Global 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:
2026-05-28
Implementation Date:
2026-05-28
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
Document
Language Source Title Access
JA
Official Directory Distinguishing Food and Drug Ingredients
Directory Distinguishing Food and Drug Ingredients
request
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, the MHLW added new substances to Drug List and Non-drug List and introduced a new "Scientific Name" column for plant-derived ingredients in Non-drug List.

History
2026-05-28
Directory Distinguishing Food and Drug Ingredients
In force
Release Date: 2026-05-28
Implementation Date : 2026-05-28
2025-06-30
Invalid
Release Date: 2025-06-30
Implementation Date : 2025-06-30
2025-03-28
Invalid
Release Date: 2025-03-28
Implementation Date : 2025-03-28
2024-10-17
Invalid
Release Date: 2024-10-17
Implementation Date : 2024-10-17
2023-02-17
Invalid
Release Date: 2023-02-17
Implementation Date : 2023-02-17
2022-12-19
Invalid
Release Date: 2022-12-19
Implementation Date : 2022-12-19
2022-10-24
Invalid
Release Date: 2022-10-24
Implementation Date : 2022-10-24
2022-02-25
Invalid
Release Date: 2022-02-25
Implementation Date : 2022-02-25
User Guide