South Korea’s Growing Health Functional Food Market and Ingredient Regulatory Framework

Health functional food market trends

In South Korea, health functional food refers to food produced in various formulations, such as tablets, capsules, and liquids, using ingredients that have functionalities useful for the human body. In recent years, the demand for health functional foods in South Korea has been steadily increasing. According to statistics from the Ministry of Food and Drug Safety (MFDS), domestic sales of health functional foods reached 3,768 billion KRW in 2023, while imports were valued at 1,395 billion KRW. From 2019 to 2023, the total market demand grew at a compound annual growth rate (CAGR) of 8.5%.

Among the most popular product categories, red ginseng, probiotics, vitamins and minerals, and EPA/DHA-containing oils dominate the market. In 2023, the domestic sales share of red ginseng, probiotics, and vitamins & minerals stood at 21.9%, 16.5%, and 13.7%, respectively. Similarly, imported health functional foods also saw strong demand for vitamins and minerals, probiotics, and EPA/DHA-containing oils. Notably, individually recognized functional ingredients accounted for nearly 15% of both domestic and imported products.

Regulatory oversight on functional ingredients

Regulation of functional ingredients is at the forefront of safety and quality control of health functional foods in South Korea. Under the Health Functional Food Act, functional ingredients in South Korea are classified into two types:

• Notified functional ingredients announced in the Health Functional Food Code with specified manufacturing methods and specifications;

• Individually recognized functional ingredients that are not listed in the Health Functional Food Code and require individual review and approval by the MFDS.

Notified functional ingredients

Notified functional ingredients are announced by the MFDS in the Health Functional Food Code with specific standards and specifications, and can be used by legal entities. Products manufactured using these ingredients, following the prescribed methods and standards, can be sold and imported without additional approval.

Currently, the list includes 28 nutrients and 69 functional raw materials. The MFDS periodically reviews and re-evaluates these ingredients based on factors such as reported adverse effects, long-term market presence, and other concerns that may impact their safety or functionalities. Based on review results, the MFDS may modify or revoke ingredient notifications. For enterprises planning to export health functional foods to South Korea, it is highly recommended to verify the latest list of notified ingredients to ensure compliance with local regulations.

Recommended reading

• [Updated] South Korea Modifies Health Functional Food Code (based on the 2022 re-evaluation results)

• South Korea Updates Standards and Specifications for Nine Health Functional Food Ingredients (based on the 2023 re-evaluation results)

• South Korea Announces 2024 Re-evaluation Results for Nine Health Functional Food Ingredients

Individually recognized functional ingredients

1. Scope of functional ingredient recognition

For ingredients not listed in the Health Functional Food Code, businesses must submit supporting documentation—including data on safety, functionality, and standards—for official recognition before manufacturing or importing such ingredients. It is important to note that only the applicant is permitted to use the recognized ingredient once approved.

Additionally, the requirement for ingredient recognition also applies in the following cases:

• Modifications to recognized ingredients: Any adjustments to functionality, intake amounts, manufacturing methods, specifications, or other factors that may affect the safety or functionality of an ingredient previously recognized under the Regulation on the Recognition of Functional Ingredients and Standards & Specifications for Health Functional Foods.

• Modification to existing notified functional ingredients: Any adjustments to functionality, intake amounts, manufacturing methods, specifications, or other factors that may affect the safety or functionality of an existing ingredient notified in the Health Functional Food Code. (In such cases, the newly recognized functional ingredient will be publicly notified in the Health Functional Food Code)

2. Application for functional ingredient recognition

To successfully obtain approval for functional ingredient recognition, the submission dossiers for MFDS review are of great significance. Businesses must submit an application letter to the MFDS, accompanied by the following materials:

1) Dossier

• A general summary of the dossier

• Data on origin, development history, and domestic/international recognition and usage status

• Data on manufacturing methods

• Data on the characteristics of the ingredient

• Data on the specification, test method, and test report of the functional components (or marker components)

• Data on specification, test method, and test report of hazardous substances

• Safety data

• Functionality data

• Data on intake method, consumption precautions, and relevant information on setting the items thereof

Notably, if the application concerns the addition or modification of specifications for a previously recognized ingredient, applicants may submit only the additional or revised materials, unless otherwise required by the MFDS.

2) Sample

3) Reference standards (functional components or marker components)

All submitted materials must include the original data. If documents are in a foreign language other than English, a Korean translation is required. The MFDS may require supplementation of data if necessary. For detailed submission guidelines, refer to the Regulation on the Recognition of Functional Ingredients and Standards & Specifications for Health Functional Foods.

3. Safety and functionality evaluation

Upon receiving the application, the MFDS will comprehensively examine the submitted materials in line with the criteria for matters including the origin, development history, domestic and international recognition and use status, manufacturing method, characteristics of the ingredients, traditional use, intake evaluation results, human application test results, and toxicity test results, and consult with the Health Functional Food Deliberation Committee (HFF committee) to ensure the safety and functionality of ingredients intended for recognition.

4. Recognition and certification

If the evaluation results are deemed suitable, the MFDS shall grant recognition, issue a certificate for the recognized functional ingredient, and disclose the ingredient information on MFDS website.

Specifically, about the recognition of ingredient functionality, if the submitted data provides strong scientific evidence supporting a reduction in disease risk, the ingredient functionality is classified under the disease risk reduction category, with approved claims like "May contribute to the reduction of XX disease risk occurrence". Meanwhile, if the submitted data demonstrates a special effect on normal bodily functions or biological activities, ingredient functionality falls under the physiologically effective function category, with approved claims like "May help to XX".  

5. Processing time

• Processing time for the recognition of new ingredients: Within 120 days from the date of receipt

• Processing time for the recognition of the addition or modification of specifications of a notified or previously recognized ingredient: Within 60 days from the date of receipt

6. Current recognition status in South Korea

As of 2024, South Korea has approved 800 cases of functional ingredient recognition. In 2024, 40 new cases were approved (see Table 1), a slight decline from 44 cases in 2023.

By application types, as of 2023, 334 cases were approved for new functional ingredients, while the rest 426 were additional applications for either modifications of previously notified or recognized ingredients or the use of recognized ingredients by new enterprises.

Table 1: Approved cases of functional ingredient recognition in 2024