South Korea Moves to Allow In Vitro Sunscreen Testing

The South Korean Ministry of Food and Drug Safety proposed allowing sunscreen manufacturers to use internationally recognized in vitro testing methods instead of testing exclusively on human skin. Proposed on September 18, the amendments would accept ISO 23675 for SPF and ISO 24443 for UVA protection. Alongside this testing shift, the ministry plans to amend Article 10 of the Enforcement Rule of the Cosmetics Act to narrow pre-market review exemptions. Under these tighter guidelines, exemptions will be limited to formulas nearly identical to previously approved products, with minor exceptions allowed only for fragrance, preservatives, and colorants used below 1%. For medical aesthetics clinics that retail or import K-beauty sunscreens, this transition, projected for 2026, offers a more ethical and internationally aligned standard for validating SPF claims. However, the strict pre-market review rules mean manufacturers cannot easily bypass scrutiny for minor ingredient changes. When planning your clinical retail inventory, expect highly reliable performance data from these imports, but prepare for slightly longer development timelines on brand-new formulations entering the market.

Source: The Monodist, https://themonodist.com/south-korea-moves-to-allow-in-vitro-spf-and-pa-testing-for-sunscreens/