Two million animals stand in firing line of EU’s new sustainable chemical ambitions

As such, panelists stressed that now is the time to revisit testing strategies, highlighting the potential that non-animal methodologies (NAMs) hold given that these can, in some cases, actually produce more accurate data. [SHUTTERSTOCK]

This article is part of our special report An animal-free path towards EU’s sustainable chemical ambitions.

Requirements in the EU’s chemical strategy for sustainability would see an additional two million animals used for testing unless a concerted effort is made to invest in alternatives to animal testing, stakeholders have warned.

Presented in October 2020, the chemicals strategy is intended as a first step towards a zero pollution ambition for a toxic-free environment as a key part of the European Green Deal.

While its unveiling was widely welcomed as a step forward for human and environmental health, its presentation sparked concerns at the time from stakeholders, who warned that this would result in an increase in animals used for testing to fulfil its aims.

And, with more details emerging about the strategy’s ambitions, it seems these concerns are well-founded, according to stakeholders from the chemical industry.

EU's chemicals strategy to face animal-testing test

The unveiling of the EU’s chemicals strategy has sparked mixed reactions on whether it could act as a catalyst for phasing out animal tests or instead increase reliance on them.

Speaking at the annual conference of the European Partnership for Alternative Approaches to Animal Testing (EPAA), Dorothee Funk-Weyer, vice president of chemicals company BASF,  pointed out that the dossier as it currently stands is already causing additional testing.

This means that, as the strategy’s ambitions kick into gear to address the polymers of concern and place a stronger focus on neurotoxicity, immunotoxicity and endocrine disruption, the expected associated developments of regulatory data requirements will further fuel this.

“All of [this] will lead to more testing,” Funk-Weyer warned, estimating that more than two million additional animals would be required for this additional testing.

One substance, one assessment

Green MEP Tilly Metz positioned herself as a staunch proponent of the chemicals strategy but warned that the number of animals used in testing will increase if it is not “implemented in the right way”.

“Let us be clear, no one, or very few of us present today want less testing, but we want different testing without the use of animals,” she stressed.

Specifically, stakeholders raised concerns over the proposed changes to the registration, evaluation, authorisation and restriction of chemicals (REACH) regulation, which Emily McIvor, member of the EPAA’s mirror group, pointed out have been proposed without any impact assessment, “let alone one intended to estimate animal numbers”.

Highlighting concerns over the “one substance, one assessment” approach, which aims to streamline chemical assessments, McIvor said that animal protection organisations and the regulatory scientists working within the mirror group both fear this could result in the loss of expertise in using non-animal approaches developed over the years.

Panellists stressed that now is the time to revisit testing strategies, highlighting the potential of non-animal methodologies (NAMs), given that these can in some cases actually produce more accurate data.

For example, BASF’s Funk-Weyer pointed out that while they have their limitations for some more complex toxicology and whole organism tests, in many cases NAMs can also produce “more robust and less variable data”.

This is because they do not have to comply with animal welfare regulations, she said, meaning that testers can conduct ‘ring trials’, or repeated tests from multiple laboratories,  to corroborate data.

In comparison, in some cases just one positive reaction from one animal, which may have a particular sensitivity, may be sufficient for in vivo trials, she pointed out.

Furthermore, the test system can include human material, meaning there is no interspecies extrapolation needed, as is the case with animal studies, and, thanks to the fact that NAMs require less substance, they are often “cheaper and faster”.

“Therefore it is necessary to prioritise the research, but also the funding for this research, to close this gap to prevent animal testing from being needed,” Funk-Weyer said.

Green MEP calls for EU action plan on alternatives to animal testing

All initiatives to promote alternatives to animal testing are welcome, but lawmakers should be bolder and impose some mandatory measures as well, Luxembourgish MEP Tilly Metz has said.

Refinement: minimising animal harm, maximising scientific validity

In cases where techniques cannot be replaced or reduced, panellists stressed the need to refine them to minimise the stress of an animal used during animal testing.

“In other words, refinement aims to minimise animal harm while maximising scientific validity,” Inês Mendes Preguiça from the Faculty of Medicine of the University of Coimbra, Portugal, explained.

Mendes Preguiça nabbed the topped spot in this year’s 3Rs Science Prize, awarded by the EPAA to researchers and students who develop alternatives to animal testing, for her work developing a non-invasive and stress-free method (HaPILLness) of oral drug dosing for rodents during tests.

This is normally a “stressful and invasive” procedure via a cannula inserted directly into the rodent’s stomach, the researcher explained. Not only is this traumatising for the animal, but it can actually sway research outcomes given that the animal’s response to stress can create physiological changes, she pointed out.

Mendes Preguiça hopes her technique, currently undergoing the evaluation process for European patent protection, will help minimise the suffering of the millions of rodents used for animal testing each year while also optimising research outcomes.

Animal testing inefficiency is a fact and must be asserted, says MEP

Policymakers have the responsibility to shift the debate about alternatives to animal testing from the current contraposition between safety risks for humans and animal ethics, an MEP told EURACTIV.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

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