[Updated] South Korea Modifies Health Functional Food Code

Updates: MFDS officially released the regulation on December 27, 2023.

On July 25, 2023, the Ministry of Food and Drug Safety (MFDS) published a notification¹ to solicit public opinion on the amendments to Health Functional Food Code. Consultation period is set to end on September 25, 2023.

Main proposed amendments include:

1. Modifying the precautions, specifications, and daily intake amounts of nine functional ingredient

The precautions for consumption, specifications, and daily intake amounts of nine functional ingredients, including Coenzyme Q10, Squalene, Conjugated Linolenic Acid, NAG, Oat Dietary Fiber, Inulin/Chicory Extract, Chitosan/Chitooligosaccharide, Garcinia Cambogia Extract, Aloe Gel, are to be revised following the latest re-evaluation results. Details are listed below:

No.

Functional ingredient

Proposed amendments

Coenzyme Q10

(코엔 자임Q10)

Precautions for consumption: (newly added)

- Nursing mothers should avoid consumption (수유부는 섭취를 피할 것

- Consult with an expert when taking anticoagulants (항응고제 복용 시 전문가와 상담할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Squalene

(스쿠알렌)

The requirement of vitamin A and D in the final product is deleted

Precautions for consumption: (newly added)

- Children, pregnant women, and nursing mothers should avoid consumption (어린이, 임산부 및 수유부는 섭취를 피할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Conjugated linolenic acid (공액리놀레산)

Specifications: (modified)

Lead (mg/kg): 3.0 or less ->1.0 or less

Cadmium (Cd) (mg/kg): 1.5 or less -> 0.3 or less

Precautions for consumption: (newly added)

- Children, pregnant women, and nursing mothers should avoid consumption (어린이, 임산부 및 수유부는 섭취를 피할 것)

- Individuals with liver disease should consult with an expert before consumption (간 질환이 있는 사람은 섭취 전 전문가와 상담할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

NAG

(N-아세틸 글루 코사민)

Precautions for consumption: (newly added)

- Children, pregnant women, and nursing mothers should avoid consumption (어린이, 임산부 및 수유부는 섭취를 피할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Oat dietary fiber

(귀리식이섬유)

Daily intake amount: (modified)

- May help improve blood cholesterol levels:

at least 3 g-> at least 4.5 g of oat dietary fiber

- May help suppress postprandial blood glucose levels:

at least 0.8 g-> 6.0 g of oat beta-glucan

· Precautions for consumption: (newly added)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Inulin/Chicory extract (이눌린/치커리추출물)

Precautions for consumption: (newly added)

- Pregnant women and nursing mothers should avoid consumption (어린이, 임산부 및 수유부는 섭취를 피할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Chitosan /chitooligosaccharide

(키토산/키토올리고당)

Specifications: (modified)

Lead (mg/kg): 3.0 or less -> 1.0 or less

Cadmium (mg/kg): 1.5 or less -> 0.3 or less

Daily intake amount: (modified)

- May help improve blood cholesterol levels: 1.2~4.5 g as chitosan /chitooligosaccharide -> 1.2~4.5 g as chitosan".

Precautions for consumption: (newly added)

- Children, pregnant women, and nursing mothers should avoid consumption (어린이, 임산부 및 수유부는 섭취를 피할 것)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

Garcinia Cambogia extract

(가르시니아캄보지아 추출물)

Daily intake amount: (modified)

Total amount of (-)-Hydroxycitric acid: “750 ~ 2,800 mg”-> “750 ~ 1,500 mg”

Precautions for consumption: (newly added)

- Men should avoid excessive consumption (남성의 경우 과다 섭취를 피할 것)

Aloe gel (알로에 겔)

Specification (modified)

The aloin content is modified as “the sum of aloin A and B shall be 10 or less mg/kg”

Daily intake amount

Total polyol content: “100 ~ 420 mg”-> “110 ~ 420 mg"

· Precautions for consumption: (newly added)

- In case of an adverse event, discontinue consumption and consult with an expert (이상사례 발생 시 섭취를 중단하고 전문가와 상담할 것)

2. Introducing a new product type of long-acting product

At present, if enterprises intend to manufacture health functional foods with disintegration properties, the only choice is manufacturing enteric product, i.e., delayed release product that can pass through the stomach without being broken down and disintegrates in the intestine.

MFDS plans to establish the definition and test methods for “long-acting product (지속성 제품)". Long-acting product refers to product with the property of being slowly dissolved compared to ordinary products. Water-soluble vitamins of vitamin B1, vitamin B2, niacin, pantothenic acid, vitamin B6, folic acid, vitamin B12, biotin, and vitamin C can be made as long-acting product.

The new product type can help decrease the consumption frequency of health functional food. For example, consumers can take one tablet of long-acting vitamin C instead of taking three pills of normal vitamin C. Besides, the authority expects enterprises to bring new technologies to product innovation.

3. Expanding the manufacturing standards for aloe vera gel, among other things.

Aloe gel is a noticed functional ingredient in South Korea. Currently, aloe gel can be manufactured only in dried and powdered forms. The authority proposes to modify the manufacturing standard of aloe gel material to allow it to be manufactured in the form of liquid and concentrates. By expanding the types of raw materials, the industry will be able to reduce the cost and time required for the powdering process and provide consumers with more diversified products.

More Information about Health Functional Food