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  • Administrative Pre-announcement of Partial Amendment to the Regulations on the Reassessment of Functional Ingredients, etc.
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2023-11-24
    • Opinion Submission Deadline : 2024-01-23

1. Reasons for Amendment

This Amendment clarifies provisions to allow cancellation when not all functionality is recognized in a reassessment pursuant to Article 15-2 (Reassessment) of the Health Functional Foods Act. It also modifies and streamlines wording for easier understanding of reassessment criteria, comprehensive evaluations, etc.



2. Major Provisions


A. Amend provisions to allow cancellation when not all functionality is recognized in a reassessment (attached Table 1) 

1) Paragraph 1 of Article 15-2 (Reassessment) of the Health Functional Foods Act allows matters that have been publicly notified or recognized to be altered or canceled based on the results of reassessment.


2) The current provisions allow functionality to be canceled only when “functionality information has been confirmed false.”


3) Accordingly, this Amendment clarifies the provisions to allow cancellation of functional ingredients when not all functionality information is recognized in a reassessment.

Regulatory effect assessment
  • 기능성 원료 등의 재평가 실시에 관한 규정(규제영향분석서)_20231110.hwp [download]
Legislative proposal (draft)
  • ?기능성 원료 등의 재평가 실시에 관한 규정? 일부개정고시(안).hwpx [download]