Korean Health/Functional Food Legislation

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

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

Alkoxy-glycerol-containing product

Red yeast rice product

Octacosanol-containing product

Fructooligosaccharide-containing product

Lecithin product

Phytosterol-containing product

Embroyo bud product

Soy-protein-containing product

Embroy bud oil product

Green-tea-extract product

Gamma-linolecnic acid-containing product

Propolis-extract product

Spirulina product

Glucosamine-containing product

Chlorella product

Chitooligosacharide-containing product

Probiotics-containing product

Chitosan-containing product

Yeast-containing product

Beta-carotene product

Squalene-containing product

Soft-shelled-turtle product

Pollen product

Japanese apricot-extract product

Yeast product

Aloe product

Royal jelly product

Mushrooms product

EPA/DHA containing product

Chlorophyll-containing product

Eel oil product

Mucopolysaccharide product

Red ginseng product

Fermented vegetable-extract product

Ginseng product

Grape seed oil product

Nutritional supplement

 

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 using a two-step process related to two regulations: (1) evaluation of the safety and efficacy of the new ingredients, and (2) specification and analysis of the final product.

Documents that are required at each step for product-specific certification or new ingredient certification are listed below.

1. Standardization

a. Provide information on “special characteristics of functional ingredient (including yield and change in content of functional component)”

2. Safety evaluation

a. Provide information on “history of use, manufacturing processes, amount to be consumed, results of toxicity tests, results of human study, and results of nutritional evaluation and bio-availability”

b. Provide data showing scientific validation of safety of active ingredient

3. Efficacy evaluation

a. Provide data substantiating the functional food’s claim – “reliable scientific evidence”

b. When applying to certify the functional food ingredient as a generic functional food, the KFDA will perform its own efficacy trials

4. Specification

a. Provide sample final product

b. Provide “documentation on the method used to analyze the functional component and, if the decision is made to grant approval for the product as a health/functional food, confirm the period of conformity and hygiene specifications”.

Once certified, a functional food is allocated to one of four grades (see Table 2 as below) on the basis of scientific evidence, which in turn determines the level of the health claim a product may issue.

Table 2 Grades of health claims for health/functional foods

Scientific evidence

Claim allowed

Significant scientific agreement

Can help reduce the risk of (disease)

Convincing

Can have a beneficial effect on…

Probable

May improve…

Insufficient

May have possibility to improve…, but the evidence is limited and not conclusive

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.