This article is part of our special report An animal-free path towards EU’s sustainable chemical ambitions.
The EU is leading the way in protecting animals used for scientific purposes and transitioning to chemical safety assessment using alternative methods. But how can we remain in pole position and accelerate our move away from conventional animal tests?
Maurice Whelan is Head of the Chemical Safety and Alternative Methods Unit at the European Commission’s Joint Research Centre (JRC).
As an integral part of the JRC, the EU Reference Laboratory for alternatives to animal testing, better known as ECVAM, has been developing, validating and promoting scientific methods to replace animal tests for 30 years.
Since 1991, we’ve worked on over a hundred methods at various stages of development, validation and regulatory acceptance. The first ECVAM-validated methods were proposed as test guidelines for skin corrosion in 1998 and since then, considerable progress has been made in Europe and across the globe. As more scientifically valid alternatives become available, our laws dictate that they must be used. However we still face the challenge of how to eventually provide all the toxicological information needed to fulfil regulatory requirements using only non-animal approaches.
Meaningful collaboration drives progress
When tackling challenges, we often think first about science and technology gaps and how we might fill them. But equally important is assembling the right team that can make things happen. The European Partnership for Alternative Approaches to Animal Testing (EPAA) is unique in that it brings together the European Commission with companies working with a wide range of chemicals, including those used in the pharmaceutical, cosmetic, agrochemical, fragrance and detergent sectors.
EPAA project teams combine extensive knowledge and expertise on science, technology, regulation and policy, which ensures a holistic approach to address well-formulated objectives. This is illustrated by a new project on New Approach Methodologies (NAMs) that builds on the successful EPAA blue-sky workshop on repeated dose toxicity held in 2019. The goal is to use case studies to figure out together how to deploy NAMs in the most effective and credible way to generate the data required to inform decisions on occupational and consumer safety.
Safe and sustainable chemicals
The Chemicals Strategy for Sustainability sets out ambitious and far-reaching objectives to achieve the EU’s zero pollution ambition, a key commitment of the European Green Deal. Much of the focus is on enhancing the protection of human health and the environment through several initiatives, many of which will likely require the provision of additional toxicological data to assess more chemicals for a wider range of adverse effects. However, the strategy also outlines ways to avoid unnecessary animal testing, including assessing and regulating substances in groups, improving the sharing of information, and making better use of ‘academic’ data in safety assessments.
Moreover, the Commission is looking specifically at how proposals to extend REACH information requirements could be addressed in some way using NAMs. And for this we’ll have to look from two perspectives -at the reliability and relevance of the NAMs themselves, but also at how information requirements can be formulated to better match the type of mechanistic data that NAMs typically deliver. It is very fitting then that the theme of this year’s EPAA annual meeting (27 Oct) is “How can EPAA help the successful implementation of the EU Chemical Strategy for Sustainability”.
Investing in targeted research
The EU continues to invest in research to ensure that the right scientific knowledge and tools are available for NAM-based approaches to chemical safety assessment. The EU-ToxRisk project, funded to the tune of 30 MEuro under Horizon 2020, has just come to the end of its 5 years. It has delivered on several fronts, including showing very convincingly how NAMs can be used to support chemical grouping and read-across to avoid the generation of new animal data.
The EURION cluster of 8 individual projects received approximately 50 M Euro from H2020 and is about midway through its programme. It is focusing much of its effort on NAMs for identifying endocrine disruptors. Just recently, the ASPIS cluster commenced its broad array of research activities. It comprises the Ontox, PrecisionTox and RiskHunt3R projects and benefits from about 60 M Euro of EU funds.
Translating science into solutions
For science to have impact, research strategies need to consider the particular needs of regulation and industrial end-users. Critically too, progress depends on being able to address complex toxicological effects of most concern, such as those contributing to reproductive disorders, neurodegenerative diseases and cancer. As scientifically credible solutions emerge, the community needs to do more to ensure they are sufficiently standardised and validated to be acceptable and deployable for regulatory applications. All this is possible through cooperation, determination and a strong belief in our common goals.