The JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) has just published its Status Report 2019 on the development, validation and regulatory acceptance of alternative methods used for scientific purposes.
The report provides an extensive overview of activities undertaken by EURL ECVAM and its collaborators covering major research projects, test method validation studies and peer reviews, regulatory acceptance and adoption of alternative methods at an international level, initiatives to boost knowledge sharing across sectors and communities, and activities to bring the Three Rs into the classroom.
According to JRC scientist Adelaide Dura, production-editor of the status report, “We’ve included a whole host of bite-sized topics in an easy-to-navigate layout and so we hope our readers will be able to readily access the content they’re most interested in”.
Publication of the status report is particularly timely considering the release on 6 February 2020 of the European Commission’s report on the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes in EU Member States. The related statistics on the use of animals for procedures conducted in the EU during the period 2015 to 2017 show two main use-areas: basic and applied research (68%), and testing of drugs and other chemicals to meet regulatory requirements (23%).
Where is progress being made?
Mechanistically driven toxicology continues to emerge as an optimal way to inform chemical hazard assessment using data from alternative methods, with focus in recent times on repeated-dose, developmental and reproductive toxicity. Valérie Zuang, JRC scientist and content-editor of the status report notes, “We’ve seen significant advances in read-across approaches that combine features of chemical structure with in vitro bioactivity data to identify similar chemicals to fill data gaps and avoid unnecessary animal testing. This is particularly applicable to satisfy information requirements under REACH, for example”.
EU-funded projects are also delivering standardised, scientifically valid non-animal methods available for the safety and potency testing of vaccines for human and veterinary use.
With a view to encouraging the uptake of alternatives in basic and applied research, EURL ECVAM is undertaking major reviews in seven important disease areas. Results on the use of non-animal models and methods for investigating respiratory tract diseases and neurodegenerative disorders will be published in the coming months. Laura Gribaldo, the JRC scientist overseeing the reviews observes, “It’s been a pleasant surprise how much activity is actually going on regarding the development and use of non-animal models and methods in biomedical research, for example to understand disease etiology and to discover new therapies”. Preliminary results show an increasing preference of scientists for sophisticated bioengineered technologies including 3D human tissue cultures and microfluidic ’organ-on-chip’ devices.
With support from the European Parliament, EURL ECVAM has been expanding its activities in education and training to facilitate, for one, incorporation of the Three Rs (Replacement, Reduction and Refinement of animal use for scientific purposes) into high school and university curricula. In addition to producing guidance for decision-makers in educational organisations, significant effort is also being invested to develop a variety of learning scenarios and associated teaching resources. According to the JRC’s Marcelle Holloway, “Thanks to our very fruitful collaboration with European Schoolnet, a massive open online course on the Three Rs – a MOOC - was run in January for school teachers and some lesson plans are free to download and use, whilst the guidance and other resources will be available later this year”.
For nearly 30 years, the JRC’s EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) has been supporting the Three Rs. Its mandate is described in Directive 2010/63/EU on the protection of animals used for scientific purposes and includes a number of duties including supporting research and development activities, coordinating and taking part in validation studies, sharing information on alternative methods and promoting the uptake and use of alternative methods in an international context.
As put by JRC scientist Maurice Whelan, head of EURL ECVAM, “The Three Rs are very much embedded in EU policy. However the ultimate aim of the Directive, and thus our aim too, is to eventually achieve full replacement once it’s scientifically possible to do so”.
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