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Acceptance of first non-animal method by China FDA anticipated

November 02, 2016

GAITHERSBURG, MD - November 2, 2016 - The Institute for In Vitro Sciences (IIVS) welcomes the news from China Food and Drug Administration (CFDA) officials that - for the first time in China - data from a non-animal test method will soon be recognized for safety evaluations of cosmetics.

The method, known as the 3T3 Phototoxicity assay, measures a chemical's potential to cause harm after exposure to light. The test has undergone formal validation internationally and has been incorporated into the OECD Test Guideline program (OECD TG #432). A subsequent inter-laboratory evaluation of the test was conducted in China with input from IIVS. Once the method is officially published by CFDA, it can be used to substantiate the safety of cosmetics, personal care products, and their ingredients.

"The anticipated publication by CFDA is an extremely important step for China" says Erin Hill, Co-Founder and President of IIVS. "It clearly demonstrates China's commitment to modernize their testing requirements and reduce their reliance on animal models".

IIVS and CFDA/National Institute for Food and Drug Control (NIFDC), which has regulatory authority over cosmetics in China, have been working together for several years under a Memorandum of Understanding (MOU) for scientific exchange around the use of non-animal (in vitro) methods for safety assessments. A key component of the MOU is an annual hands-on training provided by IIVS to national and provincial Institute for Food and Drug Control scientists. Over the past four years, approximately 400 regulatory scientists have been trained in methods such as phototoxicity, skin and eye irritation and skin sensitization. IIVS, together with NIFDC, is currently holding its 4th annual training at the laboratory facility of the Zhejiang Institute for Food and Drug control in Hangzhou, China.

IIVS Educational and Outreach programs are made possible by funding provided by its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA), other individual companies and animal protection organizations such as PETA.

About IIVS IIVS is a non-profit organization wholly dedicated to the promotion of rapid and innovative non-animal test methods Founded in 1997, IIVS is recognized as a leading provider of in vitro testing in support of toxicological safety evaluations. Rigorous scientific programs coupled with educational and outreach initiatives have established IIVS as a global leader in the advancement of alternatives to animal testing. For more information, visit http://www.iivs.org.
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Institute for In Vitro Sciences

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