INTRODUCTION. Joining forces for the replacement of animal studies in food sciences

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1 INTRODUCTION Joining forces for the replacement of animal studies in food sciences

2 Background - science Rapid advances in scientific knowledge e.g. genomics, exposure science Toxicology is moving away from whole-animal approaches to one based on mechanistic understanding Huge technological advances e.g. HTS, informatics, comp. tox.

3 Background - science Scientific value of animal studies being challenged Speed of innovation creating novel materials e.g. nano, biotechnology Too many chemicals not enough animals/money/time!

4 Background stakeholders Consumers Regulators Consumers are increasingly unwilling to accept animal testing for food safety/ nutrition In 1980s EU committed to replace AT 86/609/EEC development and validation of alternatives 2010/63/EU principles of 3Rs FDE Congress one of the most pressing priorities is alternatives to animal testing - there needs to be change in culture EFSA communicating a need for change in attitude to animal testing. Indicators of regulatory change - Cosmetic testing bans - EFSA review modern methodologies and tools (EFSA, 2014) - USFDA Redbook undergoing major review

5 THE DILEMMA A need for safety and nutritional decisions to be made on the basis of the best scientific approaches In this rapidly developing world the best science is not necessarily reliant on new data generated from animals

6 Regulatory & Scientific Inertia Often there may be a regulatory precedent for animal testing even though it may not be scientifically justified Scientific committees expect to see animal data even if there may not be a regulatory requirement

7 Important to Collaborate & Form Stakeholder Partnerships ACADEMIA CONSUMER TRUST GOVERNMENT /REGULATORS INDUSTRY

8 The Opportunity An emerging issue for Foods and Beverages ILSI Europe address this global challenge by initiating an activity that encompasses both safety and nutritional / efficacy issues surrounding animal testing and foods/ beverages

9 Alternatives to Animal Testing Task Force Objectives Communicate to stakeholders on the development of alternative strategies in this area. Review and assess the recently developed methods and provide evidence-based science on their potential use and limitation, and assess when these methods could ultimately replace animal testing. Build a global consensus on how and what is needed to reduce animal testing in food and beverage development

10 Expert Group Holistic Approaches to Develop Alternative Strategies to Animal Testing in Food Safety, Nutrition and Efficacy Studies Review the case for animal testing for foods from both a safety and nutritional/ efficacy perspective and when it can be avoided/ replaced. Communication to stakeholders alternative strategies peer reviewed publications, workshops.

11 Task Force: Alternatives to Animal Testing Task Force member Dr Paul Hepburn - Chair Dr Rocio Fernández Cantón Vice Chair Dr Cyrille Krul Co Chair Dr Markus Fehr Ms Caroline Perreau Dr Katrin Schütte Dr Sylvain Etter (member co-rep.) Dr Constanze Stiefel Dr Vassilis Triantis Dr Johanneke van der Harst Dr Jan van der Valk Dr Lucie Geurts Affiliation Unilever Monsanto Europe University of Applied Sciences DSM Roquette European Commission Firmenich WALA Heilmittel Friesland Campina Danone 3R-Centre Utrecht Life Sciences ILSI Europe

12 Expert Group: Holistic Approaches to Develop Alternative Strategies that do not rely on Additional Animal Testing Task Force member Affiliation Country Dr Vassilis Triantis - Chair Friesland Campina NL Dr Maria Tabernero Urbieta Vice Chair IMDEA Food ES Dr Markus Fehr DSM CH Ms Laura Caneva Monsanto Europe BE Dr Paul Hepburn Unilever UK Dr Nynke Kramer University Utrecht NL Dr Katrin Schütte European Commission BE Dr Johanneke van der Harst Danone NL Prof Koen Venema University of Maastricht NL Prof Bob van de Water Leiden University NL Dr Lucie Geurts ILSI Europe BE

13 Expert Group: Holistic Approaches to Develop Alternative Strategies that do not rely on Additional Animal Testing Objectives 1. Review food safety, efficacy and nutritional regulations and summarise these existing regulations 2. Develop an overview of the existing tools or methodologies that could be applied to food safety, nutrition and efficacy assessments and do not involve animal testing 3. Verify whether these tools and methodologies can be applied to the current regulations in food safety and nutrition. This project will thus identify existing tools and approaches which are not reliant on generating data in animals to address those requirements.

14 Upcoming Activities - Future Topics of Interest Dissemination/ peer reviewed publication New potential activities should be identified from the workshop Workshop holistic approaches (Sept 2018)

15 Upcoming Activities One ILSI Initiative One ILSI Interest from several ILSI branches Opportunity to leverage the project impact Build a global initiative International Workshop 2019 Aim: share worldwide and suggest some approaches

16 Manuscript Outline Introduction food safety testing Food supplements Food additives Food enzymes Food flavors Nutritional health claims Infant formulae Foods for special medical purposes Novel foods GMOs Tools and methodologies Conclusion

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