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:
|
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. |
2.2. Labeling Requirements
Apart from the standard label requirements, the enterprises must add the below items on the main display side of the "general food with function claims."
Items on Main Display Side | Examples | |
1 | Phrases indicating the functional ingredient and the relevant efficacy | This product contains ginseng, which is well-known as helpful in improving immunity. (본 제품에는 면역력 증진에 도움을 줄 수 있다고 알려진 인삼 기능성 원재료가 들어 있습니다.) |
2 | Content of the functional ingredient | The total amount of ginsenoside Rg1 and Rb1: 50mg. (진세노사이드 Rg1과 Rb1의 합계로서 50 mg) |
3 | Recommended daily intake | The total amount of ginsenoside Rg1 and Rb1: 3∼80 mg. (진세노사이드 Rg1과 Rb1의 합계로서 3∼80 mg) |
4 | Precautions (can be exempted if no precautions of the functional ingredient have been decided) | Be aware of not taking it together with the medicines for diabetes or anti-coagulant. (의약품(당뇨치료제, 혈액항응고제) 복용 시 섭취에 주의) |
5 | Claims indicating the product is not a health functional product | This product is not a health functional food. (본 제품은 건강기능식품이 아닙니다.) |
Additionally, enterprises can present other items on the information display side or main display side:
This product is not a medicine to cure or prevent disease (질병의 예방·치료를 위한 제품이 아님).
Phrases suggesting a balanced diet (균형잡힌 식생활을 권장).
Stop taking and consult a health expert when experiencing side effects (이상사례가 있는 경우 섭취를 중지하고 전문가와 상담이 필요).
3. Opportunities and Challenges
More Korean citizens prefer healthy food as the increasing awareness of living healthily. The aging population also accelerates the growth of the health market. During Covid-19, the demand amongst Korean consumers for health functional foods blew up in popularity. According to Statista's report 9, the sales of health functional products skyrocketed by 579% from January 27 to February 11, 2020. The sales of vitamin products grew by over 2,000% compared to the previous year (See Figure 1).
(Figure 1. Sales of functional products from January 27 to February 11, source: Statista Research Department)
The "general food with function claims" can be expected as the next hot trend in South Korea. Compared with the pill or tablet formed dietary supplements, this general food formed product can be better accepted by the consumers. And it does help in promoting body functions containing functional ingredients. Moreover, as a general food after all, I predict it'd be cheaper than the health supplements.
Additionally, the import process of "general food with function claim" is much easier than that of the health functional food. Instead of the complicated and costly health functional food registration, the enterprises can claim their products as with health functions by submitting only two additional documents: a) the scientific data evidencing the functional ingredient is approved and b) test data of the functional contents in the final product during the import declaration. Other requirements of exporting the "general food with function claim" are the same as these of the general food. (Find more about the general food importation procedure here 10.)
The new provision also brings massive market opportunities to overseas functional ingredient providers. In South Korea, most general food factories don't meet the GMP standard. According to MFDS data 11, the registered enterprises conducting a food manufacturing business remained 50,131 in 2019. However, only 320 food manufacturers are designated as "GMP factories." Therefore, to manufacture the "general food with function claims", the enterprises need to either purchase the functional ingredients from a GMP factory in South Korea or import the functional ingredients from aboard. Considering the supplying capacity of the limited "GMP factories" in South Korea, overseas factories are suggested to seize this opportunity to export functional ingredients to South Korea. Moreover, as MFDS doesn't require the overseas producer to comply with GMP, the overseas functional ingredient producers would be more competitive.
ChemLinked would like to remind that the compliance requirement of the "general food with function claim" is not as complicated. What is significant is to apply for essential registrations, such as the foreign food facility, the individually recognized functional ingredients, etc. ChemLinked has helped numerous companies successfully access the South Korea market and contact us if you need assistance in trading with South Korea.
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