be submitted before March 30.

There are two lists in the directory; one includes substances specialized for pharmaceuticals (appendix 1), the other lists ingredients that can be used as common food ingredients as long as they do not claim medicinal efficacy (appendix 2). According to the latest amendment, Japan authority is proposed to add four ingredients into appendix 2, which means that these four ingredients cannot be used in common food if they have any medicinal efficacy claims.

Here are the four ingredients newly included:

	Name	Alias	Part	Note
Substances originated in plants	Garcinia indic	India Garcinia mangostana/kobano mangostana/Kokum	Peel
Substances originated in plants	Acmella oleracea		Leaves, flowers, stems and leaves
Other substances (chemicals, vitamins and minerals, etc.)	Diosgnein	Diosgnein/Nitogenin/(3β,25R)-spirost-5-en-3-ol		Only non-glycoside
Other substances (chemicals, vitamins and minerals, etc.)	Theacrine	Theacrine/1,3,7,9-Tetramethyluric acid

In addition, the alias for Rokuzyô (included in Appendix 1) is changed from “Siberia deer/Manchu red deer/Manchu deer/wapiti” to “Cervus nippon, Cervus elaphus, Cervus canadensis and Cervidae”, the overground part of sesame (included in Appendix 2) can be used in common food as long as they do not claim medicinal efficacy.

Overseas enterprises should check whether pharmaceutical ingredients are used before exporting common food to Japan. If the ingredient is misused, the products will be deemed non-compliant and be rejected by Japan Customs. Besides, if the food ingredients are not included in any of the list (such as "food additive list), the manufacturers also need to consult their local Pharmaceutical Affairs Division.