Japan Regulatory Status
Regulatory Agency
No information available
Regulatory Category(ies)
No information available
Prebiotic Types
No information available
Fiber Definition
Food:
- Prebiotics are a long-standing ingredient category as functional substances in foods for special health uses (FOSHU)
- Various oligosaccharides, dietary fibers (e.g., indigestible dextrin, wheat bran, etc.)
- However, the demand for FOSHU is declining, with the trend shifting to Foods with Functional Claims (FFC)
- Unlike FOSHU, FFC allows for functional claims
Position on "Prebiotic Claim"
Food:
- From Cargill Japan: No official prebiotic regulation process
- Manufacturers need to check with authorities so as to not cross the line of pharmaceutical affairs law by using prebiotic wording on food labels
Rationale if not permitted (Include Reference / Regulation)
Not applicable
Facts Panel Declaration (per category)
No information available
Approved Health Claim(s)
No information available
Dose Specifics
No information available
Regulatory Submission
No information available
Claims Substantiation
No information available
Regulatory Approval Process
Food:
- FOSHU has a stricter approval process by which the government requires manufacturers to undertake efficacy and safety clinical trials
- FFC does not require a national permit, but rather the company’s evaluation. The FCC category relies on scientific evidence already available in the market
- FFC is much easier than EFSA; same concept as DSHEA
- However, it may take some time to get used to the documentation required for notification
Post-Approval Process (i.e., Amendment and Renewal)
No information available
Enforcement Practice
No information available
Link to Reference Documents
No information available
If you have updated information for this page, please submit it to Regulatory Lead Tania John for review: tjohn@nutrasource.ca. Thank you.