Южнокорейский регулятор запускает повторную оценку десяти функциональных ингредиентов для пересмотра их безопасности и дозировок

The other eight ingredients earmarked for re-evaluation are milk protein extract, fingerroot extract powder, pumpkin seed extract complex, pine needle distillate concentrate, Pacran cranberry powder, Pu-erh tea extract, UREX probiotics and freeze-dried silkworm powder. Since 2017, the ministry has annually selected 10 functional ingredients that were approved and commercialized as Health Functional Food ingredients a decade earlier for re-evaluation. The aim is to reassess the safety and functionality of these ingredients in light of emerging evidence. Based on its findings, the regulator might adjust the permitted daily dosage, functional claims, introduce new precaution statements or remove functional claims entirely. As part of the re-evaluation process, manufacturers, sellers and holders of approvals for these functional ingredients must submit safety and efficacy data to the MFDS by the end of this year. Safety and efficacy data should meet the standards specified in the Regulation on Recognition of Functional Ingredients and Standards or Specifications for Health Functional Foods. Data submitted during the original approval review process need not be submitted during the re-evaluation process. Timeline The MFDS will run the re-evaluation process of the 10 ingredients from January to October next year, with a draft policy to be disclosed for public comments in November. Re-evaluation results will be published on the MFDS website next December. In South Korea, health functional food ingredients are categorized as individually approved or notified ingredients. Individually approved ingredients are new innovative ingredients developed by companies and are given exclusive rights to make specific functional claims once approved by the MFDS. Notified ingredients, on the other hand, have established health claims and daily intake levels already defined by the MFDS. For the upcoming re-evaluation, all ingredients, except bilberry extract, have been recognized as health functional ingredients via the individually approved pathway. Ingredients re-evaluated thus far Between 2017 and last year, the MFDS reviewed a total of 91 functional ingredients. Recently re-evaluated ingredients included green tea extract, shark liver oil containing alkoxyglycerol and kiwi extract in 2025, as well as primrose seed extract and guava leaf extract in 2024. Following re-evaluation, 90 ingredients have had their daily intake amounts or precaution statements adjusted. In 2022, whole aloe leaf was no longer recognized as a health functional ingredient due to adverse effects associated with liver toxicity, and reishi mushroom fruiting body extract was removed in June due to insufficient evidence of functionality. Others, such as Garcinia cambogia extract, can no longer be formulated into health functional foods alongside ingredients with similar body fat reduction properties. Manufacturers of Garcinia cambogia products would have to add the precautionary statement “avoid consumption with functional health foods that reduce body fat” in response to reports of adverse events, such as urticaria and abnormalities in the menstrual cycle. Spirulina, on the other hand, is no longer allowed to make skin health-related functional claims due to a lack of human clinical data, although it remains permitted for claims related to its antioxidative and blood cholesterol-lowering properties. This year, ingredients evaluated have included the probiotic Lactobacillus gasseri BNR17, mastic gum, boswellia extract, Spanish licorice extract, green coffee bean extract, lemon balm extract, hyaluronic acid and Rhodiola rosea extract. Three of these ingredients—turmeric extract, green coffee bean extract and lemon balm extract mixed powder—were selected not only as part of the routine re-evaluation but also because of their association with reported adverse events.