Assuring safety without animal testing: Unilever’s ongoing research programme to deliver novel ways to assure consumer safety

Abstract

Assuring consumer safety without the generation of new animal data is currently a considerable challenge. However, through the application of new technologies and the further development of risk-based approaches for safety assessment, we remain confident it is ultimately achievable. For many complex, multi-organ consumer safety endpoints, the development, evaluation and application of new, non-animal approaches is hampered by a lack of biological understanding of the underlying mechanistic processes involved. The enormity of this scientific challenge should not be underestimated. To tackle this challenge a substantial research programme was initiated by Unilever in 2004 to critically evaluate the feasibility of a new conceptual approach based upon the following key components: 1. Developing new, exposure-driven risk assessment approaches 2. Developing new biological (in vitro) and computer-based (in silico) predictive models 3. Evaluating the applicability of new technologies for generating data (e.g. "omics", informatics) and for integrating new types of data (e.g. systems approaches) for risk-based safety assessment Our research efforts are focussed in the priority areas of skin allergy, cancer and general toxicity (including inhaled toxicity). In all of these areas, a long-term investment is essential to increase the scientific understanding of the underlying biology and molecular mechanisms that we believe will ultimately form a sound basis for novel risk assessment approaches. Our research programme in these priority areas consists of in-house research as well as Unilever-sponsored academic research, involvement in EU-funded projects (e.g. Sens-it-iv, Carcinogenomics), participation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientific initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US "Human Toxicology Project" consortium).

A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing

“…Alternative approaches as one-by-one replacements of animal tests have advanced over the last two decades, and formal validation has delivered the proof-of-principle that they do not lower safety standards (Westmoreland et al, 2010). Increasingly, international acceptance of these methods is being achieved.…”

A Next-Generation Risk Assessment Case Study for Coumarin in Cosmetic Products

“…The ambition to conduct human health risk assessments without generating new animal data has resulted in intense efforts over the past few decades from industry, academia, and regulatory bodies to develop and apply new approach methodologies (NAMs) that can form the basis of integrated testing and assessment strategies designed to prevent harm to human health ( Carmichael et al , 2009 ; Council, 2007 ; Desprez et al , 2018 ; Thomas et al , 2019 ; Westmoreland et al , 2010 ). The momentum created by these efforts has led to a number of studies that employed 1 or more NAMs in risk assessment.…”

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

“…The Unilever team published a suggested future direction in 2004, 13 and this was the initial basis for re-thinking our approach to assessing consumer safety without new animal testing. [14][15][16] Over the past 15+ years, we have leveraged the best new science and technology and expertise available, in partnership with leading scientists globally, to transform how we apply next generation science and a non-animal toolbox (based on NAMs) to make decisions on the safety of products used by billions of consumers across the world every day. 6,10,15 We have published and presented our research outputs, and made these publicly available via a dedicated Safety Sciences in the 21st Century website, 16 and have discussed the non-animal science and assessment approaches we now use with scientists working in academia, governments, non-governmental organisations and other companies.…”