South Korea Streamlines Food Additive Application by Reducing Data Burden

On June 18, 2025, the Ministry of Food and Drug Safety (MFDS) in South Korea released the draft amendments of the Temporary Standards and Standards for Recognition of Standards for Food, etc. [1] (Administrative Notice No. 2025-277) for comments. This regulatory initiative was launched to support the development of food additives using new technologies by easing certain toxicology data requirements during the application for recognition of temporary standards and specifications of new food additives.

According to the draft, safety evaluation reports on food additives issued by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), e.g., toxicity data, may be recognized by MFDS, and thus, the applicant may not need to conduct new toxicity testing on the additives. This would significantly ease the burden on the food industry by reducing costs and time that is typically required to generate toxicity data. Moreover, MFDS would implement a stage-based toxicity data requirement. For instance, while repeated dose toxicity and genotoxicity data are typically required, additional, more extensive toxicity testing (e.g., reproductive toxicity testing and immunotoxicity testing) will only be required if there are safety concerns. In addition, after an additive is granted temporary recognition, the changes to the composition and mixing ratios of the food additive may be permitted without pre-approval so long as the quality of the approved additive remains unchanged.

These continued revisions of the food additive requirements by MFDS signal South Korea’s commitment to fostering a flexible regulatory environment to help support the food industry. South Korea in recent years has become more and more active in taking the lead of international collaboration on food regulations. For instance, back in March 2025, South Korea was re-appointed as the Chair Country of the third Asia-Pacific Food Regulatory Authority Summit (APFRAS) [2]. In May 2025, South Korea had a successful session with the Chinese government to discuss collaboration on a range of regulatory harmonization including food additive standards, food labeling, claims, pesticide residues, etc. [3]. Moreover, MFDS is a strong advocate of foods using new technologies, not only for food additives, but also novel foods such as cultured meat and fermentation-derived ingredients [4]. Therefore, when considering market-entry strategies into Asia Pacific, from a regulatory perspective, South Korea may be an attractive market to keep in mind.

Should you wish to learn more details about food additives or novel foods in South Korea, or other countries in the Asia Pacific region, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.

Keller and Heckman LLP represents the food industry on various regulatory matters. Please sign up for our newsletters here to keep up with the most recent developments.

[1] https://www.mfds.go.kr/brd/m_209/view.do?seq=44117
[2] https://www.fao.org/fao-who-codexalimentarius/news-and-events/news-details/en/c/1737821/
[3] https://www.cfsa.net.cn/zxdt/gzdt/2025/15244.shtml
[4] https://www.khlaw.com/insights/korea-releases-application-guidelines-cell-cultured-food#:~:text=Specifically%2C the guidelines review the,explanations of the data requirements