March 21, 2017
China’s required animal testing for the registration of cosmetics poses difficulties for industry and consumers alike. Since 2010, IIVS has been working at the national and provincial levels with the China Food and Drug Administration and the import/export authorities (AQSIQ) to help them realize their goal of adopting internationally recognized non-animal test methods for the safety ...
June 17, 2014
GAITHERSBURG, MARYLAND – The Institute for In Vitro Sciences (IIVS) last week signed a Memorandum of Understanding with the National Institute for Food and Drug Control (NIFDC), a subordinate agency of the China Food and Drug Administration (CFDA). The two organizations will work collaboratively on a number of projects focused on cosmetic safety testing designed to promote in vitro (non...
October 17, 2018
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.
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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November 21, 2016
What is the Institute for In Vitro Sciences (IIVS)?
IIVS is a non-profit laboratory dedicated to promoting the use and acceptance of in vitro
(non-animal) methods for product safety testing. In Vitro
is Latin and means “in glass” as opposed to in vivo
, which means “in the living.” The two terms are used to describe the effects of cells in culture versus...
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
April 3, 2019
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:
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 www.iivs.org
January 9, 2018
GAITHERSBURG, MD – January 9, 2018 – The Institute for In Vitro Sciences, Inc. (IIVS) today announced a collaboration with BASF to import a non-animal, cell based, safety test into China. The LuSens test, developed by BASF, is an in vitro...
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...
October 17, 2018
Currently China is striving to adopt and implement non-animal, including in vitro, testing approaches for the safety assessment of cosmetics and ingredients. Collaborative efforts between industry and the Institute for In Vitro Sciences (IIVS, Gaithersburg, USA) have focused on the transfer of several OECD Test Guideline methods to government laboratories in China and have supported the creation of an in vitro toxicology testing laboratory within the Zhejiang Institute for Food and Drug Control (Hangzhou, China). Recently BASF SE (Ludwigshafen, Germany) and IIVS have partnered to introduce a cell based in vitro skin sensitization test, LuSens, into China using the principles of GIVIMP as a standard. This case study exemplifies the practical way in which the GIVIMP guidance can assist interested parties in the development, transfer and establishment of in vitro approaches.
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 ...