We discussed recent achievements and future plans with its lead author, Valérie Zuang, and with Maurice Whelan, head of the JRC's European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM).

Q: Valérie, the new status report of the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM) describes recent progress in the development of non-animal methods to test chemicals for adverse effects on human health and the environment. What would you say to someone who is not familiar with this topic, where are we exactly with finding alternatives that could replace animal testing?

Valérie: I would say that we have made a lot of progress in reducing the reliance on animal testing for safety assessment. The EU is the world leader in protecting animals used for scientific purposes. We have fully revised comprehensive legislation (adopted in 2010) protecting laboratory animals but also aiming for better science. We also have specific regulatory actions such as the 2013 EU marketing ban of cosmetics tested on animals. Both measures have given a strong impetus to the shift to alternative methods.

A lot has been done recently to show how in vitro and computational methods can be used to predict the toxicological properties of a chemical by 'reading across' the data from a similar chemical that has already been tested. Read-across is extensively used for example by companies registering their chemicals under the REACH Regulation since they can often satisfy information requirements without having to conduct animal testing.

Alternative methods are also being increasingly applied for the identification of endocrine disruptors and the assessment of chemical mixtures. In the case of endocrine disruptors, the type of mechanistic information that you can get from alternative methods is very valuable in determining if a chemical is in fact interfering with the endocrine system and thereby causing an adverse health effect.

Q: A lot of people are convinced that all animal tests should be phased out now. In 2015, we had the European Citizens Initiative (ECI) 'Stop Vivisection' which called on the EU to completely ban animal tests immediately. To put it bluntly, what's holding us back?

Maurice: Actually as explained in the Commission's response to the initiative, EU policy is indeed to strive for that ultimate goal. However, transitioning away from animal testing in fields such as safety assessment and biomedical research has to be done progressively and responsibly to balance ethical concerns with societal needs. The fact is we still lack convincing non-animal approaches that can address the more difficult scientific and regulatory questions.

One challenge we are facing for example is how alternative methods alone can be used to fully understand if a chemical might contribute to a complex systemic health effect such as cancer or heart disease. We are working with the Horizon 2020 flagship project EU-ToxRisk, the OECD, and regulatory agencies across the world to tackle this and to explore how the latest advances in non-animal approaches to safety assessment could be best used to support regulatory decision-making.

Ultimately it's all about going for the win-win-win: protecting human health and the environment, replacing animal testing, and supporting innovation and competitiveness of EU industry.

Q: The JRC has been studying a lot of innovative methods, from stem cells to various computational methods. Are there any new methods or breakthroughs in the horizon?

Valérie: Absolutely, new technologies are emerging at an ever increasing rate. 'Organ-on-chip' devices for example have huge potential. They are basically multi-channel 3-D microfluidic chips for culturing cells and engineered tissues that recreate aspects of the physiology and function of organs such as the heart, lung and liver.

Late last year we conducted an international survey of developers and potential end-users of organ-on-chip devices to understand the level of activity and to what extent this technology could be validated with a view to building confidence and promoting uptake. We found that there has been a very rapid growth in organ-on-chip related research both in academia and industry, with a number of commercial start-ups beginning to appear. And actually the new European Organ-on-Chip Society (EUROoCS) was officially launched just last November.

Q: So what will you be working on next? What plans do you have for next year?

Maurice: We have just launched a major study to review the use of alternative methods and models for understanding biology and disease and for developing novel approaches to diagnosis and therapy.

This is really exciting since we know that there are many inspiring examples out there of how new technologies such as induced pluripotent stem cells and engineered tissue models can really capture human specific traits which animal models often fail at.

The EURL ECVAM Scientific Advisory Committee (ESAC) has been reviewing the scientific validity of antibodies and non-antibody affinity reagents generated using animal-free technologies, for use in research and diagnostics. We expect to publish their opinion in the coming months which I'm sure will receive a lot of attention.

And of course we are very much looking forward to our next JRC Summer School on "Non-Animal Approaches in Science: Challenges and Future Directions", which we will host at the JRC site in Ispra from the 21 to 24 May 2019. We are thrilled that over 120 young scientists from all over the world have signed up to attend!

Background

The European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) is an integral part of the European Commission's Joint Research Centre (JRC).

The annual EURL ECVAM status report provides updates on the progress being made in the development, validation and regulatory acceptance of alternative-to-animal methods and approaches and their dissemination.

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