Health Functional Food Import Notification
Importing health functional food requires two steps: registering an imported food sales business with the Regional Ministry of Food and Drug Safety office, then filing an import notification for each shipment. Registration takes 3 days and costs KRW 28,000; inspection turnaround ranges from 2 days for document review to 10 days for laboratory testing.
How We Handle It
Determine Business Type
Identify which category applies — import and sales, notification agency, internet purchasing agency or storage (Special Act Art. 14(1)).
Hygiene Training
Complete the prescribed imported food hygiene training before starting the business (Art. 17(2)).
Business Registration
File Form 17 with the Regional MFDS office once facilities are in place. Three days, KRW 28,000.
Pre-Clearance Review
Check ingredient ratios, manufacturing method statement, conformity with health functional food standards and Korean labelling before customs to reduce rejection risk.
Import Notification
File Form 25 with the Regional MFDS office covering the clearance point, from 5 days before the expected arrival date.
Inspection
Undergo document review, on-site inspection, laboratory testing or random sampling per Annex 9.
Clearance
On a pass, the Form 28 import notification certificate is issued and the goods may be distributed after customs duties are paid.
Frequently Asked Questions
Q. Is this a notification or a registration?
A. Both, at different stages. Operating as an importer requires business registration with the Minister of Food and Drug Safety under Art. 15(1) of the Special Act on Imported Food Safety Control (filed in practice with the Regional MFDS office). Each physical shipment then requires an import notification under Art. 20(1).
Q. Where do I register the business?
A. With the Regional MFDS office covering your premises, using Form 17 (Enforcement Rule Art. 16(1)). It is the Regional MFDS office, not the district hygiene department. A registration certificate is issued on Form 18; storage businesses are inspected on site before registration.
Q. What is the processing time and fee?
A. Three days (Form 17). Fees: KRW 28,000 for registration, KRW 26,500 to change the premises address, KRW 9,300 for other registered particulars (free for a change of the operator’s name), KRW 5,300 to reissue the certificate and KRW 9,300 to report a succession of status.
Q. When is the import notification filed?
A. Form 25 is filed with the Regional MFDS office covering the customs clearance point, and may be filed up to 5 days before the expected arrival date. Any change to the declared port of arrival, expected arrival date or storage location must be reported in writing immediately (Enforcement Rule Art. 27(1)).
Q. How long does the import notification take?
A. It depends on the inspection type: 2 days for document review, 3 days for on-site inspection, 5 days for random sampling and 10 days for laboratory testing. Fungal count testing takes 10 days, irradiated food 14 days, and warm-storage testing 15 days (Form 25). Document supplementation or sampling schedules can extend this.
Q. What types of inspection are there?
A. Annex 9 of the Enforcement Rule defines four: document review of the filed paperwork; on-site inspection of the product’s condition, taste, odour, colour, labelling, packaging and testing history; laboratory testing by physical, chemical or microbiological methods; and random sampling under the MFDS sampling plan.