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On January 7, 2025, the South Korea Ministry of Food and Drug Safety (MFDS) released the results of its re-evaluation on the safety and functionality of nine health functional food ingredients including soy isoflavone, guava leaf extract, evening primrose seed extract, lecithin, haematococcus extract, mucopolysaccharides-protein complex, reishi mushroom fruiting body extract, garcinia cambogia extract, and collagen peptides. The re-evaluation results will prompt updates to the Health Functional Food Code, which are scheduled to be announced by the MFDS in forthcoming administrative notices.
These ingredients were selected due to reported adverse effects, such as nausea, jaundice, elevated liver enzymes, vomiting, and indigestion, as well as the fact that some had been recognized for over a decade. The re-evaluation included a comprehensive review of original safety and functionality data, alongside new research and related information.
Below are the key updates:
Soy isoflavone
Daily intake limit: increased from 24–27 mg to 37–45 mg (as soy isoflavone aglycone)
Intake cautions:
Avoid consumption by infants, children, pregnant women, and nursing mothers.
Men should avoid excessive intake.
Individuals allergic to soy should exercise caution when consuming.
Individuals sensitive to estrogen hormones should exercise caution when consuming.
Discontinue consumption and consult a specialist if adverse effects occur.
Guava leaf extract
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Discontinue consumption and consult a specialist if adverse effects occur.
Evening primrose seed extract
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Discontinue consumption and consult a specialist if adverse effects occur.
Lecithin
Manufacturing standard: source materials updated from "soybeans, egg yolks" to "soybeans" (standards and specifications for egg yolks removed)
Limits of Lead (Pb): reduced from ≤2.0 mg/kg to ≤0.5 mg/kg.
Daily intake limit: revised from 1.2–18 g to 18 g
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Individuals allergic to soy should exercise caution when consuming this product.
Discontinue consumption and consult a specialist if adverse effects occur.
Haematococcus extract
Daily intake limit: revised from 4–12 mg to 6–12 mg
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Excessive intake may temporarily cause yellow discoloration of the skin.
May inhibit the absorption of β-carotene.
Discontinue consumption and consult a specialist if adverse effects occur.
Mucopolysaccharide-protein complex
Manufacturing standard: source materials narrowed to cartilage from pigs, chickens, and sharks (removal of cartilage from cows, sheep, deers, horses, rabbits, donkeys, poultry, squid, crabs, and shellfish)
Daily intake limit: increased from 1.2–1.5 g to 2 g
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Individuals with allergic tendencies may experience hypersensitivity reactions depending on personal conditions.
Discontinue consumption and consult a specialist if adverse effects occur.
Reishi mushroom fruiting body extract
Removed from the list of notified health functional food ingredients
Garcinia cambogia extract
Manufacturing standard: prohibited from being manufactured with other functional ingredients that have body fat reduction properties
Intake cautions:
Avoid consumption by children, pregnant women, and nursing mothers.
Men should avoid excessive intake.
Avoid consumption with health functional foods that claim body fat reduction functions.
Consult a specialist if you have liver, kidney, or heart diseases, allergies, asthma, or are taking medications.
Discontinue consumption and consult a specialist if adverse effects occur.
Collagen peptides
Intake cautions (shared by collagen peptides regardless of ingredient varieties):
Avoid consumption by infants, children, pregnant women, and nursing mothers.
Individuals with allergic tendencies may experience hypersensitivity reactions depending on personal conditions.
Discontinue consumption and consult a specialist if adverse effects occur
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