South Korea MFDS Simplifies New Food Additive Application & Testing

Mutual Recognition of Internationally Assessed Data to Avoid Duplicative Testing

The scope of toxicological test data that can be used for the safety assessment of new food additives has been expanded to recognize the contents of evaluation reports published by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) as valid toxicological test data.

Establishment of a Tiered Toxicological Testing Framework with Risk‑Based Requirements

It is recognized that the previous toxicological data requirements impose an excessively heavy burden on the industry. Accordingly, a differentiated approach to toxicological data requirements based on specific circumstances has been adopted, significantly reducing testing obligations:

For general food additives, a 90‑day repeated‑dose toxicity study and genotoxicity tests are required initially. If adverse effects are identified in these studies, or if the chemical structure of the additive suggests potential toxicity, additional tests, including reproductive and developmental toxicity, immunotoxicity, and carcinogenicity studies, shall be required.

For enzyme preparations, data on repeated‑dose toxicity, genotoxicity, and immunotoxicity (allergenicity) shall be submitted initially, with additional toxicological studies to be provided where necessary.

For flavoring substances, data on repeated‑dose toxicity and genotoxicity shall be submitted at the initial stage. For synthetic flavoring substances, classification information based on their chemical structure is additionally required.

Exemptions:

• For new substances that differ from an already approved food additive solely in the form of a salt;

• or for isomers of an already approved food additive, the toxicological test data requirements may be waived, provided that they can be demonstrated to be substantially equivalent to the approved additive in terms of chemical, biological, and toxicological properties.

Expansion of Scope for Application Changes and Accelerated Approval Timelines

Adjustments to the formulation composition or proportion of additives under specified conditions, where such adjustments do not compromise the safety of the food additive, are now included in the scope of amendable changes.

Previously, the scope of amendable changes was limited to changes in applicant information, changes in the additive name or trade name, and other minor changes.

Under the time limits for change applications prescribed in the Approval Standard of Temporary Standards and Specifications for Food, the Korean authorities can complete the review and approval of such applications within as little as 14 days.

Attention: Food Exporters to South Korea

South Korea is one of the countries that requires pre-market approval for new food additives and novel food ingredients. Now that the amendments have taken effect, the toxicological testing required for new food additive applications has been significantly reduced, thereby lowering the costs and time associated with such testing. This will not only facilitate innovation among domestic food companies in South Korea but also enable overseas companies with multi-market launch plans to enter the Korean market more expeditiously.

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