MFDS to allow in vitro sunscreen testing, reducing burden of human studies

The Ministry of Food and Drug Safety will allow the use of test plates instead of human skin to evaluate sunscreens.

On the 19th, the MFDS issued advance notice of proposed amendments to the “Regulations on the Review of Functional Cosmetics” and the “Regulations on the Substantiation of Cosmetics Labeling and Advertising.” Comments will be accepted through Sept. 18.

The amendments are intended to improve the regulatory environment so companies can reduce the burden and cost of human studies during sunscreen development and respond quickly to overseas demand. They also aim to strengthen export competitiveness by aligning with international standards as K-beauty’s influence grows in global markets. Cosmetics exports increased from $8 billion in 2022 to $8.5 billion in 2023, $10.2 billion in 2024 and $11.4 billion in 2025.

The key change is the introduction of International Organization for Standardization (ISO) in vitro testing methods. In vitro testing evaluates ultraviolet protection using PMMA (polymethyl methacrylate) plates rather than human skin. SPF refers to the sun protection factor against ultraviolet B (UVB, 290~320 nm), while PA refers to the protection grade against ultraviolet A (UVA, 320~400 nm).

The MFDS will recognize ISO 23675 in addition to the existing ISO 24444 for SPF, and ISO 24443 in addition to the existing ISO 24442 for PA. After the amendments, both human and in vitro testing will be permitted, instead of only human studies under the current system. Automated testing equipment may also be used, reducing development and evaluation time and costs.

According to the MFDS, human testing costs 6 million won and takes about 1 month, while in vitro testing costs 3.5 million won and takes about 2 days. The agency said the changes could dramatically reduce the time and cost required for product development and evaluation.

The criteria for exemptions from submitting data for functional cosmetics reviews will also change. Under the current rules, partial exemptions are available when the active ingredients are the same, regardless of the excipients. Under the proposed amendments, the active ingredients and all excipients must be identical, except for flavoring agents, preservatives and colorants used at less than 1%, to qualify for a partial exemption. If only these three uses differ, the existing exemption will remain available. However, for water-resistant products, the exception for changes to colorants used at less than 1% will not apply, and safety and quality management will be strengthened by considering the purpose and characteristics of excipient use.

The amendments will clarify the substantiation criteria for SPF labeling and advertising, which previously lacked separate standards. SPF, water resistance or sustained water resistance, and PA may be labeled or advertised only when substantiated through human or in vitro testing. The MFDS expects this science-based information to increase consumer confidence.

Oh Yu-kyung, commissioner of the MFDS, said, “By proactively introducing international standard testing methods, we have improved the efficiency of sunscreen development and established a foundation for scientific evaluation. We will continue to improve the regulatory system in step with advances in new technologies and actively support domestic companies so they can enter global markets with their outstanding technological capabilities.”

The criteria for listing ingredients and quantities require that, for functional cosmetics other than those covered by Article 2, Items 4 and 5 of the Enforcement Rule of the Cosmetics Act, colorants, flavoring agents, suspending agents, emulsifying agents, solubilizers, stabilizers, tonicity agents, pH adjusters, viscosity adjusters and solvents for which no use limit has been specified be listed as appropriate quantities. The detailed proposed amendments are available on the MFDS’s official website.