News Details

On June 10, 2026, the South Korean Ministry of Food and Drug Safety (MFDS) announced the publication of the “Guideline for Preparing Cosmetic Safety Assessment Data” to support the implementation of a cosmetic safety assessment system. The guideline has been introduced to assist cosmetic businesses systematically prepare cosmetic safety assessment reports and product safety documentation. 

Purpose of the Guideline 

The guideline provides detailed instructions on collecting, documenting, and evaluating safety-related information, including product composition, physicochemical characteristics, and exposure assessments. The cosmetic safety assessment system is intended to demonstrate that cosmetic products are safe for human use under normal and reasonably foreseeable conditions. The system is scheduled to be implemented gradually from 2028. 

Background and Development Process 

To support cosmetic businesses, the MFDS has conducted a research project on cosmetic safety assessment reports since 2025. The guideline was finalized after gathering industry feedback in December 2025 and holding discussions with a public-private consultative body, involving cosmetic manufacturers, responsible distributors, related institutions and industry associations in June 2026. 

Key Components of the Safety Assessment Guideline 

The guideline outlines two major categories of safety assessment data. 

1. Cosmetic Safety Information 

This section includes quantitative and qualitative product composition, physicochemical properties and stability, microbiological quality, impurity and packaging information, product usage instructions, exposure assessments, Margin of Safety (MOS) evaluation, toxicological risk assessment, adverse event information, and other product-related details. 

2. Safety Assessment Conclusion and Safe Usage Measures 

This section contains the safety assessment review, the final safety conclusions and the precautionary statements for product use. 

Industry Response and Future Outlook 

An industry representative welcomed the guideline, stating that the introduction of a cosmetic safety assessment system aligned with global regulatory standards could strengthen K-Beauty exports. The MFDS expects the guideline to improve cosmetic safety management and consumer confidence in K-Beauty products. The ministry also plans to publish a detailed explanatory guide and casebook with practical examples by the end of 2026. Additionally, companies participating in the Cosmetic Safety Assessment Consulting Program, which has been accepting applications since April 2026, will receive the guideline and supporting materials free of charge.