Acceptance of Episkin Model in China Facing an Uphill Struggle

L’oreal’s subsidiary company, Shanghai Episkin Biotecknology Ltd. was granted a business license by State Administration for Industry & Commerce of China (SAICC). The company will promote and sell its reconstructed skin model Episkin in China. The Chinese Episkin model is a human epidermis model reconstructed from Asian keratinocytes, produced by the L’Oréal Advanced Research laboratories in China according to the same production standard and quality control criteria as at L’Oréal’s Predictive Evaluation Center in Gerland, France.

The significance of the Episkin model is that it could establish an alternative to animal testing for cosmetic products and ingredients and raises the possibility that such alternatives can entirely replace animal testing as the method used to verify the safety of cosmetics and cosmetic ingredients in China. However the usage and acceptance of the Episkin model is fraught with many problems.

In China cosmetics are regulated by the CFDA. The Episkin model is currently only approved by the SAICC for marketing but is not acknowledged by CFDA. Without the support of CFDA, it is not worth spending money to buy the model which has no regulatory precedent. Even if the Episkin model is accepted by CFDA, it will be a slow legislative process and extremely difficult to popularize the model. Qi Liubin, Director of Cosmetics Division for the CFDA spoke to Chemlinked stating that “in the following few years the alternatives won’t replace animal testing”. The reality is that although the Episkin model offers many technical benefits in safety substantiation for those awaiting its approval it would be a good idea not to hold their breath.