Table of Contents
- What Are Health Functional Foods?
- Types of Businesses
- MFDS Registration Requirements
- Labeling Requirements
- Import Procedure
- Required Documents
- FAQ
1. What Are Health Functional Foods?
Health functional foods (건강기능식품) are products with scientifically proven health benefits beyond basic nutrition. In Korea, they are strictly regulated by the Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under the Health Functional Food Act.
2. Types of Businesses
- Manufacturer (제조업): produces health functional foods — requires GMP facility certification
- Importer/Responsible Distributor (수입판매업): imports and sells — requires MFDS product notification/approval per product
- Sales business (판매업): sells domestically manufactured or approved imported products
3. MFDS Registration Requirements
- Business registration with MFDS before selling
- For manufacturers: GMP certification of the production facility
- For importers: each product batch must pass import inspection
- Functional ingredient claims must be pre-approved by MFDS
4. Labeling Requirements
- Korean label required for all products sold in Korea
- Must include: product name, ingredients, functional claims (MFDS-approved text only), serving size, expiry date, manufacturer/importer info
- Unapproved health claims are prohibited and can result in product seizure
5. Import Procedure
- Obtain MFDS product notification or approval before first import
- Each import shipment goes through Customs and MFDS import inspection
- Apply Korean labels before distribution
- Maintain batch records for 3 years minimum
6. Required Documents
- Health functional food business registration application
- Business registration certificate
- Product specification sheet
- Certificate of Analysis (for each batch)
- Country of origin documentation
- MFDS product notification or approval certificate
FAQ
Q. Can I sell imported health functional foods on Korean e-commerce platforms?
A. Yes, but each product must have MFDS approval or notification, Korean labeling, and the business must be registered as a health functional food sales business.
Q. Are dietary supplements the same as health functional foods in Korea?
A. Not necessarily. Only products officially classified as 건강기능식품 by MFDS can make functional claims. Ordinary supplements sold without MFDS classification cannot make health benefit claims.
Register Your Health Functional Food Business
Vision Administrative Office handles MFDS registration and compliance for health functional food businesses. Free initial consultation.
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