It is time to think differently on animal alternative approaches

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

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Rob Roggeband. [EPAA]

This article is part of our special report Alternatives to animal testing.

The European Partnership for Alternative Approaches to Animal Testing (EPAA) is a unique partnership between industry and European Commission in the EU with an overall goal to increase confidence in the use of the so-called 3Rs – Replacement, Reduction, Refinement of animal testing – a concept introduced 60 years ago by Russel and Burch.

Rob Roggeband is the Industry co-chair of EPAA.

In almost 15 years, EPAA has contributed significantly to the advancement of 3Rs in toxicology. From the industry side, we have brought together the pharmaceutical, cosmetic, agrochemical, fragrance and detergent sectors and over the years we have learnt a lot from each other when it comes to regulatory toxicology.  After all, whether one does toxicology for medicine, a cosmetic or detergent, the basic principles of toxicology are applicable universally.  The advances in mechanistic understanding of the disease and biological processes leading to adverse outcomes have enabled us to make more informed safety decisions with the appropriate and right degree of conservatism built-in.

In 2019, EPAA organized three workshops, one on skin sensitization, one on carcinogenicity and one on repeated dose toxicity.  In these workshops, we bring leading scientists from academia, industry and regulators together to discuss and agree on how to make safety decisions in a risk assessment and a regulatory toxicology context.

These user fora have generated rich discussions that were integrated into peer-reviewed publications in the scientific literature.  After all, we are all interested in one thing, that is to make safety decisions for human safety using the best and state-of-the-art science, and the most relevant data on ingredients increasingly including data from non-animal alternatives.

We are in a world where “fear of chemistry” seems to be on the rise. The right experts in academia, industry and in the Competent Authorities must continue to work together to ensure confidence in human safety assessments including new generation risk assessments, or NGRA, those that are built on non-animal approaches to toxicology.

As EPAA looks ahead at its next 5-year Action Program for 2021-2025 we see an increasingly important role for NGOs in contributing to building consumer confidence in the safety of ingredients and safety assessments using non-animal approaches in toxicology based on mechanistic understanding of biological pathways in man.

Through the EPAA partnership and the so-called user fora of industry, regulators and academia we need to get increasingly comfortable to make safety decisions based on a weight of evidence of all available data, ideally without the generation of new animal data.  We need to move away from a default “checkbox” approach where we dose animals with unrealistically high levels of ingredients to only find ourselves having to explain why the effects observed at these very high doses are irrelevant in a human safety assessment context.

The alternative methods should not be validated against e.g. subchronic animal studies, as we risk losing many valuable and perfectly safe ingredients.  Instead, these alternative methods should drive better and more effective safety decisions.  New generation risk assessment approaches need to reflect, even more than in the past, the concept of exposure-based approaches, in contrast to establishing only the hazard potential of a chemical, in order to drive most relevant risk assessment decisions across sectors.

Indeed, the continued dialogue between academia, regulators and industry is the way forward and this is where the partnership in EPAA can play a unique role, in Europe but also globally, working towards the common goal: Better toxicology science with less and ultimately no new animal testing. It is time to think differently on animal alternative approaches.

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