Executive Summary

The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced on June 18, 2025, that it will make an administrative announcement of the revised "Standards for Temporary Standards and Specifications for Foods", which includes contents such as easing submission requirements when applying for temporary standard/specification recognition of new food additives.

The updated food additive regulations aim to streamline toxicity data requirements and approval procedures by recognizing international safety assessments and introducing phased testing and expedited modification pathways – reducing costs and aligning with global standards. Opinions on the revised (draft) can be submitted until August 18, 2025.

Key Regulatory Amendments

1. Enhanced Toxicity Data Submission Framework

The revised regulations introduce a more pragmatic approach to toxicity data requirements for new food additive applications. Under the previous framework, manufacturers and importers were required to submit comprehensive toxicity testing data from Good Laboratory Practice (GLP) certified facilities, including:

• Repeated dose toxicity testing
• Genotoxicity assessment
• Reproductive and developmental toxicity evaluation
• Immunotoxicity testing
• Carcinogenicity studies

New Submission Pathways:

International Safety Assessment Recognition: International safety assessment reports, such as those published by JECFA are now accepted as valid toxicity data, eliminating the need for duplicative testing when international evaluations already exist.

Phased Data Submission Protocol: A two-stage submission process has been implemented:

Stage 1: Primary toxicity evaluation (repeated dose toxicity and genotoxicity data)

→ Stage 2: Additional testing (reproductive toxicity, immunotoxicity, and carcinogenicity) only when scientifically warranted

This approach aligns with international regulatory harmonization efforts and reduces unnecessary testing costs while maintaining rigorous safety standards.

2. Streamlined Modification Procedures for Existing Temporary Standards

Current Limitations Addressed

Previously, any modification to ingredients or mixing ratios in approved temporary standards required complete re-application, including:

• Full toxicity data resubmission
• Application fees (30,000 KRW)
• Processing delays (approximately 180 days)

New Expedited Change Process

For modifications involving quality preservation additives (diluents, stabilizers) that do not impact safety profiles, the MFDS now offers:

• Accelerated approval timeline: 14 days maximum
• Fee waiver: No application costs for qualifying modifications
• Simplified documentation: Only change-specific materials required

This reform addresses industry concerns regarding operational efficiency while maintaining appropriate safety oversight.

Industry Impact and Benefits

Cost Reduction and Time Efficiency

The regulatory changes are expected to significantly reduce compliance costs and accelerate market entry for safe food additives. Industry stakeholders previously faced substantial financial burdens, with toxicity testing costs often exceeding hundreds of thousands of dollars per additive.

Enhanced Innovation Capacity

By accepting international assessment data and implementing phased testing protocols, these reforms enable companies to:

• Leverage existing international safety data
• Reduce duplicative testing requirements
• Accelerate product development cycles
• Focus resources on genuinely novel additives requiring comprehensive evaluation

Alignment with Global Standards

South Korea's food additive regulatory framework now more closely aligns with international practices, potentially facilitating trade and reducing barriers for multinational food companies

The MFDS plans to rationally improve and operate food additive standards and specifications so that safe and diverse food additives can be manufactured in the future.

Details can be found on the MFDS website, and opinions on the revised (draft) can be submitted until August 18, 2025.

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