Food Supplement Registration South Korea
Freyr Solutions assists food businesses in entering the South Korean market. With our Regulatory expertise, we guide manufacturers through the food supplement registration process in South Korea, ensuring compliance with the Ministry of Food and Drug Safety (MFDS). Our support covers all Food and dietary supplement marketing stages, 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
Food items and dietary supplements regulations in South Korea fall under the Ministry of Food and Drug Safety (MFDS) Regulatory framework. The classifications are defined as follows:
A. General Food Products
This category encompasses all food items 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 (HFF) registration in South Korea 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 Registration
Business License
A locally registered partner with a corresponding business license must register a Health Functional Food.
Registration Type
To import South Korea Health Functional Foods compliance, individuals must submit a declaration to the Korean Food and Drug Administration (FDA) 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 and Food Supplements South Korea Product Claims
In South Korea, MFDS dietary supplement regulations categorize claims into three (03) 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 food or supplement intake 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 forbidden. Failing to comply can lead to Regulatory measures, including penalties or product recalls.
Food and Food Supplement Registration South Korea - Freyr Expertise
Why Choose Freyr?
- Comprehensive Solutions
- End-to-end consultation for Food and Food Supplement import regulations in South Korea.
- Global Network
- Benefit from our strong partnerships and local connections.
- Cost-Effective Approach
- Structured processes for agile and efficient Korean Health Food market entry.
- Market Expertise
- Extensive experience in skincare, haircare, infant care, oral care, and beauty products.
- Health Authority Relationships
- Leverage our rapport with South Korean Regulatory bodies for faster approvals.
- Regulatory Compliance South Korea Excellence
- Expertise in formulation, labeling, and claims review ensures your products meet all standards.
Are you looking to expand into South Korea’s dynamic Food and Food Supplements market? Let’s make it a success together!