South Korea

Food Supplements Regulatory Support in South Korea

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, powder, flake, paste, and syrup. 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.

Food Classification

Category

Food Product classification

Regular Foods

Regular Foods & Conventional Foods (Bread, Beverages, Meat, Liquors, Sauces, etc.)

HFF (Health Functional Foods)
  1. Health Functional Foods (health functional claim): Vitamin & Mineral, Probiotics, Omega3, Lutein Supplement, etc., in the Health Functional Food Code.
  2. Individual Recognition HFF(IR-HFF): Individually recognized Health functional ingredients by MFDS (Ministry of Food and Drug Safety) approval. If you want to indicate the health functional claim or new active ingredient that does not exist in the health functional code, you must go to IR-HFF.(IR-HFF will be reviewed based on the standards and specifications, safety, clinical test & functionality assessment standards)

 

Food Registration

There is no typical registration procedure from the Ministry of Food and Drug Safety (MFDS). However, anyone who wants to register their foods in the KR market should notify their small amount of finished product to MFDS. Non-listed ingredients need the approval of MFDS through the review of safety, including toxicity in the foods. MFDS (ex-KFDA) has exclusive authority to give pre-market approval. The HFF 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.

Important Validities

Regarding foods and HFF for importation customs clearance, there is a regular timeline of fifteen (15) days from MFDS (Ministry of Food and Drug Safety). Typically, it will be completed within fifteen (15) days or depending on the situation, within thirty (30) days. Once the finished product is imported by MFDS, the validity is perpetual.

Freyr Expertise

  • Claims Consultation and Substantiation
  • Labeling Review
  • Claims Review
  • Dossier Compilation
  • Legal Representation Services
  • Food and Food Supplement Classification
  • Regulatory Intelligence Services
  • Food and Food Supplement Registration
  • Formula Review or Ingredient Assessment
  • Immunity Boosting Supplements
  • Novel Food and Novel Food Ingredient Registration

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