Food Compliance
Intelligence & Solutions
Directory Distinguishing Food and Drug Ingredients
Local Title:
食薬区分における成分本質(原材料)の取扱いの例示
Country/Region:
Japan
Competent Authority:
Ministry of Health, Labour and Welfare
Type:
Standard
Status:
In force
Release Date:
2022-10-24
Implementation Date:
2022-10-24
Applicable Scope:
Aquatic & aquatic products; Alcoholic products; Bakery food; Beverage; Candy products; Condiment; Egg & egg products; Food additive; Food for special dietary uses; Frozen drinks; Fruits & vegetables; Grain & grain products; Health food; Infant formula food; Meat & meat products; Milk & milk products; Nutrition fortifier; Oil & oil products; Pet food; Others
Summary

The Directory is one of the important basis for Japanese authorities to supervise the use of ingredients, and mainly involves two lists. One includes ingredients that are considered as drugs (Drug List), the other lists ingredients not deemed drugs unless claiming medicinal efficacy (Non-drugs List). Before importing, enterprises can independently confirm whether the product contains pharmaceutical ingredients recognized by Japan through the Drug List and Non-drug List.

According to the latest 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. 

History
2023-02-17
In force
Release Date: 2023-02-17
Implementation Date : 2023-02-17
2022-12-19
In force
Release Date: 2022-12-19
Implementation Date : 2022-12-19
2022-10-24
Directory Distinguishing Food and Drug Ingredients
In force
Release Date: 2022-10-24
Implementation Date : 2022-10-24
2022-02-25
Invalid
Release Date: 2022-02-25
Implementation Date : 2022-02-25
2020-03-31
In force
Release Date: 2020-03-31
Implementation Date : 2020-03-21