Unilever: EU needs ‘paradigm shift’ in chemical safety assessment methods

Writing in Alternatives to Laboratory Animals​, ​researchers from Unilever’s Safety & Environmental Assurance Centre in the UK, led by Julia Fentem, said the EU was at a “tipping point”​ for closing the gap between regulatory chemicals testing and modern safety science and far-reaching collaboration was now necessary to stimulate change.

“It is time to join forces, across policy makers, scientists, regulators and lawyers, to lead the paradigm shift needed to deliver what EU citizens want – namely, chemicals and products that are safe and sustainable without resorting to animal testing,”​ they wrote.

Next-generation approaches must be applied to chemicals​

In 2013, animal testing on cosmetic products and cosmetic ingredients was banned under the EU Cosmetics Regulation 1223/2009​​ following initial bans on testing for finished products in 2004 and ingredients in 2009. Since this EU ban, non-animal methods (NAMs) had fast advanced in the field of cosmetics safety assessment.

However, whilst use of these “next-generation”​ methods, including weight-of-evidence approaches, were embedded into EU guidance for establishing the safety of cosmetics, food and ingredients within these products, the Unilever researchers said, this was “still not the case for the regulation of chemicals”.​

Under the European Chemicals Agency’s (ECHA) REACH Regulation 1907/2006​​, animal tests were still enabled or required for some chemicals, notably when testing for environmental endpoints like aquatic toxicity, long-term worker safety or the pre-registration of some new chemical substances. And this, they said, was despite a raft of NAMs being appropriate to fulfil these data needs.

The Unilever researchers said there was clearly a “regulatory testing-modern safety science gap for chemicals safety assessment”​ in the EU – a gap that needed to be closed.

Animal testing ‘as a last resort’ must be enabled by the EC​

It was time now for the EU to “pause and think more critically”​ about the ongoing issues around chemical testing, they said, and plenty could be learned from the “ambitions and strategic leadership”​ shown by the US Environmental Protection Agency (EPA) and its former administrator Andrew Wheeler. In 2019, Wheeler signed a directive to prioritise efforts to reduce animal testing, announcing €3.61m ($4.25m) in funding for five universities to research the development and use of alternative test methods and strategies to advance its goal of completely eliminating animal testing by 2035.

The European Commission (EC) had to enable companies to meet their legal obligation to only conduct animal testing as a last resort by “providing a more flexible, science-based and consistent regulatory framework for assuring chemical safety, which supports the integration of data from different sources”, ​the Unilever team wrote.​

Action had to now be solely orientated towards non-animal methods (NAMs) as the default approach for assessing chemical safety, they said, which would also enable higher throughput, faster decision-making, and scientifically sound data generation for the assessment of chemical mixtures.

“We are at a tipping point – a paradigm shift in how we assess chemical safety in the EU is essential, and the European Commission must quickly embrace the benefits of modern and innovative safety science in place of outdated animal tests if it wants the EU to be a leader in safe and sustainable innovation under the European Green Deal,”​ the Unilever executives said.

Cruelty-free cosmetics European Citizens’ Initiative​

For the last year or so, the beauty and personal care industry had collectively joined forces with ingredient suppliers, NGOs and trade associations on these issues around animal testing requirements for chemicals under REACH, to protect the existing EU animal testing ban for cosmetics. Open letters to EU agencies​, joint public statements​ and campaigns​ were just some of the actions that had been taken by these collectives thus far.

And, most recently, Unilever’s Dove brand and Natura &Co’s brand The Body Shop spearheaded a European Citizens’ Initiative​ calling on the transformation of the EU chemicals regulation, among other things, to protect cruelty-free cosmetics. Action on the ground was also being taken by trade associations and industry via the launch of a New Science Programme next year​ to drive and shape future worldwide uptake and regulatory acceptance of non-animal testing alternatives in cosmetics.

Members of the European Parliament (MEPs) had since adopted a historic resolution vote​ calling on the European Commission to establish an EU-wide action plan to actively phase out animal experiments – a move that added weight to the cosmetic industry’s fight to protect its sector-specific ban. The EC would be expected to respond to this vote within the next three months.

The Unilever team said a commitment by the Commission to “follow the lead from the US authorities” ​to invest in effective knowledge transfer between the safety science and regulatory communities was one strong way forward to building out and mainstreaming next-generation non-animal safety science capacity in the EU for chemicals.

Source: Alternatives to Laboratory Animals​
Published online ahead of print, doi: 10.1177/02611929211040824​​
Title: “Upholding the EU’s commitment to ‘animal testing as a last resort’ under REACH requires a paradigm shift in how we assess chemical safety to close the gap between regulatory testing and modern safety science”​
Authors: J. Fentem, I. Malcomber, G. Maxwell and C. Westermoreland