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
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
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
Red yeast rice product
Embroyo bud product
Embroy bud oil product
Gamma-linolecnic acid-containing product
Japanese apricot-extract product
Royal jelly product
EPA/DHA containing product
Eel oil product
Red ginseng product
Fermented vegetable-extract product
Grape seed oil product
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:
Overall description of the prepared materials
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.
Materials related to its manufacturing method
Documents to explain the feature and quality of this active ingredient
Materials of the active ingredient’s specification, test method and test result
Specification, test method and test result of harmful substances
Materials to substantiate the safety
Materials to substantiate its functional efficacy
Documents related to the intake dosage, intake method, consumption precautions, etc.
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.
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
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
Up to Oct. 2019
Quantity of approved cases/received applications (pieces)
Approved ratio (%)
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
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
3. Information on nutrition and functionality
5. Sell by date
6. Storage condition
7. Name and address of manufacturing factory
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.