분야별 정보자료/건강기능식품 개별인정 가이드라인

Summary of Individually Approved Health Functional Foods (HFF) – 1st Half of 2025

식품 및 건강기능식품 인허가 컨설팅 2025. 7. 28. 13:59

This document summarizes the deliberations by the Ministry of Food and Drug Safety (MFDS) in South Korea regarding the individually approved health functional food (HFF) materials from January to June 2025.

Overview of Deliberations

During the first half of 2025, MFDS held four deliberation sessions and reviewed a total of 58 applications for individual approval of health functional food materials. The outcomes are summarized as follows:

Outcome Number of Cases Percentage
Functional Efficacy Approved 40 67.8%
Standard/Specification Changes Approved 3 5.1%
Not Approved 10 16.9%
Supplement Request 5 8.5%

Key Observations

- Major reason for non-approval: Inadequate results from human application trials, highlighting the importance of meticulous test planning and oversight of conducting institutions.
- Supplement requests mainly related to insufficient evidence for functional efficacy, including the need for prior review of mechanisms of action and animal testing.

Breakdown of Functional Efficacy Approvals

The following table outlines the number of approvals and corresponding materials by function:

Functionality Number of
Approvals
Approved Materials
Body Fat Reduction 9 Fabifloral Ginger Root Extract, Fermented Schisandra Extract*, Lactiplantibacillus plantarum Probiotics, Roasted Citrus Peel Powder*, Moro Orange Powder, Whey Protein Hydrolysate, Black Cumin Powder*
Eye Health 5 Centella Asiatica Powder, Lutein-Zeaxanthin Complex, Maqui Berry Extract, T. lutea Powder
Skin Health 5 Low Molecular Deer Antler Collagen, Forthsign Placenta Peptide (PPP), Wheat Germ Extract*, Rose Petal Extract
Liver Health 3 Centella Asiatica Powder, Hovenia Dulcis Complex*
Menopausal Symptoms (Women) 2 Fermented Soy Germ, Fenugreek Extract
Sleep Health 2 Lime Peel Ethanol Extract, Lettuce Extract
Joint Health 2 Hyaluronic Acid, Boswellia Extract
Cholesterol Improvement 2 Korean Black Raspberry Extract, Policosanol from Sugarcane Wax
Respiratory Health 2 Ecklonia Extract Complex, Probiotics + Motherwort Extract Complex
Hair Health 2 Latilactobacillus curvatus LB-P9*
Men's Menopausal Symptoms 1 Gelatinized Maca Powder
Stomach Health 1 Gold Kiwi Lactic Acid Ferment
Gum Health 1 Propolis-Mangosteen Peel Complex
Cognitive Function 1 Probiotic Complex NVP-2106
Gut Health 1 Purslane Ethanol Extract Powder

* Joint Approval Cases: 6