South Korea to Ease Data Requirements for New Food Additive Recognition

On June 18, 2025, the South Korea Ministry of Food and Drug Safety consulted on draft amendments to the Standards for Recognition of Temporary Standards and Specifications for Foods. These proposed changes aim to refine the requirements for the temporary recognition of new food additives, thereby reducing the regulatory burden on businesses. Stakeholders are encouraged to submit opinions by August 18, 2025.

Key proposed amendments are summarized below

Expansion of Acceptable Toxicological Test Data

The draft expands the acceptable range of toxicological test data for the safety evaluation of new food additives to include evaluation reports from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) as recognized toxicity test data.

Amendments to Toxicological Data Requirements Based on Different Circumstances

Requirements in Current Regulation	Requirements in the Draft
In general, toxicological test data must include Repeated-dose toxicity test (90-day) Genotoxicity test Reproductive & developmental toxicity test Immunotoxicity test Carcinogenicity test	In general, toxicological test data shall include Repeated-dose toxicity test (90-day) Genotoxicity test If adverse reactions related to the food additive are observed, or if further safety confirmation is needed due to its chemical structure or other factors, additional data from reproductive & developmental toxicity test, immunotoxicity test, and carcinogenicity test may be requested.
Specific cases (specified data must be submitted, and additional data may be requested if necessary)
Processing aid (excluding enzymes): Repeated-dose toxicity genotoxicity test data	/(Removed from specific cases)
Enzyme: Repeated-dose toxicity test Genotoxicity test Immunotoxicity (allergenicity) test	No changes
Flavoring agent: Repeated-dose toxicity test Genotoxicity test Chemical structure classification (for synthetic flavorings only)	No changes
Additive is a component generally present in food, or if it is easily degraded or digested into components generally present in food(scientific evidence must be provide): Repeated-dose toxicity tests Genotoxicity tests	/(Removed from specific cases)
Food additive differs only in salt form or is an isomer of an already established food additive: Repeated-dose toxicity test Genotoxicity test If evidence is provided that it acts identically in chemical, biological, and toxicological properties to the already approved additive, the toxicity data may be omitted.	For food additive differs only in salt form or is an isomer of an already established food additive, if evidence is provided that it acts identically in chemical, biological, and toxicological properties to the already approved additive, the toxicity data may be omitted.

Expanded Scope for Modification of Temporary Standards and Specifications

Under current regulations, application for modification can only be made for changes to representative, company name and manufacturer, location, raw material name, or other minor matters that do not affect safety. The draft stipulates that modifications to the component or mixing ratio (%) may be allowed when substances such as diluents or stabilizers are added solely for the purposes of quality preservation, without impacting the safety of the product. As the standard processing time for such modifications is 14 days (compared to 180 days for new applications), this change will significantly improve efficiency for businesses.