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On March 5, 2025, the South Korea Ministry of Food and Drug Safety finalized amendments to the Health Functional Food Code, on the basis of 2023 re-evaluation results for nine health functional food ingredients. The amendments include revisions to functional ingredient manufacturing standards, specifications, daily intake limits, and precautionary statements.
Details are shown below.
(1) Revisions to functional ingredient specifications, daily intake limits, and precautionary statements
Article 3. 1. 1-10 Vitamin B6
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | Discontinue use and consult a professional if adverse effects occur, such as tingling, burning sensations, or numbness in the hands and feet. | / | January 1, 2026 |
Article 3.1.1-14 Vitamin C
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | l Avoid excessive intake. l Consult a professional before consumption if you have kidney disease. l Discontinue use and consult a professional if adverse effects occur. | / | January 1, 2026 |
Article 3.2.2-4 Chlorella
Item | Amended provision | Previous provision | Effective date |
Daily intake | l May help with antioxidant effects: 8–150 mg as total chlorophyll. l May help with immune enhancement, improving blood cholesterol levels, and skin health: 125–150 mg as total chlorophyll. | l May help with skin health and antioxidant effects: 8–150 mg as total chlorophyll. l May help with immune enhancement and improving blood cholesterol levels: 125–150 mg as total chlorophyll. | January 1, 2026 |
Article 3.2.2-12 Banaba Leaf Extract
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | l Children, pregnant women, and breastfeeding women should avoid consumption. l Discontinue use and consult a professional if adverse effects occur. | / | January 1, 2026 |
Article 3.2.2-13 Ginkgo Leaf Extract
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | l Children, pregnant women, and breastfeeding women should avoid consumption. l Consult a healthcare professional before and after surgery, or when taking medication (anticoagulants). l Discontinue use and consult a professional if adverse effects occur. | l Pregnant women, breastfeeding women, children, and patients before or after surgery should exercise caution when consuming. l Caution is also advised when taking medication (anticoagulants). | January 1, 2026 |
Article 3.2.2-22 Octacosanol-Containing Oil
Item | Amended provision | Previous provision | Effective date |
Daily intake | 10–40 mg as octacosanol | 7–40 mg as octacosanol | January 1, 2026 |
Precautions for consumption | l Children, pregnant women, and breastfeeding women should avoid consumption. l Discontinue use and consult a professional if adverse effects occur. | / | January 1, 2026 |
Article 3.2.2-29 Phosphatidylserine
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | l Pregnant women and breastfeeding women should avoid consumption. l Discontinue use and consult a professional if adverse effects occur. | l Pregnant and breastfeeding women should exercise caution when consuming. l Excessive intake may cause gastrointestinal discomfort or insomnia. | January 1, 2026 |
Article 3.2.2-33 Guar Gum/Guar Gum Hydrolysate
Item | Amended provision | Previous provision | Effective date |
Specification | Lead (mg/kg): 1.0 or below | Lead (mg/kg): 2.0 or below | January 1, 2026 |
Daily intake | 5–11 g as guar gum/guar gum hydrolysate dietary fiber | l May help improve blood cholesterol levels, suppress postprandial blood sugar spikes, and promote regular bowel movements: 9.9–27 g of guar gum/ guar gum hydrolysate dietary fiber. l May help promote the growth of beneficial gut bacteria: 4.6–27 g of guar gum/ guar gum hydrolysate dietary fiber. | January 1, 2026 |
Precautions for consumption | l Breastfeeding women should avoid consumption. l Must be consumed with sufficient water (except in liquid form). l Discontinue use and consult a professional if adverse effects occur. | Ensure adequate water intake when consuming (excluding liquid forms) | January 1, 2026 |
Article 3.2.2-54 Theanine
Item | Amended provision | Previous provision | Effective date |
Precautions for consumption | l Pregnant women and breastfeeding women should avoid consumption. l Be cautious when consuming with caffeine-containing beverages (e.g., coffee, black tea, green tea). l Consult a professional before and after surgery. l Discontinue use and consult a professional if adverse effects occur. | l Be cautious when consuming with caffeine-containing beverages (e.g., coffee, black tea, and green tea). l Pregnant women, breastfeeding women, children, and patients before or after surgery should exercise caution when consuming. | January 1, 2026 |
(2) Revisions to manufacturing standards of functional ingredients
Article 3.2.2-29 Phosphatidylserine
Item | Amended provision | Previous provision | Effective date |
Manufacturing method | The raw materials must be reacted with L-serine and the enzyme (phospholipase), then extracted and purified using water, ethanol (including water-ethanol mixtures), acetone, or hexane. | The raw materials must be reacted with L-serine and the enzyme (phospholipase), then extracted and purified using water, ethanol, acetone, or hexane. | Effective immediately |
Article 3.2.2-33 Guar Gum/Guar Gum Hydrolysate
Item | Amended provision | Previous provision | Effective date |
Content of functional (or marker) components | Must contain at least 660 mg/g of water-soluble dietary fiber | Must contain at least 660 mg/g of dietary fiber | January 1, 2026 |
Article 3.2.2-54 Theanine
Item | Amended provision | Previous provision | Effective date |
Raw material | (L-글루타민, 에틸아민) (b) L-glutamic acid, ethylamine (L-글루탐산, 에틸아민) | L-glutamine, ethylamine (L-글루타민, 에칠아민) | Effective immediately |
Manufacturing method | l The raw materials in (a) should be treated with glutaminase enzyme, reacted, purified, concentrated, and then crystallized using alcohol for manufacturing. l The raw materials in (b) should be reacted, purified, concentrated, and then crystallized using alcohol for manufacturing. l If the raw materials are chemically synthesized, they must comply with the standards and specifications for food additives. | l The raw materials should be reacted with glutaminase enzyme, then purified, concentrated, and crystallized using alcohol for manufacturing. l If the raw materials are chemically synthesized, they must comply with the standards and specifications for food additives. | Effective immediately |
This notification shall apply to health functional foods that are manufactured, processed, or imported (based on the date of shipment) after the enforcement of this notification. Health functional foods manufactured, processed, or imported before its enforcement may voluntarily comply with this notification.
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