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

Abstract

Animal use for testing chemicals under REACH continues to increase, despite advances in non-animal safety science during the past 15 years. The application of modern science and technology, and the use of ‘next generation’ weight-of-evidence assessment approaches, are embedded in EU guidance for establishing the safety of cosmetics and foods – and of the ingredients used in these products. However, this is still not the case for the regulation of chemicals. Under the new Chemicals Strategy for Sustainability, thought leaders in human health and environmental protection are calling on the European Commission to quickly embrace the benefits of modern and innovative non-animal safety science, in place of outdated animal testing, if the EU is to be a leader in safe and sustainable innovation under the European Green Deal transformational change ambitions. The European Commission also needs 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. We are at a tipping point for closing the gap between regulatory chemicals testing and modern safety science. 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.

A framework for chemical safety assessment incorporating new approach methodologies within REACH

“…Fentem et al ( 2021 ) stated that we are at a tipping point in the development of chemical safety assessment methodology. They pointed out that Article 25 of the REACH legislation states that “testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last resort” (EC 2006 ).…”

“…This indicates that the provisions within REACH for the use of non-animal assessment methods may not yet be used to their full potential. Fentem et al ( 2021 ) called for the joining of forces across policy makers, scientists, regulators, and lawyers, to lead the paradigm shift which would truly allow animal testing to be a last resort.…”

Ready for regulatory use: NAMs and NGRA for chemical safety assurance

“…The research has perhaps become a self-sustaining entity in its own right, moving from FP6 to FP7 to SEURAT-1 to EUToxRisk 5 to RiskHunt3R 6 with no clear plan for application or acceptance in the regulatory world of the science that addresses complex systemic human health effects. This situation may only be compounded further in the future, depending on how the EU's Chemical Strategy on Sustainability (Fentem et al, 2021) chooses to embrace modern safety science.…”

The EU chemicals strategy for sustainability: an opportunity to develop new approaches for hazard and risk assessment

“…There is an increasing demand for application of NAMs, not only motivated by the intention to reduce animal testing, but also by concerns of weak predictivity of established animal test models. Moreover, there is a need to increase the capacity of chemical testing (Fentem et al 2021 ; Parish et al 2020 ) to keep up with chemical innovation. It has been argued that the increasing rate and diversity of production of chemicals exceed societies’ ability to efficiently conduct safety-related assessments and monitoring and thus transgress the safe operating space of the planetary boundaries for novel entities (Persson et al 2022 ).…”