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 6 or 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":
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:
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Note, MFDS also prohibited function claims related to:
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