Korea’s MFDS Introduces In-Vitro Testing for Sunscreen Products

The Ministry of Food and Drug Safety (MFDS) has announced the introduction of in-vitro testing methods for sunscreen products, specifically for Sun Protection Factor (SPF) and PA ratings. This initiative, detailed in the draft amendments to the 'Regulations on Functional Cosmetics Review' and 'Regulations on Cosmetic Labeling and Advertising Evidence', was made public on August 19, with a call for feedback by September 18.

The reform aims to alleviate the burden and costs associated with human testing for companies, facilitating a faster response to the increasing overseas demand for sunscreen products. The move aligns with the growing influence of K-beauty in the global market, striving for harmonization with international standards to enhance domestic product development efficiency and export competitiveness.

Key elements of the amendment include the adoption of in-vitro testing methods that align with international standards, a differential scope for exempting application materials for functional reviews, and clear guidelines for the verification of SPF and PA advertising claims.

By implementing in-vitro testing based on international standards set by the International Organization for Standardization (ISO), specifically ISO 23675 and ISO 24443, the new guidelines expect to significantly reduce the time and costs involved in product development and evaluation. Companies will now have the option to use both human and in-vitro testing methods.

Previously, human testing took approximately one month and cost 6 million won, whereas in-vitro testing is expected to take only two days and cost around 3.5 million won. The new regulations also introduce a differentiated approach to the exemption of application materials for sunscreens with the same active ingredients, now considering the purpose and characteristics of additives used.

The criteria for advertising SPF claims will also be clarified; manufacturers will only be able to make claims based on scientifically validated results from either human or in-vitro tests. This change is expected to foster consumer trust through information grounded in scientific evidence.

The MFDS Commissioner, Oh Yu-kyung, stated, “The proactive adoption of international standard testing methods will enhance the efficiency of sunscreen development and secure a scientific evaluation basis. We will continue to refine our regulatory framework to support domestic companies in leveraging their excellent technology to enter the global market actively.”

Moreover, the MFDS plans to maintain regulatory innovation in alignment with international standards, contributing to a safe and reliable cosmetic distribution environment.

Details regarding the draft amendments can be accessed at the MFDS official website under 'Legislation/Data → Legal Information → Legislation/Administrative Notice'.