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  • Administrative Notice of Partial Revision (draft) to the Standards and Specifications of Health Functional Foods
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2024-07-12
    • Opinion Submission Deadline : 2024-09-10

1. Reason for revision

In accordance with Article 15-2 of the Health Functional Foods Act, revision aims to establish proper standards and specifications for functional health foods by strengthening the specifications of guar gum and guar gum hydrolysates, with reflection of the results of the reevaluation of the safety and functionality of seven kinds of functional raw materials, including banaba leaf extracts and two kinds of nutrients including Vitamin B6; by reestablishing the recommended daily intake amount of chlorella, oil/fat containing octacosanol, and guar gum/guar gum hydrolysates; by adding precautions regarding the intake of eight kinds of banaba leaf extracts; by expanding the methods of manufacturing phosphatidylserine; and by adding the raw materials of theanine.


2. Main contents

A. Revision of the precautions, specifications, and daily intake amounts of nine kinds of functional raw materials and nutritional ingredients, including banaba leaf extracts (Article 3. 1. 1-10 3), Article 3. 1. 1-14. 3), Article 3. 2. 2-4 3), Article 3. 2. 2-12 3), Article 3. 2. 2-13 3), Article 3. 2. 2-22. 3), Article 3. 2. 2-29 3), Article 3. 2. 2-33 1), 2) and 3), Article 3. 2. 2-54. 3) of the draft).

1) In accordance with Article 15-2 of the Health Functional Foods Act, the safety and functionality of accepted functional ingredients are re-evaluated at the latest scientific level.

2) The specifications of heavy metals in guar gum/guar gum hydrolysates are strengthened with reflection of results of the review of safety and functionality under “Reevaluation of functional raw materials of functional health foods,” daily intake amounts of chlorella, oil/fat containing octacosanol, and guar gum/guar gum hydrolysates are changed, and precautions regarding the intake of eight kinds, including banaba leaf extracts, are added or revised.

3) It aims to supply people with safe functional health foods by supplementing the standards and specifications of functional raw materials based on recent scientific evaluations.


B. Expansion of notified functional raw material manufacturing standards (Article 3. 2. 2-29 1), Article 3. 2. 2-54 1) of the draft) 

1) In order to revitalize functional health food products, it is required to add and notify manufacturing standards on notified raw materials. 

2) The method of extraction is expanded in phosphatidylserine manufacturing method, and theanine raw materials are added to expand the manufacturing method.

3) It is expected that the production and market of functional health foods will be revitalized due to the expansion of the notified raw material manufacturing standards.

Regulatory effect assessment
  • 건강기능식품의 기준 및 규격(규제영향분석서)_20240624.hwp [download]
Legislative proposal (draft)
  • 「건강기능식품의 기준 및 규격」일부개정고시(안)_.hwpx [download]