The Ministry of Food and Drug Safety (MFDS) published the last version of Health Functional Food Code1 on February 17, 2023. The revisions were made based on the regular re-examination results of the notified functional materials, and the transition of individually recognized ingredients to notified ones. This regulation will come into effect on January 1, 2024.
As per the new version, the dietary supplements with Spirulina can no longer be claimed with "beneficial to skin health". The limits of heavy metal are intensified as well. The detailed modifications of the seven notified functional materials are compiled below:
No. | Functional Materials | Amendments |
1 | Chlorophyll-containing plants | Precaution (newly added) : |
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
2 | Spirulina | Specification (modified) |
- Lead (mg/kg): less than 3.0 -> less than 1.0 | ||
Daily intake (modified) | ||
(1) May help anti-oxidative activity: (total amount of Chlorophyll) 8 ∼150 mg -> 10∼80 mg | ||
(2) May help improve blood cholesterol: (total amount of Chlorophyll) 40∼150 mg -> 40∼80 mg | ||
Functional claims (modified): May help anti-oxidative activity and blood cholesterol improvement (항산화·혈중 콜레스테롤 개선에 도움을 줄 수 있음) (the function of helpful in skin health is deleted) | ||
Precaution (newly added): | ||
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
3 | Propolis extract | Specification (modified) |
- Lead (mg/kg): less than 5.0 -> less than 1.0 | ||
Daily intake (modified) | ||
- The total amount of flavonoid: 16~17 mg-> 20∼40 mg | ||
Precaution (newly added) | ||
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
4 | Gamma-Linolenic acid | Precaution (newly added) |
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
5 | Psyllium husk dietary fiber
| Daily intake (modified) |
(1) May help improve blood cholesterol: (total amount of Psyllium husk dietary fiber) more than 5.5g -> more than 6.0 g | ||
(2) May help facilitate bowel movements: (total amount of Psyllium husk dietary fiber) more than 3.9g ->more than 5.0 g | ||
Precaution (newly added) | ||
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
6 | Polydextrose | Precaution (newly added) |
Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) | ||
7 | Hongkuk | Precaution (newly added) |
- Children, pregnant women, and nursing women should not take the product. (어린이, 임산부 및 수유부는 섭취를 피할 것) | ||
- People who have liver disease or are taking hyperlipidemia medicines should not use the product (간 질환이 있거나, 고지혈증 치료제 복용 시 섭취를 피할 것) | ||
- Stop using the product and consult a healthcare professional if adverse events occur. (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것) |
Another key change in the new regulations is that the Coleus forskohlii extract (콜레우스포스콜리 추출물) is converted from an individually recognized ingredient to a notified functional ingredient. Coleus forskohlii extract's main efficacy is to help reduce body fat. After implementing the new regulation, any company can use Coleus forskohlii extract without pre-recognition. This change is expected to help more enterprises develop or import products added with this material.
Additionally, garlic is added with a new efficacy of “blood pressure control."
Background Functional materials not listed in the Health Functional Food Code cannot be used unless the enterprise received an approval for individually recognized ingredients from MFDS. The approval application is expensive and time costing. However, once the individually recognized ingredient is converted to a notified functional ingredient, the usage of the materials will no longer require a pre-recognition. According to the provisions in Health Functional Food Code, under certain circumstances, the individually recognized ingredient can be added into the regulation as a notified material. The circumstances include: (1) The functional ingredients recognized under the Regulation on Certification of Functional Ingredients and Specification2 can be added to the Code in case 6 years have passed from the date of recognition and more than 50 item manufacturing reports. (2) Adding health claim of functional ingredient, change of daily intake amount or preparation and/or processing by article 10 (2) of Regulation on Certification of Functional Ingredients and Specification2 can be added to the code in case 3 years have passed from the date of recognition (Except for the person who obtain the recognition intends to add the ingredient to the Code). |
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