Overview

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 the 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 the Korean language on primary packages is required for both domestic and imported products. Products intended for use to enhance, preserve & benefit human health with one (01) or more functional ingredients (or) constituents are defined as "Health Functional Food (HFF)".

Freyr, with proven Regulatory Expertise, assists manufacturers right from devising Regulatory strategies to submitting applications to the MFDS to enter the South Korean market compliantly.