The consultation is open until September 18, 2026.
For cosmetic manufacturers, the proposal could make sunscreen development more efficient by reducing reliance on human testing. It also brings Korean requirements closer to internationally recognized testing methods, an increasingly important consideration for companies developing products for both the domestic and export markets.
Why is South Korea changing its sunscreen testing rules?
Until now, the SPF and PA values of functional cosmetics intended to protect against UV radiation have generally been established through tests performed on human subjects.
The MFDS is now proposing to recognize laboratory-based, or in vitro, alternatives. Instead of measuring UV protection directly on human skin, these methods use a PMMA (polymethyl methacrylate) substrate to assess how effectively a sunscreen product absorbs or blocks ultraviolet radiation.
The distinction between the two main indicators is important. SPF primarily reflects protection against UVB radiation, generally in the 290–320 nm range, while PA is used to express protection against UVA radiation, approximately 320–400 nm.
The proposed change comes as South Korean cosmetics continue to expand internationally. By making product testing more efficient and aligning its framework with international standards, the MFDS aims to support faster product development and improve the competitiveness of Korean cosmetics companies in overseas markets.
International ISO methods would become part of the Korean framework
One of the most significant elements of the proposal is the addition of internationally standardized in vitro test methods to Korea’s regulatory framework.
For SPF, the MFDS proposes recognizing ISO 23675, which establishes an in vitro method for determining sunscreen protection. This would complement ISO 24444, the existing method based on human testing.
For UVA protection, the proposal would introduce ISO 24443 alongside the existing human testing method, ISO 24442.
This does not mean that human testing would disappear entirely. Rather, manufacturers would have additional testing routes available when generating the data needed to support sunscreen performance.
For companies, the practical impact could be significant. In vitro testing can be performed using standardized laboratory procedures and automated equipment, potentially reducing development time, operational complexity and the costs associated with recruiting and testing human volunteers.
A separate change would tighten exemptions in functional cosmetics reviews
The draft amendments also address another issue that is particularly relevant to manufacturers managing several products or variants within the same product family: the scope of data exemptions during the review of functional cosmetics.
Under the current approach, an applicant may qualify for a partial exemption from certain review data when the ingredients responsible for the product’s claimed function are the same as those in a previously reviewed product. The relevant characteristics include the type, specifications and concentration of the main ingredients, as well as the formulation and directions for use. Differences in other ingredients have not necessarily prevented an exemption.
The proposed system would make this assessment more specific.
In principle, the formulation would need to match not only in its functional or “main” ingredients but also in its other additives. However, the MFDS proposes limited flexibility for certain minor changes. Differences involving fragrances, preservatives or colorants of less than 1% would generally not prevent the exemption, provided the change falls within the conditions set out in the proposal. Corresponding solvent changes resulting from these modifications would also be covered.
This exception would not apply to water-resistant products.
The purpose is to make sure that an exemption from supporting data remains scientifically justified while avoiding unnecessary duplication of regulatory work for relatively minor formulation changes.
For manufacturers, the message is clear: even small formulation modifications may need to be assessed carefully when determining whether existing functional-cosmetic review data can still be relied upon.
Sun-protection claims would also receive clearer substantiation rules
The proposal addresses not only how SPF and PA are measured, but also how these values can be used in cosmetic labeling and advertising.
The current rules do not provide the same level of detail on the evidence required to substantiate UV protection claims. The proposed amendments would add SPF and PA to the relevant substantiation framework, including claims relating to water resistance and very water resistance.
Under the proposed system, manufacturers wishing to communicate these sun-protection indices on packaging or in advertising would need supporting data generated through an accepted human or in vitro test method.
The requirements for this evidence would be linked directly to the provisions governing the review of functional cosmetics. In practice, this would create a clearer connection between the testing method used by a manufacturer, the regulatory review of the product and the claims ultimately communicated to consumers.
What does this mean for cosmetic businesses?
For companies developing sunscreens for the Korean market, the proposal is worth watching closely.
The possible introduction of ISO-based in vitro testing could provide manufacturers with greater flexibility during product development and reduce some of the practical burden associated with human testing. At the same time, the proposed changes to data exemptions show that MFDS is also moving toward more detailed control of formulation differences and supporting evidence.
For companies entering the Korean market—or using Korea as a base for international cosmetic development—the broader trend is particularly relevant. Regulatory systems are increasingly incorporating standardized laboratory methods while placing greater emphasis on the scientific quality and traceability of the evidence behind cosmetic claims.
The proposals are not yet final requirements. Companies affected by the changes should therefore distinguish between the current regulatory framework and the rules that may apply if the amendments are adopted following the public consultation.
The consultation period runs until September 18, 2026, after which the MFDS will consider the submitted comments before deciding on the final provisions.
