AltTox Digest
March/April 2012

China Begins the Process to Accept Non-animal Methods for Cosmetic Ingredients

On February 15^th, the China State Food and Drug Administration (sFDA) issued a draft standard of the 3T3 Phototoxicity Neutral Red Uptake (3T3PT NRU) assay for public comment. The draft, closely resembling the OECD Test Guideline (TG) 432, will be the first non-animal method to be accepted in place of the "traditional" animal method to test the safety of cosmetic ingredients. This is the first step in the sFDA's 5-year program to move cosmetic ingredient and product safety testing to more internationally acceptable methods.

Much of the basic work within China for the method was conducted by the Guangdong Province Center for Disease Control (GD CDC) which goes back several years. The GD CDC first proposed the use of the method to the Ministry of Health (MOH) based on their extensive evaluation of the method but was delayed, in part, to the transition of cosmetic regulation from the MOH to the sFDA. As recently as November of last year, the GD CDC held a meeting to establish a set protocol, training, and evaluation of the method which several Western companies and organizations were able to participate. Following work between the GD CDC and the sFDA in December, the sFDA felt the method was sufficiently developed within China to write a draft standard for public comment. The method is expected to be accepted by summer or early fall of 2012.

Information for this article has been provided by Dr. Brian Jones, Director of Education and Outreach, Institute for In Vitro Sciences.

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