South Korea Regulatory Status
Regulatory Agency
Ministry of Food and Drug Safety
Regulatory Category(ies)
Health Functional Food
Prebiotic Types
No information available
Fiber Definition
No information available
Position on "Prebiotic Claim"
- Regulatory framework classifies prebiotic ingredients as “Health Functional Foods”
- No reference to “prebiotic” made in any regulatory documents reviewed
Rationale if not permitted (Include Reference / Regulation)
For understanding South Korea’s system for functional food, please see the site below:
Health Functional Food Act: https://elaw.klri.re.kr/eng_service/lawView.do?hseq=34992&lang=ENG
Facts Panel Declaration (per category)
Conventional Food
Under an appropriate nutrient profile and based the ingredient such as fiber, sugar, etc.
Approved Health Claim(s)
Health Functional Food in Korea (khsa.or.kr)
- May help to maintain healthy gastrointestinal bacteria population
Dose Specifics
Prebiotic / Dietary Fibre:
- Guar Gum = 4.6 g – 27 g
- Fructooligosaccharide = 3 g – 8 g
Regulatory Submission
No information available
Claims Substantiation
No information available
Regulatory Approval Process
- Ingredients need to be approved individually by a company to be allowed as functional ingredient
- Regulation on Approval of Functional Ingredient for Health Functional Food, as follows:
- Provide information to support specification and standards, safety, and functionality
- 120-day review period
- Issued a Certificate of Functional Ingredient for Health Functional Food
Post-Approval Process (i.e., Amendment and Renewal)
Application of Modification on Certificate of Functional Ingredient for Health Functional Food
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.