China's acceptance of certain non-animal testing methods for the regulation of cosmetics
Gaithersburg, MD – April 3, 2019 – The Institute for In Vitro Sciences (IIVS) applauds China’s National Medical Products Administration (NMPA) for their acceptance of certain non-animal (alternative) test methods for the regulation of cosmetics.
In a notice issued on March 22, the NMPA drafted acceptance of nine test methods including:
- Direct Peptide Reaction Assay (DPRA) for Skin Sensitization (OECD TG 442C)
- Short Time Exposure Assay (STE) for eye irritation (OECD TG 491)
These new regulations will go into effect January 1, 2020 and will be the preferred toxicological tests for the registration and pre-market approval of cosmetic ingredients.
In an effort to modernize their regulatory oversight of cosmetics, the NMPA and its scientific subordinate body, the National Institutes for Food and Drug Control (NIFDC), have been working to gain experience and build confidence in non-animal testing approaches. Specifically the agencies are requiring in-country technical infrastructure (i.e. testing capacity) before test methods are submitted to the Experts Committee of Cosmetics Standards by the NIFDC.
Working under a Memorandum of Understanding (MOU), IIVS and the NIFDC have collaborated on projects designed to bring alternative test methods to China. A key component in this partnership is an annual hands-on training in alternatives held for provincial MPA/IFDC scientists. To date the program has trained more than a hundred scientists in numerous test methods including the first officially approved non-animal test method, the NRU 3T3 Phototoxicity assay, and the recently approved test methods, DPRA and STE.
“We have seen first-hand how the partnership with NIFDC and our training program have built capacity and proficiency in alternatives,” said Erin Hill, President of IIVS. “The opening of the alternatives laboratory at the Zhejiang Institute for Food and Drug Control (ZJIFDC) is a wonderful example of how laboratories can expand to offer training and testing services in alternative test methods.”
Recently, IIVS was appointed to the NIFDC’s newly established Alternatives Working Group. In addition to its work with the NIFDC, IIVS collaborates with other influential groups in China, such as the Expert Committee of Cosmetics Standards and Cosmetic Review Committees, to advocate for the use and acceptance of alternative test methods.
About the Institute for In Vitro Sciences (IIVS)IIVS is a non-profit organization wholly dedicated to the promotion of 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 us at http://www.
Media Contact: Erin Hill