In South Korea, Foods/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 Pills, Tablets, Capsules and Liquids. The Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & 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 MFDS (Ministry of Food and Drug Safety). Non-Listed Ingredients need the approval of MFDS (Ministry of Food and Drug Safety) through the review of Safety and Functionality of the Product. MFDS (ex-KFDA) has exclusive authority to give Pre-Market Approval. The Health Functional Food Code/the Food Additive Code establishes the standards and specifications for Manufacturing, Processing, Production, Import, Distribution, Storage, etc., of Health & Functional Foods for sale in South Korea. Labeling in Korean language on Primary Packages is required for both Domestic and Imported Products. Products intended for use to Enhance, Preserve & Benefit the Human Health with One or More Functional Ingredients (or) Constituents are defined as the "Health Functional Food (HFF)".
Freyr, with a proven Regulatory Expertise, assists Manufacturers right from Devising Regulatory Strategies to Submitting Applications to the MFDS to enter the South Korean market compliantly.
- Product Classification (HFF and Food)
- Formula Review/Ingredients Assessment
- Label and Claims Review
- Health Claims Consulting (HFF)
- Dossier Compilation, Review, and Submission
- Food Safety Risk Assessment
- Legal Representation
- Regulatory Intelligence Report
- Regulatory Strategy/ Regulatory Pathway
- Import Guidance and Inspection Guidance
- Local Language Labeling Support
- Translation Support
Expertise in local language labeling and translation services - Korean
Qualified team of experts with hands-on experience across all categories of foods like health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
Support for region-specific Regulatory activities
Extensive partner network across the globe
A strong relationship with various Health Authorities