This pedia is INVALID. Please refer to the new version: South Korea Health Functional Food (Dietary Supplement) Regulation 

1. Introduction

1.1 Definition

The term “health/functional foods” defined in the Korean Health/Functional Food Act refers to foods manufactured or processed with functional raw materials or ingredients useful for modification of physiological functions, maintenance of homeostasis or improvement of specific physiological parameters. The term “functionality” means utilizing nutrients to affect the physiological functions of the human body or providing useful effects for hygiene purposes including psychological benefits.

1.2 Relevant laws and regulations

• Food Hygiene Act

• Health/Functional Foods Act

• Enforcement Rule of Health/Functional Foods Act

• Health/Functional Food Code

• Regulation on Approval of Functional Ingredients for Health/Functional Foods

• Labeling Standard for Health/Functional Foods

• Regulations on Recognition of Raw Materials or Ingredients of Health/Functional Foods

• Regulations on Imported Health/Functional Food Notification and Inspection Procedure

• Prohibited Ingredients for Korea’s Health Functional Food

2. Classification of health/functional foods

Health/functional foods in Korea can be divided into two types of subcategories: generic and product-specific. The Health/functional Food Act references 37 generic health/functional food ingredients (see Table 1 as below). Product-specific health/functional food refer to all other products not included in the generic category. These products are required to be sold in measured doses (for example, pills, tablets, capsules and liquids). Products that are included in the established list of 37 generic health/functional foods do not require pre-market approval, whereas all new ingredients that are not considered as generic health/functional food must undergo pre-market evaluation by KFDA. In other countries, only the manufacturers need to get approval, while in Korea it is required that anyone selling health/functional food should get government approval.

Table 1 List of 37 Generic Functional Ingredients

Product-specific health/functional foods

If manufacturers or distributors want to market health/functional food that are not included in the list of generic health/functional food, they have to apply for approval as a product-specific health/functional food.

Before the official review, enterprises must submit following materials:

1. Overall description of the prepared materials

2. Materials related to the development background and the cause of products, recognition of the ingredient and the status quo of its application over domestic and overseas countries, etc.

3. Materials related to its manufacturing method

4. Documents to explain the feature and quality of this active ingredient

5. Materials of the active ingredient’s specification, test method and test result

6. Specification, test method and test result of harmful substances

7. Materials to substantiate the safety

8. Materials to substantiate its functional efficacy

9. Documents related to the intake dosage, intake method, consumption precautions, etc.

10. Materials to distinguish the product from medicines, etc.

After that, officials will start to conduct the review of its specification, safety, efficacy evaluation and specification.

1. Specification

In this part, the review will mainly focus on the feature of the ingredient, manufacturing technique, harmful substance, test method, etc.

2. Safety evaluation

When the ingredient is identified as a traditional used ingredient and its intake standard is similar with the referenced daily intake, then only the evidence for safe consumption, safety material and the amount to be consumed will be reviewed.

But once it is without the consumption history, the government will go through the safety material, the evidence for safe consumption, amount to be consumed, material of nutrition evaluation, human test result, toxicity test, etc.

3. Efficacy evaluation

The government will mainly review the research types, correlation, consistency, etc.

Consultation before Applying for the Novel Ingredient Approval

In South Korea, it has generally taken the government around 120 days to assess functional food ingredients and issue results (this step excludes time required to conduct safety review, etc.). However, if the scientific evidence supporting the application is deemed insufficient during the review the application is rejected, requiring applicants to start the whole process again. If we analyze the approved ration over the last five years, we will find although it keeps rising, it is still less than 50%.

Approval trend of novel active ingredient for health functional food

In order to help develop the health functional food industry, on Nov. 6th, 2019, MFDS released a guideline introducing a new consultation service to help enterprises expedite approval of functional foods.  

3. Health claims

Health claims approved for the product-specific health/functional food are currently categorized as follows:

Disease risk claim relate to reducing the risk factors associated with development of a disease or health-related conditions in the context of the total diet, requiring the highest level of scientific agreement. Claims about the use of health/functional food to prevent or cure specific diseases are not permitted.

The claims for the reduction of disease risk have only been approved for the reduction in dental caries associated with the use of xylitol.

Nutrient function claims relate to the modification of any physiological parameters associated with consumption of nutrients such as growth, development and normal functions of the human body.

Other function claims relate to any positive contribution to health or the improvement of a physiological function, or to modification or preservation of health in the context of the total diet. The following claims have been permitted on some products:

• Reduction of blood pressure

• Reduction of cholesterol

• Reduction of body fat

• Maintenance of good health

• Modulation of blood glucose level

• Modulation of postprandial glucose level

• Maintaining healthy gastrointestinal conditions

• Antioxidant effects

• Improvement of memory functions

• Improvement of cognitive functions

Conventional food or food supplemented with vitamins, minerals or nutrients are ineligible for the health claims.

4. Labeling requirements

Under the Health/functional Food Act, all food and agricultural imports must list the following information on their label in legible Korean. Health/functional foods in Korea must bear nutrition labeling.

1. Product name

2. Content

3. Information on nutrition and functionality

4. Ingredient

5. Sell by date

6. Storage condition

7. Name and address of manufacturing factory

8. Usage

9. Description on use and caution

Functional foods require the following additional information on their label:

1. Indication of functional food

2. Information on efficacy claim

3. Intake directions and cautions

4. Statement that product is not a pharmaceutical product that prevents or heals disease

5. Other points outlined in the detailed labeling guidelines for functional foods

The names of all ingredients have to be included on labels. In addition, food items considered as allergens (eggs, milk, peanuts, crab, tomatoes, etc.) must be indicated on the label in Korean, and all imported food products are required to be labeled with the necessary information in Korean. Stickers on packages are not permitted, and “made for purpose” manufacturer-printed Korean language labels must be used for health/functional food.