Administrative Notice of Partial Amendment to the Regulations on Recognition of Functional Ingredients and Standards and Specifications for Health Functional Foods (Notice No. 2026-406)

The Ministry of Food and Drug Safety announces the following under Article 46 of the Administrative Procedures Act to gather public opinions on the partial amendment to the ‘Regulations on Recognition of Functional Ingredients and Standards and Specifications for Health Functional Foods’ (MFDS Notice No. 2026-33, April 13, 2026).

1. Reason for amendment: To revise the fee fields in the application forms for functional ingredient recognition in accordance with the amended fees in the Enforcement Rules of the Health Functional Foods Act, and to improve the safety evaluation decision tree following the amendment of the definition of synthetic compounds in Article 2 of the Regulations.

2. Main contents:
a. Change of application forms (Attached Forms 1 and 2):
1) Revise the fee field in the ‘Application for Recognition of Functional Ingredient for Health Functional Foods’ due to the upward adjustment of review fees.
2) Revise the fee field in the ‘Application for Recognition of Health Functional Foods’ to distinguish between electronic and visit/mail applications.
b. Update of the safety evaluation decision tree (Attachment 3):
1) Improve the diagram to confirm ‘whether a synthetic compound not identical to a natural substance exists in nature and whether it can be used as a food or food additive’ in accordance with the revised definition of synthetic compounds in Article 2.

3. Submission of opinions: Any person or organization with opinions on the proposed amendment may submit a written opinion to the Commissioner of the MFDS by October 13, 2026, including:
a. Opinions on each item (with agreement/disagreement and reasons)
b. Name (or organization name and representative), address, and phone number
c. Other reference materials

Address: Food Standards Division, MFDS, Osong Health Technology Administration Complex, 187 Osongsaengmyeong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28159, Republic of Korea
Phone: 043-719-2443, Fax: 043-719-2400