Introduction
On June 18, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea issued Announcement No.2025-277, proposing revisions to the current regulations governing the application and amendment requirements for New Food Additives under South Korea's regulation of the Temporary Standards and Specifications Criteria for Foods.
The revisions aim to accelerate innovation and market entry of new food additives, and bolster the development of the food industry, through new measures such as accepting internationally authoritative data, implementing tiered toxicity test requirements, and expanding the scope of safety-related amendments. Explore the main revisions.
Mutual Recognition of International Assessment Data to Avoid Duplicate Testing
The scope of recognized toxicity test data applicable to the safety assessment of new food additives will be expanded. Specifically, the evaluation reports issued by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) will be recognized as valid toxicity test data.
Establish a Tiered Toxicity Testing System with Risk-Based Requirements
To address excessive burdens from current toxicity data requirements, toxicity data requirements based on different scenarios are proposed, which can significantly reduce the testing demands:
General additives: A 90-day repeated dose toxicity test and genotoxicity test shall be conducted first. If harmful effects are identified in repeat dose toxicity test or genotoxicity test, or if the chemical structure of the additive indicates potential toxicity, additional tests such as reproductive and developmental toxicity test, immunotoxicity test, and carcinogenicity test shall be required.
Enzyme: Data on repeated dose toxicity, genotoxicity, and immunotoxicity (allergenicity) shall be submitted first, with supplementary data from other tests provided if necessary.
Flavorings: Data on repeated dose toxicity and genotoxicity shall be submitted first. For synthetic flavorings, classification of chemical structure shall also be provided.
Exemption Scenarios:
New substances that differ from approved additives only in salt form, or are isomers of approved food additives, may be exempted from toxicity tests if they can be proven to be substantially equivalent to approved additives in terms of chemical, biological, and toxicological properties.
⚠️ Note: For food additives derived from genetically modified (GM) microorganisms, South Korea requires the submission of information on GM microorganisms and related processes, as well as safety assessments.
Accelerate Approval Timelines for Scope-Expansion Applications
Adjustments to the formulation composition or proportion of additives under specific conditions—where such adjustments do not affect the safety of food additives—will be added to the list of eligible scenarios for change applications.
Previously, the scope of eligible change applications was limited to modifications such as updates to applicant-related information, changes to additive names or trade names, and other minor revisions.
In accordance with the timeline regulations for change applications outlined in the Temporary Standards and Specifications Criteria for Foods, South Korean authorities can complete the approval process for such applications in as few as 14 days.
REACH24H's Reminder for Food Enterprises Exporting to South Korea
The proposed revisions are currently open for the food industry’s feedback, with the public comment period ending on August 18, 2025.
South Korea is among the countries that require pre-market applications for new food additives/new food ingredients. Once these revisions take effect, the toxicity testing requirements for the application of new food additives will be significantly simplified, reducing both the costs and time associated with conducting tests for enterprises.
It will not only facilitate innovations among local South Korean food enterprises but also benefit international companies with multi-country market entry plans to access the South Korean market with accelerated movement.
If you have any questions in new food additives/new food ingredients, please feel free to contact our expert team at customer@reach24h.com.
