By Seongmin Sohn (Mike), CEO & Principal Consultant, Wynngate Korea CO., LTD.
Cosmetics regulation across Asia-Pacific is entering a new phase. For many years, regulatory compliance in the region was largely associated with product notification, ingredient restrictions, labelling, and market-specific administrative requirements. Today, the direction is increasingly moving toward evidence-based, pre-market safety management, with greater expectations around ingredient data, toxicological substantiation, exposure assessment and lifecycle responsibility.
South Korea prepares for a new safety assessment framework
South Korea is one of the clearest examples of this transition. Following the amendment of the Cosmetics Act in December 2025, Korea will introduce its cosmetic safety assessment system progressively from 2028. Responsible cosmetic sellers will be required to prepare safety assessment and documentation, which will then be reviewed by a qualified safety assessor and retain the relevant records. In June 2026, the Ministry of Food and Drug Safety also issued detailed guidance on preparing cosmetic safety assessment documentation. This represents an important structural change from a system primarily centred on compliance with ingredient standards and post-market controls toward a more proactive, product-specific safety assessment model. According to Seongmin (Mike) Sohn’s intel, the recent interpretation of the application range is likely to include all the current (~2027) + new (~2028) functional cosmetics marketed in Korea, which is a significant burden for the industry to comply.
For Korean companies, this should not be viewed simply as another domestic compliance burden. If implemented strategically, the new system can become an important foundation for global market access. Companies that begin building structured ingredient safety profiles, exposure assessments, toxicological rationales and product-level safety dossiers will be better positioned to adapt those data for markets such as the EU, UK and China rather than recreating regulatory evidence separately for every jurisdiction. K-Beauty’s dinosaur contract manufacturers are in serious preparation for the new regulation.
Japan strengthens its scientific approach to safety
Japan is moving in a similar scientific direction, although it is important to distinguish this from Korea’s legally defined 2028 model. Japan has not yet established an EU-style mandatory CPSR system for all cosmetics. However, the Japanese industry and regulators are increasingly formalising safety-assessment methodologies. The Japan Cosmetic Industry Association has developed safety-assessment and exposure-assessment guidance and continues to provide dedicated safety assessment training, while MHLW and PMDA have issued guidance covering areas such as skin penetration, irritation, acute toxicity, photo safety and, most recently, defined approaches for skin sensitisation. Japan is also actively participating in the ICCR safety-assessment workstream on New Approach Methodologies. These developments suggest that documented, scientifically structured safety assessment will become increasingly important even where the legal architecture differs from Europe or Korea.
China brings cosmetics and chemical regulation together
China presents an even more complex challenge because companies increasingly need to consider cosmetic regulation and chemical regulation in parallel. Under the NMPA framework, cosmetic ingredients are managed through the existing ingredient inventory, new cosmetic ingredient registration or filing, and increasingly detailed product safety assessment requirements. At the same time, a cosmetic ingredient may also fall within China’s environmental management regime for new chemical substances administered by the Ministry of Ecology and Environment. Therefore, confirmation that an ingredient is acceptable under the cosmetic framework does not necessarily resolve its status under China’s chemical substance inventory and registration system. Recent changes to China’s new chemical substance regime in 2026 make this cross-regulatory review even more important for innovative ingredients entering China.
Building regulatory readiness into product development
Another major trend is the rapid development of alternative methods and New Approach Methodologies, or NAMs. China has explicitly stated its intention to expand alternative methods and reduce reliance on animal testing, while developing approaches such as read-across and the Threshold of Toxicological Concern to address data gaps in complex ingredients including botanical extracts and fermentation-derived materials. Japan is advancing defined approaches for endpoints such as skin sensitisation, and international frameworks such as OECD guidance are increasingly incorporating QSAR, AOPs, omics technologies, high-throughput screening and mechanistic evidence into chemical assessment.
For industry, the implication is significant: regulatory readiness can no longer begin when a product is ready to launch. It must start at ingredient selection and product development. Companies should build reusable safety data packages covering ingredient identity, specifications, impurities, toxicological endpoints, exposure, data gaps and scientific justification, while ensuring that the evidence can be adapted to different regulatory frameworks.
The most competitive companies in APAC will therefore be those that move beyond country-by-country compliance and build a global safety-data architecture. Regulatory agility will increasingly depend not on knowing more regulations, but on generating, structuring and maintaining better scientific evidence.
Seongmin Sohn (Mike), CEO & Principal Consultant, Wynngate Korea CO., LTD., is speaking at the in-cosmetics Asia Marketing Trends Theatre 15:00-15:45 Thursday 5th November 2026 in the session ‘Latest Cosmetics Regulatory Updates and Compliance Strategies in EU, China, ASEAN, and South Korea.’ Visit the website to register to attend here.
ABOUT THE AUTHOR:
Seongmin (Mike) Sohn is a regulatory technical advisor at Wynngate Consulting, specializing in global cosmetics and chemical compliance. With over a decade of experience, he leads safety assessment strategies, international regulatory harmonization, and market-entry consulting across the U.S., EU, China, ASEAN, and Korea
