Food and drug safety ministry proposes in-vitro sunscreen testing

The food and drug safety ministry said it proposed allowing in-vitro tests for sunscreen products, citing lower development burdens and a need to help domestic companies respond more quickly to growing overseas demand.

The ministry published the proposed revisions for administrative notice on Aug. 19 and will accept comments through Sept. 18.

Under the draft, companies could use in-vitro methods alongside human tests to assess sun protection factor, or SPF, and the UVA protection grade known as PA. The ministry would adopt International Organization for Standardization methods ISO 23675 and ISO 24443 as domestic standards. In-vitro testing uses polymethyl methacrylate plates instead of human skin and takes roughly two days and costs 3.5 million won, compared with about one month and 6 million won for human testing.

Only claims backed by human or in-vitro test data could carry SPF or PA figures on labels or in advertising. Current rules allow partial exemptions from review submissions when a sunscreen shares an active ingredient with a previously reviewed product, regardless of additives. The proposal would allow those exemptions only when the active ingredient and additives are the same, excluding fragrances, preservatives and colorants used at less than 1%.

"Early adoption of international standard test methods has increased the efficiency of sunscreen development and secured a foundation for scientific assessment," Oh Yu-kyung said. "We will continue to update the regulatory system in step with new technology and actively support domestic companies' expansion into global markets based on their technological capabilities."