South Korean General Food with Function Claim

On January 21, 2021, MFDS issued the Q&As of General Food with Functional Labels ¹ as an interpretation to the regulation of Exceptions of Prohibited Labels and Advertisements of Food Functions ². This new regulation permitted the general food to label with the "function claims", which was only subject to "health functional food (dietary supplement)" before. The new provision will definitely open more opportunities to the food industry and benefit the general food companies.

ChemLinked will analyze the compliance issues, including the ingredient requirement, factory qualification, and labeling method, etc. We will also explore the market opportunities for overseas sellers.

1. Manufacture Requirements

1.1. Ingredient

Following the Exceptions of Prohibited Labels and Advertisements of Food Functions ², general foods using the specified functional ingredients can be promoted with function claims. The functional ingredients include:

1) Individually recognized functional ingredients

2) Twenty-nine noticed functional ingredients:

1. Ginseng

2. Red ginseng

3. Chlorella

4. Spirulina

5. Propolis extract

6. Guava leaf extract

7. Banana leaf extract

8. EPA, DHA oil

9. Plum extract

10.Guar gum/Hydrolyzed Guar gum

11. Fibersol-2

12. Soybean dietary fiber

13. Black mushroom dietary fiber

14. Wheat dietary fiber

15. Barley dietary fiber

16. Corn bran dietary fiber

17. Inlulin/chicory extract

18. Psyllium husk dietary fiber

19. Fenugreek dietary fiber

20. Aloe gel

21. Fructooligosaccharides

22. Probiotics

23. Red Yeast Rice

24. Soybean protein

25. Poly- -glutamic Acid

26. Garlic

27. Raffinose

28. Agar powder

29. Milk protein hydrolysate

The contents of the functional ingredients are required to exceed 30% of the recommended daily intake stipulated in Health Functional Food Code ⁴, whilst less than the maximum permissible contents.

Besides, if the enterprise uses the domestic functional ingredients in the "general food with function claims," the functional ingredients should be provided by factories in compliance with Health Functional Food Good Manufacturing Practice (GMP) ⁵. Nevertheless, if the product is manufactured with imported functional ingredients, the provider of the ingredients are not required with a GMP certification. (See 1.3. for more explanations.)

1.2. Factory Qualification

Factories proper for manufacturing the "general food with function claims" shall comply with HACCP standard under Food Sanitation Law ⁶or Livestock Products Sanitary Control Act ⁷. However, MFDS exempts foreign food facilities from the HACCP standard. In other words, as MFDS explained this provision in the Q&As of General Food with Functional Labels ¹, the overseas factories are eligible to produce "general food with function claims" as long as they finish the "foreign food facilities" registration. (How to register a foreign food facility? Check here ⁸.)

1.3. A Conclusion of the Requirements on the Final Product

Depending on the above requirements in 1.1. and 1.2., the three modes shown below are applicable for "general food with function claims":

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2. Labeling Requirement

2.1. Function Claims

The permitted scope of function claims shall be any of the following:

a. The efficacies of the twenty-nine noticed functional ingredients (MFDS has published all the permitted efficacies and the relevant recommended daily intake in Korean. Consult with the author if you need translation service);

b. The efficacies of the individually recognized functional ingredients;

c. The following efficacies with the scientific data:

Efficacies induced by replacing, reducing, or deleting a specific ingredient;
Efficacies about easing a hangover;
Efficacies about helpful in stomach or gut health.

Note, MFDS also prohibited function claims related to:

a. Beneficial to children, pregnant or lactating women, the elders, and other special consumers, such as "helpful in improving memory of the candidate for the college entrance examination," etc.;

b. Beneficial to sexual function or genital health;

c. Curing or preventing a disease.