분야별 정보자료/식품·건강기능식품

MFDS Announces Proposed Amendment to “Standards and Specifications for Health Functional Foods” (July 23 Administrative Notice)

식품 및 건강기능식품 인허가 컨설팅 2025. 7. 23. 10:47

The Ministry of Food and Drug Safety (MFDS) announced on July 23 that it will issue an administrative notice for a partial amendment to the “Standards and Specifications for Health Functional Foods.” This amendment strengthens the standards and specifications for certain functional ingredients—such as Garcinia cambogia extract—and expands the list of permitted ingredients used to manufacture nutritional components like zinc in health functional foods.

This revision aims to support the development of Korea's health functional food industry by improving regulatory rationality while reinforcing safety management based on the results of functional ingredient re-evaluations.

Key Revisions:


① Strengthened Safety Precautions Based on Re-evaluation of Functional Ingredients

  • According to re-evaluation results, Garcinia cambogia extract, when taken with other fat-reducing ingredients such as green tea extract, may cause adverse effects.
  • Therefore, the amendment will:
    • Prohibit the combination of Garcinia cambogia extract with other fat-reducing functional ingredients during product manufacturing.
    • Include a new precaution advising consumers to avoid taking Garcinia cambogia extract along with other fat-reducing health functional foods.

② Regulatory Improvement: Expanded Use of Nutritional Ingredient Sources

  • The amendment will permit the use of internationally recognized ingredients—including those approved by Codex and other foreign authorities—as sources for nutritional components:
    • Zinc Citrate (구연산아연)
    • Ferric Saccharate (당산제이철)
  • This change is intended to enhance convenience for manufacturers and align domestic regulations with global standards.
  • Additionally, the functionality of “improving sleep quality” from hydrolyzed milk protein, previously available only through individual recognition (individual notification type), will now be included in the general notification list, making it available to all businesses and promoting industry growth.

③ New Specification for “Aloe Gel” Products

  • A new test specification for Aloe Gel, based on the iodine-starch reaction, will be established.

건강기능식품의+기준+및+규격+일부개정고시(안)(공고+제2025-318호,25.7.23.).pdf
0.34MB