South Korea’s Ministry of Food and Drug Safety (MFDS) has published its first official guideline for preparing cosmetic safety assessment dossiers, ahead of a phased mandatory safety evaluation system set to begin in 2028. The move signals tighter regulatory alignment with global standards, directly impacting OEM/ODM partners and exporters supplying the Korean beauty market.
Guideline scope and structure
The guideline outlines the required sections of a cosmetic safety assessment report, principles for completing each section, and methods for collecting and organizing safety data including product information, physicochemical properties, and exposure assessment. It is designed to help manufacturers and importers compile robust safety dossiers that meet both domestic and international benchmarks.
Industry consultation and timeline
MFDS began research on safety assessment report standards in 2025, gathered industry feedback in December 2025, and finalized the guideline through a public-private consultative body in June 2026. The phased introduction of the mandatory safety evaluation system will start in 2028, giving suppliers time to adapt their documentation processes.
Industry voice on global harmonization
Park Byung-joon, director at Kolmar Korea, who participated in the consultations, said: “We hope the introduction of a cosmetic safety assessment system harmonized with global regulations will support K-beauty exports. We ask MFDS to continue active cooperation with international regulatory bodies.”
What buyers should watch
Overseas buyers sourcing from Korean OEM/ODM manufacturers should note that from 2028 onward, finished products entering Korea will require compliant safety assessment dossiers. MFDS plans to release a detailed explanatory handbook and case studies by end of 2026. Companies enrolled in the ongoing ‘Cosmetic Safety Assessment Consulting’ program (open since April 2026) will receive the guideline and reference materials free of charge.
Sourcing context
The guideline is available on the MFDS website under the legal information section. For importers and distributors, early alignment with these requirements can reduce future compliance delays and strengthen product credibility in the Korean and broader Asian markets.
Source: Read the original report | Published: June 10, 2026