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On October 17, 2024, the Ministry of Food and Drug Safety (MFDS) announced the revised Regulations on Functional Claims or Advertisements of Foods That Are Not Considered Unfair (hereafter referred to as Regulation), specifying requirements for general food with functional claims supported by scientific backing through human application studies or systematic literature review.
In South Korea, permitted functional claims for general food are categorized into three types: a) functional claims associated with 29 noticed functional ingredients; b) functional claims associated with individually recognized functional ingredients; and c) functional claims supported by scientific backing through human application studies or systematic literature review. This Regulation introduces specific requirements for the third type.
Requirements for Functional Ingredients
Functional ingredients must meet validated content levels through clinical trials or align with the ingredient ratios of validated products.
Such ingredients must be processed in HACCP-certified or GMP-certified facilities. (imported food products excluded).
Final Product Specification
Products must contain at least 80% of the labeled functional ingredient content or follow the ingredient ratios of validated final products.
Labeling Requirements
Apart from the standard label requirements, general foods with functional claims supported by scientific data must label the following items. Items 1 and 5 must appear on the main display panel:
Specific validated functional claim.
Functional ingredient content (unless demonstrated at the product level).
Daily recommended intake.
Warning: "Excessive alcohol consumption harms health."(for hangover relief claims only)
Disclaimer: "This product is not a health functional food."
Statement that the product is not intended for disease prevention or treatment.
Instructions to discontinue use and consult a professional if adverse effects occur.
The Regulation will come into effect on January 1, 2025, except for Article 2 in Appendix 1, which takes effect immediately upon this announcement.
This Regulation applies to food products manufactured, processed, or imported for the first time (based on the shipment date) after the effective date. Products manufactured, processed, or imported before the effective date may voluntarily comply with the Regulation. Hangover relief products already manufactured, processed, or imported before the effective date may continue using previous labeling or advertising methods until their expiration.
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