Altex 27, 3/10 207 Westmoreland et al. 1 Introduction Unilever’s commitment to eliminating animal testing has been un- derpinned by our scientifc research programme since the 1980’s in developing and using alternatives to animal tests. Since 2004, we have invested an additional € 3 million a year towards the develop- ment of novel non-animal approaches to assure consumer safety. Unilever’s conceptual framework for safety assurance is risk-based rather then hazard-based, meaning all available data on a new in- gredient (including predicted levels of consumer exposure during product use) are analysed using a weight-of-evidence approach to judge the level of risk prior to generating any new data to further characterise the hazard. Our research efforts are currently focussed on the develop- ment and evaluation of new risk assessment approaches for as- suring consumer safety in the areas of skin allergy (Maxwell et al., 2008) and cancer, and consideration of how risk-based approaches and the application of new models and technologies could be applied in the area of general toxicity (where we have used inhaled toxicity as a specifc case study). The scientifc and technical challenges associated with assuring consumer safety without any animal testing in the ar- eas outlined above are enormous and it is clear that no single research group or company will achieve these goals alone. For this reason, in order to develop alternative approaches for con- sumer safety, Unilever has its own in-house research programme and in addition works in partnership with a number of external groups. these partnerships include sponsoring research with academic institutions, investigating new approaches with con- tract research organisations, initiating bespoke research with biotechnology companies, and consultancies with key experts. In addition to our internal research programme we are also in- Assuring Safety without Animal Testing: Unilever’s Ongoing Research Programme to Deliver Novel Ways to Assure Consumer Safety Carl Westmoreland, Paul Carmichael, Matt Dent, Julia Fentem, Cameron MacKay, Gavin Maxwell, Camilla Pease and Fiona Reynolds Safety & environmental Assurance Centre (SeAC), Unilever, Bedford, UK Summary 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 approach- es for safety assessment, we remain confdent 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 scientifc 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 scientifc 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), par- ticipation in cross-industry collaborative research (e.g. Colipa, EPAA) and ongoing involvement with other scientifc initiatives on non-animal approaches to risk assessment (e.g. UK NC3Rs, US “Human Toxicology Project” consortium). Keywords: risk assessment, skin allergy, cancer, Colipa, NC3Rs, European Commission, EPAA Lecture held at the 7 th Worldcongress in Rome 2009