Ingredient guidelines: Korea rules vitamin C products to warn against overconsumption, kidney disease patients to consult doctors before use
The announcement also highlighted the need to display caution statements in HFF containing eight other raw materials, with most of the warnings pertaining to use amongst pregnant, breastfeeding women, and children.
The other eight raw materials affected are banana leaf extract, ginkgo leaf extract, octacosanol-containing oil, phosphatidylserine, guar gum / guar gum hydrolyzate, theanine, natto culture, and vitamin B6.
Vitamin C products should caution consumers to avoid overconsumption, with the daily intake amount unchanged at 30 to 1,000mg. Consumers with kidney disease are also advised to consult a specialist before consumption.
Vitamin B6 products would have to warn consumers to “stop taking and consult a specialist if tingling in hands and feet or adverse events such as burning, or numbness occur.”
Those containing banana leaf extract should display the statements “children, pregnant, and lactating women should avoid consumption” and “if adverse events occur, stop taking and consult a specialist”.
Products containing ginkgo leaf extract should also add the statement “consult a specialist when taking before and after surgery and medicine (anticoagulants).”
Aside from caution statements, the daily intake amount was also adjusted for some of the raw materials.
The daily intake of octacosanol, for instance, has been increased from a lower limit to seven mg to 10mg, with the upper limit of 40mg unchanged.
Guar gum, on the other hand, will need to contain more than 660mg/g of soluble dietary fibre instead of dietary fibre, and lead level of less than 1mg/kg instead of the previous 2mg/kg.
To make the claims “improvement of blood cholesterol”, “suppress postprandial blood sugar increase”, “may help facilitate bowel movements” and “could help beneficial bacteria proliferate in the intestines”, a product will need to contain guar gum or guar gum hydrolysate as dietary fibre of between five to 11 grams.
As for natto culture, the main change is in adjusting the total aflatoxin levels (sum of aflatoxins B1, B2, G1, G2) from 10μg/kg or less to 15 μg/kg or less, but that of aflatoxin B1 should be 10 μg/kg or less.
The safety profile of these raw materials was re-evaluated as part of a routine exercise by the MFDS on functional raw materials that have been allowed for use in the market for a decade, and also because some of them are linked to adverse events.
“The Ministry of Food and Drug Safety has been conducting a re-evaluation of functional health food ingredients every year since 2017,” the ministry said, adding that it has re-evaluated 64 raw materials until year 2022.
“The Ministry of Food and Drug Safety will continue to re-evaluate the safety and functionality of health functional foods based on the latest scientific literature and information, and reflect the results in the standards and specifications for health functional foods so that the public can use health functional foods with guaranteed safety and quality,” it said.
