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European Parliament to vote on animal-free research, testing and education

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Anyone who is familiar with Ralph, a test rabbit mascot that is subject to Draize eye irritancy test in cosmetics labs and suffers from blindness, will wonder how such cruelty is still acceptable in an age of advanced science and technology. The Save Ralph video went viral all over the world and became most probably the reason why Mexico recently joined the ranks of states, which banned animal testing for cosmetics. So did the EU back in 2013. The EU plans to go even further by adopting a resolution on “a co-ordinated Union-level action to facilitate the transition to innovation without the use of animals in research, testing and education” this week (15 September), writes Eli Hadzhieva.

Although the EU encourages the use of non-animal methods, such as the new organ-on-chip technology, computer simulations and 3-D cultures of human cells, research shows that archaic methods, such as “50 percent lethal dose” killing half of the millions of test animals, are still widely in use. Moreover, evidence growingly shows that some animals, such as rabbits and rodents, are completely different species from humans to be seen as reliable proxies for the protection of human health from chemical risks. For example, drugs, such as thalidomide, TGN1412 or fialuridine, aimed at treating morning sickness, leukaemia and Hepatitis B respectively, proved totally safe for animals but could not be tolerated by humans.

According to the European Commission, the European chemicals strategy for sustainability increased support for use of Non-Animal Methodologies (NAMs) in Chemicals Risk Assessment, especially with several Horizon 2020 projects (ASPIS Cluster comprising RISK-HUNT3R, ONTOX and PrecisionTOX projects), the upcoming REACH and Cosmetics Regulation revisions, the new project of the European Partnership for Alternative Approaches on NAMs use in risk assessment, PARC with the objective of transitioning to next generation risk assessment and a Strategic Research and Innovation Agenda. The global acceptance of non-animal and innovative approaches to chemical safety is also high on the OECD agenda.

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A webinar organised on 9 September by EU-ToxRisk and PATROLS, two multi-stakeholder projects funded by the EU’s H2020 Program, illustrated the limitations of the existing in vitro (test-tube experiments) and in silico (computer-simulated experiments) hazard detection systems while showcasing a new toolbox to conduct animal-free assessments for chemicals and nanomaterials. EU-ToxRisk project coordinator Bob van der Water from Leiden University highlighted his vision “to drive a paradigm shift in toxicology towards an animal-free, mechanism-based integrated approach to chemical safety assessment” through an established NAM toolbox based on in vitro and in silico tools and novel next generation NAM toolbox components. He emphasised advanced novel test systems, such as CRISPR-based fluorescent reporters in stem cells, stem-cell derived multi-liver-cell model, diseased liver micro-tissues and four-organ-chip while highlighting that NAMs should rapidly be integrated into regulatory testing frameworks.

Shareen Doak, the Coordinator of PATROLS from Swansea University highlighted the knowledge gaps regarding long term effects of realistic engineered nanomaterial (ENM) exposures for human and health environment while demonstrating innovative methods, such as extrinsic ENM properties, advanced ecotoxicity tests, heterotypic in vitro models of the lung, GIT and liver etc. “These methods are tailored to better understand human and environmental hazards and should be implemented as part of the EU’s safe and sustainable-by-design strategy to minimise the need for animal testing”, she said.

“The biggest challenge is the acceptance and the implementation of NAMs. Standard validation requirements are too long and the applicability domain of NAMs needs to be established considering new emerging technologies”, she added.

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In an earlier statement, the ASPIS Cluster expressed support for the motion for resolution of the European Parliament describing it as “timely to accelerate an animal-free transition and meet EU ambition to lead on the next generation for risk assessment in Europe and worldwide” all by welcoming EU efforts “which will translate into regulatory and industrial practices that will better protect human health and the ecosystems, by enabling us to identify, classify and ultimately remove hazardous substances from the environment”.

The moderator of the webinar MEP Tilly Metz (Greens, Luxembourg), also shadowing the European Parliament’s resolution, said that she hopes that the final resolution will contain the following elements: “Concrete steps to phase out animal testing, precise roadmaps and studies, a coordinated approach by EU agencies, such as the European Food Safety Authority and the European Chemicals Agency and fast implementation of new advanced methods”.

This gives a lot of food for thought for policymakers in a make-or-break moment for Ralph and his animal and human friends. It’s time that words translate into action and the regulatory environment evolves in line with new realities on the ground while giving a breathing space to these promising and safe animal-free technologies by adopting a dynamic approach to accept and use them. This will not only allow us to live up to the zero-pollution ambition in the Green Deal but will also deliver “a toxic-free environment” both for animals and humans.

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