[Press Release, May 4, 2021 / Unofficial Translation]

□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) has announced that KeraSkinTM Skin Irritation Test (SIT), a locally developed alternative method to animal testing, was approved as an OECD Test Guideline (TG) in the 33rd Working Group of National Coordinators of the Test Guidelines Programme (WNT)*, which was held from April 20 to 23, 2021.

* Working Group of National Coordinators of the Test Guidelines Programme (WNT), represented by regulatory authorities of OECD member countries that adhere to Mutual Acceptance of Data (MAD), holds annual meetings to make decisions on TGs (i.e. approve and update TGs) and to decide on whether to include project proposals in the work plan.

○ KeraSkinTM SIT is a test method for evaluating skin irritation potential of chemicals based on the KeraSkinTM model.

- KeraSkinTM is a 3D-reconstructed human skin epidermis model that is manufactured with keratinocytes originating from the human foreskin, which is biochemically and morphologically similar to the human epidermis.

- KeraSkinTM SIT, developed as a research project of MFDS, was proposed as an OECD work plan following its validation study between 2018 and 2019 organized by KoCVAM*. The method was proven to be scientifically valid by the international peer review conducted between February and July in 2020.

* KoCVAM: Korean Center for the Validation of Alternative Methods

○ The WNT-approved OECD TGs will be officially endorsed at the joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology, which is scheduled for June. They are expected to be utilized in toxicity tests submitted to regulatory authorities of different countries.

□ Thanks to the recent approval, local GLP facilities and companies will be able to reduce the cost of skin irritation testing as they will be able to use the skin models that are domestically developed and manufactured, instead of relying on imported ones.

○ The MFDS will organize workshops and training sessions to help the domestic industry to widely utilize internationally approved alternative test methods, and will continuously work hard to facilitate the local development of alternative test methods and thereby promote their use.