On August 19, 2026, South Korea’s Ministry of Food and Drug Safety (MFDS) announces draft amendments to the Regulation on the Review of Functional Cosmetics and the Regulation on Substantiation of Labeling and Advertising of Cosmetics, with public comments due by September 18, 2026.
The draft amendments would newly introduce in vitro test methods for the determination of the sun protection factor (SPF) and the UVA protection grade (PA) of sunscreen cosmetics. CIRS Group has sorted out the main contents below for the reference of relevant companies.
Background
The amendments are intended to reduce companies’ human-testing burden and costs in developing sunscreen products, enabling them to respond quickly to surging overseas demand. As the influence of K-beauty continues to expand in the global market, South Korea seeks to improve the product development efficiency and global export competitiveness of domestic companies by aligning with international standards.
In vitro testing refers to a test method that measures UV protection using a PMMA (polymethyl methacrylate) plate instead of human skin. SPF (sun protection factor) is an index of UVB (290–320 nm) blocking efficacy, and PA is a grade of UVA (320–400 nm) blocking efficacy.
Main Contents of the Draft Amendments
1. Addition of Internationally Standardized In Vitro Test Methods
Under the current system, the SPF and PA of functional cosmetics for UV protection may only be determined through human application tests.
The draft amendments would incorporate into Korean national standards the in vitro test methods recognized by the International Organization for Standardization (ISO): ISO 23675 would be added for SPF determination, alongside the existing ISO 24444 (human test), and ISO 24443 would be added for PA determination, alongside the existing ISO 24442 (human test).
Companies will thus be able to conduct tests using automated testing equipment, dramatically reducing the time and cost of product development and evaluation.
2. Differentiated Management of the Scope of Data Exemptions in Functional Cosmetics Review
Under the current provisions, compared with a product that has already passed functional cosmetics review, an application may be partially exempted from the submission of review data as long as the ingredients representing the efficacy and effects (main ingredients) are identical in kind, specification and content (concentration for liquid formulations), directions for use and dosage, and formulation, regardless of differences in other additives.
The draft amendments would apply differentiated management to the scope of exemptions:
- partial exemption will be available only where the main ingredients and all additives such as A, B, C and D are identical;
- however, fragrances (flavoring agents), preservatives, and colorants whose content changes by less than 1% (limited to such changes and the resulting solvent changes, and not applicable to water-resistant products) are excluded from this requirement, meaning that differences in only such ingredients will not affect the data exemption.
MFDS stated that this measure aims to enhance the scientific validity of functional cosmetics review and further strengthen the safety and quality management of cosmetics.
3. Clarified Substantiation Standards for Sun Protection Index Labeling and Advertising
The current provisions do not specify the substantiation data standards for labeling and advertising claims regarding the UV protection efficacy of sunscreen products.
The draft amendments would add a new entry — “sun protection factor (SPF, including water resistance or very water resistance) and UVA protection grade (PA)” — to the annexed table of the Regulation on Substantiation of Labeling and Advertising of Cosmetics, clarifying that sun protection indices may be labeled or advertised only where data substantiated through human application tests or in vitro tests are submitted, and that the scope and requirements of the substantiation data follow Article 4(1), Article 5(1) and Article 6 of the Regulation on the Review of Functional Cosmetics.
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