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Korea Proposes Stricter GMP and Labeling Rules for Health Functional Foods
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South Korea's MFDS proposed amendments to the Health Functional Foods Act enforcement rules covering GMP standards for reprocessing, customized product labeling, and quality-test record integrity, with comments open until August 31, 2026.
What MFDS Proposed
On July 21, 2026, Korea's Ministry of Food and Drug Safety published draft amendments to the enforcement rules of the Health Functional Foods Act under Notice 2026-338. The proposal would establish GMP management standards for reprocessing, compressed air, and lubricants; require identifying markings on customized health functional food packaging and shelf-life plus 'not a drug' wording on inner packaging; and mandate use of record management systems intended to prevent falsification of quality test results.
The public comment period runs through August 31, 2026.
왜 중요한가
The changes target manufacturing and quality management for health functional foods, the Korean category that includes phosphatidylserine products such as WeBioM's claim-approved Doctor PS line. For ingredient suppliers selling into Korea, tighter GMP expectations around reprocessing, compressed air, lubricants, and test-record integrity would flow through to documentation required from raw material suppliers.
Trade coverage notes the revisions are part of a broader Korean effort to tighten GMP standards and labeling for customized health functional foods.
구매자 요약
Buyers preparing for Korean market entry should track the final rule and map their suppliers' GMP documentation to the proposed areas: reprocessing controls, compressed air and lubricant management, tamper-evident record systems, and customized-product labeling requirements.
A draft amendment is not yet law; Nutranexa reports the proposal as regulatory intelligence.