Food Compliance
Intelligence & Solutions
Home / News / Details

[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".

----------------------------------------------------------------------------------------------------------------------

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


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

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.

We provide full-scale Chinese food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by food@chemlinked.com
Copyright: unless otherwise stated all contents of this website are ©2021 - REACH24H Consulting Group - All Rights Reserved - For permission to use any content on this site, please contact cleditor@chemlinked.com