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What Does China's Approval Of The First Contemporary Non-Animal Testing Method Mean For Cruelty-Free Cosmetics?

22/11/2016 11:41

Last week, the China Food and Drug Administration (CFDA) approved the first contemporary non-animal testing method that can be used for safety tests in cosmetics. This is encouraging news for consumers and animals.

The test in question is known as the 3T3 Phototoxicity assay, which measures a chemical's potential to cause harm after exposure to light.

The Institute for In Vitro Sciences (IIVS), CFDA and its subsidiary body, the 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 scientific cooperation agreement around the use of non-animal (in vitro) methods for safety assessments. Recently, IIVS has been working within China on an inter-laboratory evaluation of an in vitro test for sunlight-induced "phototoxicity"--the 3T3 Neutral Red Uptake Phototoxicity Test. The CFDA's decision to approve this method is in line with its ongoing efforts to update its cosmetics regulations to further align China's regulatory framework with those of key international trading partners.

Cruelty-Free Impact?

With an estimated 350,000 or more animals used in 2015 to meet Chinese pre-market test requirements for finished cosmetics, acceptance of these and other alternative test methods for cosmetics is a significant move forward. However, it is important for our continued progress in China that we do not overstate what the acceptance of such test methods might mean.

The acceptance of in vitro methods will not suddenly open the doors for cruelty-free brands to be sold in China or for multinationals--who already sell in China--to end their animal testing in China.

CFDA acceptance of the 3T3 NRU phototoxicity test will have little impact on animal testing for imported cosmetics, which are subject to testing for eye irritation and skin irritation-not phototoxicity. For special-use cosmetics that would otherwise be subject to animal testing for phototoxicity, there may be a small reduction in animal use; however, this is only one of a number of required tests, and until alternative methods gain acceptance in China for all relevant test areas, animal use will unfortunately continue at a high level.

Make no mistake, being able to use data from an alternative test in a Chinese safety assessment is a massive step forward; however, until China changes its rules about mandatory animal testing, the acceptance of such alternative test data will not immediately impact the ability of cruelty-free brands to sell in China. Nor will it remove the possibility of post-market animal testing by provincial FDAs, which may conduct other toxicological animal tests or may not have the capacity to use or choose not to use the alternative method.

Continued Efforts

Humane Society International has been hard at work on the ground in China to facilitate a shift in CFDA policy regarding both the acceptance of alternative tests and the removal of animal testing requirements. Since 2014 we've supported IIVS and our Chinese partners with more than $200,000 in grant funding for sponsorship of alternatives conferences and educational text books, continuing education, hands-on training, and more. HSI scientists also co-authored two chapters to the academic text Toxicity Testing Strategy in the 21st Century: Principles and Practices, the first of its kind in China.

And we're not stopping there. Earlier this year we signed a Memorandum of Understanding with Guangzhou CHN-ALT Biotech Co. Ltd. to collaborate on a wide range of exciting educational projects focused on cosmetic safety testing to promote modern, non-animal techniques in China, including expansion of China's only authorized website for alternative methods, vitrotox.com.

Our work in China is slowly coming to fruition, but we've not yet consigned cosmetics animal testing to the history books. We're working hard to continue the necessary pressure to facilitate further change and end cosmetics cruelty worldwide, once and for all. Hundreds of thousands of suffering animals depend on it.

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