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Acceptance of First Non-Animal Method by China FDA Anticipated

November 2, 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

Technical Training in Non-Animal Safety Methods Held in China

December 19, 2013

GAITHERSBURG, MD, December 16, The Institute for In Vitro Sciences (IIVS), with support from its Industry Council for the Advancement of Regulatory Acceptance of Alternatives (ICARAA), conducted a training course on September 23-27 for in vitro safety testing methods for scientists from China’s NIFDC (National Institutes for Food and Drug Control), a division of the China Food and Drug ...

China | Education & Outreach

IIVS Announces the Opening of a Non-animal Testing Laboratory in China

November 14, 2017

GAITHERSBURG, MD – Nov. 14, 2017 – The Zhejiang Institute for Food and Drug Control (ZJIFDC), responsible for  regulatory review of food, drugs, and cosmetics produced in Zhejiang province, has opened a non-animal testing laboratory after successful scientific collaboration with IIVS.  Based near Shanghai, the ZJIFDC made the decision to open the new lab back in 2013 to keep...

China

European Partnership Supports IIVS Training of Chinese Scientists in Non-animal Tests

May 9, 2019

Gaithersburg, MD – May 8, 2019 – The Institute for In Vitro Sciences, Inc. (IIVS) has received a grant from the European Partnership for Alternative Approaches to Animal Testing (EPAA) to support its annual training of Chinese scientists in non-animal testing methods. As part of the agreement, two scientists from BASF SE, a member of EPAA, will join IIVS to provide hands-on training in China for four non-animal approaches for skin sensitization. This training follows the recent announcement by China’s National Medical Products Association (NMPA) of acceptance of one non-animal method for skin sensitization, DPRA, which will be included in the training. “We are proud to have the support of EPAA for our training program(s) which are designed to build proficiency and capacity in non-animal test methods in China,” states Erin Hill, President of IIVS. “We approached BASF scientists to assist us, given their technical proficiency in the tests and experience in providing training. Their inclusion allows us to provide a comprehensive training of internationally validated test methods, as well as introducing a newly developed method, the Kinetic DPRA.” IIVS’ annual training is part of a Memorandum of Understanding between IIVS and China’s National Institute for Food and Drug Control (NIFDC), a technical subordinate agency of the NMPA. IIVS and the NIFDC work together to assist Chinese scientists in becoming proficient in non-animal test methods to support China’s movement toward accepting alternative tests for the regulation of cosmetics. Recently IIVS was appointed to the NIFDC’s Alternatives Working Group. IIVS and EPAA have collaborated previously to produce full length training videos for non-animal test methods which have been translated into Chinese, Portuguese and Spanish. These videos are available free of charge at the EPAA website, YouTube, and also distributed at IIVS trainings. Similarly, BASF and IIVS have collaborated over the years to promote the development and standardization of in vitro test methods. Most recently the two organizations worked to officially import the LuSens cells into China where they will be maintained at the NIFDC and distributed to appropriate laboratories. The LuSens assay for skin sensitization will also be taught in the 2019 training course. 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 www.iivs.org. Media Contact: Erin Hill President Phone: 301-947-1281 Ehill@iivs.org    

DPRA | Short Time Exposure | Cosmetic & Personal Care | Alternative testing in China | Alternative Testing Methods | BASF SE | China | DPRA | EPAA | Erin Hill

China’s Compulsory Animal Testing for Cosmetics May Take More Than Five Years to Stop

October 17, 2018

By Amanda Lim, Editor (Singapore) CosmeticsDesign-Asia.com

  Although China has made significant strides in moving away from animal testing, its challenges suggest it may take more than five years for the country to completely stop compulsory animal-testing for cosmetics, says Hedy He, regulatory analyst and editor of ChemLinked: "In the short term a total ban on animal testing is unlikely given the lack of testing infrastructure and technical capacity shortcomings of the industry."

The Overarching Issue

Among the many obstacles, the overarching one is the insufficient technical capacity China faces when it comes to cosmetic safety assessment. He describes the country's cosmetic industry as fragmented with a market share divided among small and medium enterprises with relatively weak technical capacity. "China's government must take a major role in assuring product quality and safety assurance." He said.

The Botanic Factor

According to He, one of the biggest problems is that China's alternative methods are not developed enough: "The premise of stopping animal testing is the maturity of alternative methods.  At present, China still faces many challenges in the research and application of alternative methods." Currently, China is still unsure on whether botanical substances can be tested by alternative methods. Of the 8783 kinds of cosmetic ingredients in the inventory of Existing Cosmetic Ingredients in China (IECIC), 30% of them are animal and plant extractions. As demand for botanical ingredients continue to grow in the market, so does the challenge to find alternative methods to safely test them, said He. He explained that botanicals present obstacles as they are complex and derived from a large and varied class of materials that includes extracts, hydrolysates, juices and powders.  Additionally, He said colored substances can impede testing. These challenges are further complicated as the Organization for Economic Cooperation and Development's (OECD) testing guidelines do not align with China's own definition of cosmetics.  This makes botanical ingredients, and many cosmetic products as well, unsuitable for in vitro assessment, explained He.

Further Complications

Among the alternative methods in OECD guidelines are four approved skin models and two approved corneal models.  However, the intellectual property rights for these are owned by overseas enterprises and only one type can be produced and purchased in China. To conduct these tests overseas would also not be viable as the biologically active in vitro reconstructed human models would be greatly affected by transportation. As for domestic models, according to He, they are hardly validated and accepted worldwide. The cherry on top of the already complicated situation is money, said He.  "The strong method patent protection and special testing facilities will both increase the cost of testing and affect the promotion of alternative methods in China."

Right Foot Forward

The good news is that China has been taking measures that suggest they are keen on stopping compulsory animal testing.  To its credit, China has been investing heavily in new laboratories as well as training in non-animal testing. In collaboration with the Institute for In Vitro Sciences, a U.S. non-profit research and testing laboratory, Zhejiang FDA opened a non-animal testing laboratory in 2017.  There, they have been training Chinese scientists annually in tests using reconstructed skin cells for testing. Recently, the China Working Group for the Validation of Alternative Methods was established to improve the validation and utilization of alternative testing methods. This year, four alternatives to animal testing were opened for public consultation and are currently considered draft proposals.  Currently only two methods have been approved. The first was an alternative method for phototoxicity, which was approved two years after China waived animal testing on domestic non-special use cosmetics, such as nail polish.  The second was a test for skin corrosion, which was approved just last year.  

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3T3 Neutral Red Uptake | BCOP | Phototoxicity | Sensitization | Cosmetic & Personal Care | alternatives to animal testing | China | Education & Outreach | skin sensitization

IIVS Appointed to China’s Alternatives Working Group for Cosmetics

October 9, 2018

Gaithersburg, MD – October 9, 2018 – U.S. based Institute for In Vitro Sciences (IIVS) has been invited by China’s National Institute for Food and Drug Control (NIFDC) to join their working group on alternatives for cosmetics.  The newly established group was announced by the NIFDC during their 2^nd International ...

Cosmetic & Personal Care | alternative methods | Alternative Testing Methods | alternatives to animal testing | Erin Hill | NIFDC | non-animal testing

International Outreach Program

March 21, 2017

IIVS has worked collaboratively with international governments to help them implement non-animal test methods for the regulation of products and ingredients. Since 2010 a major area of focus has been working with the Chinese government to replace animal testing for the registration of cosmetics. This work is done under a Memorandum of Understanding with China’s Institute for Food...