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 polymethyl methacrylate (PMMA) plate instead of human skin. The 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 that is predominantly used in Asia.
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 the in vitro test methods recognized by the International Organization for Standardization (ISO): ISO 23675 into Korean national standards 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 can 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.
What Can CIRS Do for You?
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, and R&D to data services across multiple industries.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards. We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
Our Services
- South Korea Cosmetics Product Notification & Registration (General Cosmetics, Functional Cosmetics)
- Quasi-drug Products Registration in South Korea
- South Korea Cosmetic Ingredient Database (KCID) Registration
- South Korea Responsible Party (RP) Services
- South Korea Cosmetic Formula Review
- South Korea Cosmetic Label Review
- Quality Inspection
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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