First Non-Animal Test Method Accepted by China FDA

December 1, 2016

IIVS and stakeholders around the world welcomed the announcement last month by the CFDA that data from a non-animal test method can now be used to substantiate the safety of cosmetics made in China. The test, known as the In Vitro 3T3 NRU Phototoxicity Test (OECD Test Guideline 432), measures a chemical’s potential to cause harm after exposure to light.

The announcement came shortly after the 4th annual training of CFDA provincial regulators by IIVS scientists in Hangzhou, China. These annual trainings are a key component of a Memorandum of Understanding between the CFDA’s National Institute for Food and Drug Control (NIFDC) and IIVS, and are designed to assist the CFDA with the adoption and implementation of non-animal methods. To date over 400 scientists have received hands-on training in non-animal methods, including the 3T3 Phototoxicity assay. These training efforts are supported by IIVS’ Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA).

Following the announcement, the NIFDC posted the recently released IIVS-produced training video on the 3T3 NRU Phototoxicity test to its website to help facilitate implementation of the method.