Food Supplement Registration in South Korea

Food Supplement Registration in South Korea

Food Supplement Registration in South Korea - Overview

Freyr Solutions facilitates the market entry of food businesses into South Korea by providing expert guidance on food product approval. We guide manufacturers through the food supplement registration process, ensuring compliance with the Ministry of Food and Drug Safety (MFDS). Our food Regulatory services will support every phase of dietary supplement marketing, encompassing critical aspects such as formula and labeling reviews, document preparations, and license submissions. We serve as your comprehensive partner, overseeing the process until your product is successfully imported and marketed in South Korea.

Food Product Classification +

  • 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).
  • As per South Korean 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.

Food Product Labeling +

Product Labeling in the Korean language on primary packages is required for both domestically produced and imported products.

Food Product Registration +

The key requirements for food supplement registration with the MFDS are:

  1. Business License:

A locally registered partner with a corresponding business license is necessary in order to register a Health Functional Food.

  1. Registration Type:

To import Health Functional Foods (HFFs), individuals must submit a declaration to the Korean Food and Drug Administration (KFDA) as per Article 8 of the Health Functional Food Act.

  1. Approval of Functional Ingredients:

According to Article 4 of the regulation, the food must meet two (02) criteria:

  1. Compliance with the Health Functional Food Act.
  2. Assurance of safety and functionality through scientific evidence.
  1. Result and Timeline:

The approval procedure for functional ingredients shall complete within 120 days from the date of application receipt.

Food Product Claims +

Article 16-1 of the Health Functional Food Act mandates FDA and industry deliberation for health claims on functional foods. Negative outcomes can be appealed within one (01) month. Authorized claims and conditions are listed in the Health Functional Food Code.


Food Supplement Registration in South Korea - Freyr Expertise

  • Food Supplement Classification (HFFs and Other 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.
Freyr Advantages


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).