In South Korea, foods and health foods have a unique terminology and classification system. The Korean Health/Functional Food Act came into effect in January 2004 as a new Regulatory framework for ensuring the safety, efficacy, and labeling of Health Functional Foods (HFFs). The act requires HFFs to be marketed in measured doses, such as in the form of pills, tablets, capsules, and liquids. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food and Drug Administration (KFDA) is the governmental agency that regulates food, pharmaceuticals, medical devices, and cosmetics in South Korea.
Each product entering the South Korean market should be notified to the MFDS. Non-listed ingredients require the approval of the MFDS through a process of review of the safety and functionality of the product. MFDS has exclusive authority to give pre-market approval. The Health Functional Food Code/ Food Additive Code establishes the standards and specifications for the manufacture, processing, production, import, distribution, storage, and so on, of health and functional foods for sale in South Korea. Labeling in the Korean language on primary packages is required for both domestic and imported products.
In the context of South Korea, HFFs are defined as products intended to enhance, preserve, and benefit human health with one (01) or more functional ingredients or constituents are defined as.
Freyr, with its proven Regulatory expertise, assists manufacturers right from devising strategies to submitting applications to the MFDS so that their products can enter the South Korean market compliantly.
- Product 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
A qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, Health Functional Foods (HFFs), health functional beverages, Foods for Special Dietary Use (FSDU), etc.
Support in region-specific Regulatory activities
An extensive partnership network across the globe
A strong relationship with various Health Authorities (HAs)