Food and Dietary Supplement Registration in South Korea – Overview
Freyr Solutions assists food businesses in entering the South Korean market. With our Regulatory expertise, we guide manufacturers through the food supplement registration process, ensuring compliance with the Korea Ministry of Food and Drug Safety (MFDS). Our support covers all stages of dietary supplement marketing, including formula and labeling reviews, document preparations, and license submissions. We serve as your comprehensive partner, overseeing the process until your product is successfully imported and marketed in South Korea.
Food Product Classification
In South Korea, food items and dietary supplements fall under the Regulatory framework set by the Korea Ministry of Food and Drug Safety (MFDS). The classifications are defined as follows:
A. General Food Products
This category encompasses all food items meant for general consumption and is governed by the Food Sanitation Act. The categories include:
- Processed foods
- Beverages
- Frozen and refrigerated food items
- Meals that are ready to eat
- Condiments and seasonings
- Foods for infants and toddlers
B. Health Functional Foods (Dietary Supplements):
Health Functional Foods Korea (Dietary Supplements) Health Functional Foods (HFF) are overseen under the Health Functional Food Act. These are products that demonstrate scientifically validated health benefits and require approval from MFDS prior to being marketed. They typically include:
- Vitamins and minerals
- Probiotics
- Omega-3 fatty acids
- Ginseng and herbal extracts
- Functional proteins
- Supplements rich in antioxidants
Food Product Labeling
Labeling in the Korean language on primary packages is required for both domestic and imported products.
Food Product Registration South Korea
Business License
A locally registered partner with a corresponding business license must register a Health Functional Food Korea.
Registration Type
To import Health Functional Foods, individuals must submit a declaration to the Korean Food and Drug Administration (FDA) as per Article 8 of the Health Functional Food Act.
Approval of Functional Ingredients
According to Article 4 of the regulation, the food must meet two (02) criteria:
- Compliance with the Health Functional Food Act; and
- Assurance of safety and functionality through scientific evidence.
Result and Timeline
The approval procedure for functional ingredients will be completed within 120 days from the date of application receipt.
Food Product Claims
In South Korea MFDS categorizes claims into three types:
Nutrient Function Claims
These explain the role of nutrients in the body
- Calcium is essential for maintaining healthy bones
- Vitamin C aids in the absorption of iron
Health Function Claims
These claims need to be scientifically verified and receive MFDS approval, such as:
- Probiotics contribute to better gut health;
- Omega-3 may be beneficial for heart health.
Risk Reduction Claims
These statements imply that the intake of a food or supplement could lower the risk of disease, but they must be supported by robust scientific evidence and approved by the MFDS.
Any misleading or unauthorized claims, including those suggesting disease prevention, treatment, or cure, are expressly forbidden. Failing to comply can lead to Regulatory measures, including penalties or recalls of products.
How Freyr can help with South Korea food supplement registration
- Food Supplement Classification (HFFs and Foods)
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Health Claims Consulting (HFFs)
- Dossier Compilation, Review, and Submission
- Food Safety Risk Assessment
- Legal Representation (LR)
- Regulatory Intelligence (RI) Report
- Regulatory Strategy/Regulatory Pathway
- Import Guidance and Inspection Guidance
- Local Language Labeling Support
- Translation Support
- Food Product South Korea MFDS Compliance
Why Choose Freyr?
- Comprehensive Solutions
- End-to-end consultation for cosmetic import regulations in South Korea.
- Global Network
- Benefit from our strong partnerships and local connections.
- Cost-Effective Approach
- Structured processes for agile and efficient market entry.
- Market Expertise
- Extensive experience in skincare, haircare, infant care, oral care, and beauty products.
- Health Authority Relationships
- Leverage our rapport with South Korea Regulatory bodies for faster approvals.
- Regulatory South Korea MFDS compliance Excellence
- Expertise in formulation, labeling, and claims review ensures your products meet all standards.
Looking to expand into South Korea’s dynamic food and supplements market? Let’s make it a success together!
Frequently Asked Questions (FAQs)
We are here to provide you with the information you need quickly and efficiently
01. Who regulates food supplements in South Korea?
The Ministry of Food and Drug Safety (MFDS) is the primary Regulatory authority overseeing the registration and compliance of food supplements in South Korea.
02. How are food supplements classified in South Korea?
MFDS classifies food supplements as either general foods or Health-Functional Foods (HFFs) based on ingredients, function, and intended use.
03. Is Korean-language labeling mandatory for imported food supplements?
Yes. All food and supplement products sold in South Korea must have Korean-language labeling on the primary packaging.
04. What types of claims are allowed on food supplements?
MFDS permits pre-approved functional and nutrient claims. However, disease prevention, treatment, or cure claims are strictly prohibited.
05. Is pre-market approval required for food supplements in South Korea?
Yes. Depending on classification, pre-market approval or notification is required, especially for HFFs. Freyr supports dossier preparation and submission.
06. Do foreign manufacturers need a local representative?
Yes. Non-Korean entities must appoint a Legal Representative (LR) to interact with MFDS and manage local Regulatory responsibilities.
07. What documentation is needed for South Korea food supplement registration?
Key documents include formulation details, safety data, label mock-ups, claims substantiation, and import-related paperwork.
08. How does MFDS handle misleading advertising or labeling?
MFDS may penalize or recall products with non-compliant or misleading claims, especially if they are endorsed by healthcare professionals.
09. Can Freyr help with health claims substantiation?
Absolutely. Freyr offers scientific literature review and health claims consulting, ensuring your product claims are compliant and well-substantiated.
10. Why choose Freyr for South Korea market entry?
Freyr offers end-to-end Regulatory support, including classification, claims review, Korean labeling, local representation, and fast-track market entry—ensuring full compliance and smooth approvals.