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Breaking News: An In Vitro Testing Method for Phototoxicity of Chemical Raw Materials Used in Cosmetics Accepted by CFDA

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On 11th Nov. 2016, CFDA released a notice to adopt In Vitro 3T3 Neutral Red Uptake Phototoxicity Assay (In Vitro 3T3 NRU PT) on cosmetic ingredients. This method is added to the Chapter VI of Technical Safety Standard of Cosmetics 2015. As we know, In Vitro 3T3 NRU PT has been consulted in public since 2012 and final accepted after 4 years. Definitely, it represents a step forward toward alternative methods in cosmetics in China.

In Vitro 3T3 NRU PT was developed and validated in a joint EU/COLIPA project from 1992-1997. In April 2004, In Vitro 3T3 NRU PT was finalized and adopted as OECD No. 432 for the assessment of chemical substances by in vitro approach. Chinese version of 3T3 NRU PT is compiled based on OECD No. 432. 2004 and Annex VI to Consolidated Version of Directive 67/548/EEC. This method is recommended to be used in the evaluation of potential phototoxicity of cosmetic ingredients.

CIRS Comments:

  • Alternative methods can be used for the application of new cosmetic ingredients having UV absorption.
  • Given this method is added to the Chapter VI of Technical Safety Standard for Cosmetics 2015, so it will be available for the evaluation of both cosmetic ingredient and finished products. Phototoxicity test is required for hair growth, anti-freckle and sunblock in China.
  • Animal testing methods of phototoxicity can be used as well in China. Perhaps, animal testing ban will not be applicable in China as EU. It will be optional for enterprises to choose the methods in terms of demands and property of products.

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