Food Supplement Registration in South Korea

Food Supplement Registration in South Korea - Overview

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. The Ministry of Food and Drug Safety (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.

As per South Korea food regulations, Health Functional Foods (HFFs) are defined as products intended to enhance, preserve, and benefit human health with one (01) or more functional ingredients or constituents.

Freyr, with its proven Regulatory expertise, assists manufacturers for food supplement registration in South Korea, right from devising strategies to submitting applications to the Ministry of Food and Drug Safety (MFDS) so that their products can enter the South Korean market compliantly.

Food Supplement Registration in South Korea - Freyr Expertise

  • Food Supplement 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
  • Food Product Compliance.

Food Supplement Registration in South Korea - Freyr Advantages

  • Expertise in local language (Korean) labeling and translation services from Korean. End-to-end food Regulatory services.
  • 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).

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