What Is Changing — The Draft Amendment to the Health Functional Foods Act Enforcement Rule
On July 21, 2026, Korea's Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Enforcement Rule of the Health Functional Foods Act. The public comment period closed on August 31, and the amendment is now awaiting promulgation. Its goal is to bring Korean health functional food (HFF) GMP in line with international benchmarks such as U.S. cGMP.
The amendment has three pillars:
Because this is still a draft, you should check the final wording, effective date and any grace period once the rule is officially promulgated. Separately, the already-finalized redesign of the HFF and GMP marks takes effect on January 1, 2028. These are two different timelines, so plan for them separately.
What Changes on the Shop Floor — Reprocessing, Compressed Air and Lubricants
Reprocessing
Reprocessing records will have to be kept. You'll need written criteria for when reprocessing is allowed, a QA approval step, and traceability that links each reprocessed lot back to its original lot.
Compressed air
Compressed air that touches product directly is treated as a potential source of cross-contamination and must be managed on a regular schedule. The key steps are setting filter replacement intervals and moisture and oil limits, then recording every check.
Lubricants
Food-grade lubricants must be used wherever product contact is possible, and you need to keep a list of where each lubricant is used along with its replacement history.
Items commonly missing from existing SOPs
The Biggest Task — A Tamper-Proof QC Record System
All QC results, including in-house self-testing, will have to be managed in a record management system. Paper test logs and Excel files will no longer be enough.
There are two main options:
Either way, the system must meet data integrity (ALCOA+) principles. Treat audit trails, role-based access control, electronic signatures and scheduled backups as non-negotiable. A practical approach is to decide how much instrument data (from HPLC and similar equipment) will flow in automatically, and to control any remaining manual entry with second-person verification and required reasons for every change.
Extra Steps for Personalized HFF Businesses
Readiness Roadmap for SME Manufacturers
Costs can be reduced by pairing this work with government programs such as the Smart Factory deployment initiative or quality-related support schemes. Whether LIMS or equipment upgrades qualify varies by call, so check each announcement.
How KITIM Can Help
KITIM supports HFF manufacturers with GMP gap assessments, SOP revisions, consulting on QC record system adoption, and applications for related government programs. If you'd like to settle your scope and budget before the rules take effect, request a consultation through KITIM's Contact page. One of our consultants will review your current setup and help you decide what to tackle first.