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
March 28, 2019
The Illinois state Senate has passed a bill which would amend the state's Food, Drug and Cosmetics Act to include a ban on the sale or import of cosmetics that have been tested on animals. Overall, the bill is in line with the California Act which is currently the most stringent law within the U.S.
The Illinois bill is now being considered by the state's House of Representatives.
March 22, 2019
We are pleased to share that today China’s National Medical Products Association (NMPA) has approved new methods for the regulations of cosmetics. Among these are two in vitro methods: DPRA for skin sensitization and the Short Time Exposure (STE) assay for eye irritation. IIVS’ International Outreach Program introduced these methods during its training program with NMPA and we will continue to support their implementation in key laboratories.
February 21, 2019
Measures outlined in the Industrial Chemicals Bill 2017, passed by the Australian senate on 19 February, 2019, will apply to both imported and Australian produced chemicals for use as cosmetic ingredients. The commencement date is set for July 2020 although it is believed that the cosmetics industry will not need an entire year to implement changes to comply with the new law. Additionally, the bill includes funding for the development of alternative test methods.
Read the full article.
November 26, 2018
The JRC's EU Reference Laboratory for alternatives to animal testing (EURL-ECVAM), is organizing a Summer School on May 21-24, 2019 at the JRC Ispra site in Italy.
The “JRC Summer School on Non-Animal Approaches in Science: Challenges and Future Directions" intends to share knowledge and experience on the latest non-animal approaches used in research and testing including in vitro methods and computational modelling.
It is tailored for post-graduate students (PhD/Master) and young scientists, active in fields related to toxicology, biomedical research, alternative methods, exposure science, or risk assessment.
Find out more, including how to apply and a draft agenda. Applications are now open until 15 January 2019.
October 29, 2018
The tobacco industry is facing increased testing requirements for e-cigarettes and other tobacco products that entered the market after Feb. 15, 2007. Companies hope in vitro tests that use human lung cells or tissues will be sufficient to show that their new tobacco products, including e-cigarettes, significantly reduce harm and disease and benefit the population as a whole when compared with traditional cigarettes. Several of them are working with independent, third-party laboratories, including the Institute for In Vitro Sciences (IIVS), to standardize in vitro assays for respiratory toxicology so that results from one lab can be easily compared with results from another.
IIVS' Holger Behrsing discusses with C&EN.
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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October 2, 2018
Among the topics discussed at the annual Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) meeting held in early September was ways to encourage both regulators and regulated industry to use new approach methodologies (NAMs).
The meeting brought together experts from academia, industry, and animal welfare organizations and the importance of collaboration among the different groups and geographical regions was a recurring theme.
October 1, 2018
California now has the most stringent cruelty-free policies in the U.S., following Governor Jerry Brown's signing of the bill banning the sale of cosmetic products and ingredients tested on animals. The California Cruelty-Free Cosmetics Act brings California in line with the EU and other global standards but still includes some exemptions for animal tests conducted to achieve compliance with other bodies, leaving some unanswered questions.