Regulators should walk the talk on non-animal methodologies

Alternatives to animal testing are already available for companies in their decisions on the safe use of ingredients, including in silico (biological tests carried out entirely in a computer), in vitro (experiments conducted outside of a living organism) and genomics data. [SHUTTERSTOCK/STELLAE]

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

With different chemical-related proposals on the table, it is crucial to ensure that EU legislation is adapted to not include testing on animals, according to an industry expert.

“I’m not a politician, I’m a scientist, and in my work, I always look at the best science that is available to make decisions on safety,” Rob Roggeband, senior director at the multinational corporation Procter & Gamble (P&G), told EURACTIV in an interview.

Roggeband is the industry co-chair of the European Partnership for Alternative Approaches to Animal Testing (EPAA), a platform that brings together the EU executive and the private sector to promote alternative approaches to animal testing.

He said the EPAA mission is to build confidence with the regulator and accept these alternative methods.

However, the new EU’s chemical strategy could lead to more animal testing, a concern expressed by stakeholders on several occasions.

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

“I’d like to look at this [chemical strategy] as an opportunity to make progress even faster on non-animal methodologies (NAMs),” he said.

Complete animal-free science is still out of reach as there are situations where animal testing is needed, particularly in pharmaceuticals.

“There may be situations where you still need to do an animal study. But I would want that to be the exception,” he added.

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Science is faster

Since 1986, the EU has been providing specific legislation for the protection of animals used for scientific purposes, with the latest revision occurring more than a decade ago.

However, animals must be used systematically for clinical trials and testing chemicals under the existing legislative framework.

According to Commission figures, animals were used for scientific purposes 9.58 million times in 2017, mainly for research purposes (69%), regulatory use to satisfy legislative requirements, (23%) and routine production (5%).

Among the testing carried out for regulatory purposes, 61% involved medical products for humans, while 15% concerned veterinary medicinal products.

An unavoidable element in the NAMs development discourse is that science is continuously evolving while the regulatory framework can only partially capture this constant progress.

For Roggeband, regulators have been clever enough to put certain fast-changing aspects in the annexes of the legislation.

“This way, you don’t need to overhaul the entire legislation, but you can do what they call adaptations to technical progress of legislation,” he explained.

He added that making sure that the EU laws are adapted to NAMs remains crucial as some changes to regulatory texts are needed to evolve in this area.

“We need to walk together with the regulator on this, but they also need to walk the talk on NAMs,” he said.

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Lawmakers in the European Parliament have adopted a non-binding resolution asking the EU executive to come up with an action plan to phase out the use of animals for scientific experiments and tests.

Best science available

These non-animal approaches include all test methodologies which do not involve new in vivo testing.

For Roggeband, private companies are always looking at what is already available in their decisions on the safe use of ingredients, whether it is in silico (biological tests carried out entirely by computer) or in vitro (experiments conducted outside of a living organism), even considering genomics data.

“We make decisions on the safe use of ingredients for workers, consumers, and the environment, without necessarily defaulting to a tick box approach on animal studies,” he said.

An “enormous amount of knowledge” generated over the past few years on the human genome and mechanisms of action for toxicology in humankind have helped companies and researchers make decisions on safety.

“It’s not easy as you have to put all these pieces of the puzzle together to make decisions, but there are already possibilities to do that,” he said.

This also means that using the best science available does not necessarily involve resorting to animal studies.

“The wrong place to start would be to say: let’s do all this animal testing at a very high dose that does not have any relevance for human safety risk assessment,” he added.

As they become increasingly available, these new methodologies should not be confined to Europe.

“We should also apply NAMs to the other countries and outside of Europe,” Roggeband said, pointing out that third countries are also making progress in this area.

However, safety standards remain the usual red flag in applying NAMs globally. “We should never compromise on safety to consumers and workers. It is our golden standard,” he concluded.

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[Edited by Alice Taylor]

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