Revisiting EFSA@EXPO: beyond animal testing – reinventing chemical assessment
The safety assessment of chemicals is traditionally based on experimental animal tests. But society is increasingly resistant to this approach and the results are not always satisfactory. Regulatory toxicology has begun to embrace new hazard characterisation The second step in risk assessment, this involves defining the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. The process should, if possible, involve an understanding of the doses involved and related responses. approaches which could be integrated into regulatory safety assessments. The vision is to fundamentally change the way we assess the safety of chemicals, by superseding traditional animal experiments with a predictive toxicology that is based on a comprehensive understanding of how chemicals can cause adverse effects in humans.
Beyond animal testing: the frontiers of predictive toxicology
Keynote speaker Thomas Hartung, of John Hopkins University, made no bones about the issue: “Animal testing is not good enough,” he said. Complementing and gradually replacing this mainstay of traditional toxicological testing will not be easy but Prof Hartung mapped out some of the challenges and novel approaches emerging for assessing chemical hazards.
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Alternative and integrated testing strategies
Germany boasts one of the world’s first regulatory bodies for alternatives to animal testing (ZEBET) and Horst Spielmann, recently retired from Freie Universitat, Berlin, was its head until recently. An experienced scientific researcher and regulator, Prof. Spielmann detailed how integrated testing strategies that combine in vitro Research method which involves testing cells or tissues extracted from living organisms. (testing of cells or tissues, not whole animals) with previously performed in vivo Research method which involves testing individual live animals or populations of live animals. (tests on animals or humans) is already a reality for cosmetics regulation.
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Managing toxicological knowledge, information and data
The adverse outcome pathway A method of visualising a chain of events linked by causality that may lead to a harmful outcome for organisms or the environment. (AOP) concept provides a framework for managing our knowledge of the mode of action A sequence of events, identified by research, which explains an observed effect. of compounds that helps to weed out causality from the mass of available information. Ellen Fritsche of Leibniz Research Institute for Environmental Medicine, Germany, presented and put forward the AOP for positioning toxicity The potential of a substance to cause harm to a living organism. data generated by alternative methods in a regulatory context.
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Predictive toxicology: in vitro data and in silico models
The European Commission’s Joint Research Centre is leading Europe’s efforts to replace in vivo repeated dose The total amount of a substance (e.g. a chemical or nutrient) given to, consumed or absorbed by an individual organism, population or ecosystem. systemic toxicity testing. Its SEURAT project, explained Elisabet Berggren, aims to devise a toxicological mode-of-action framework to describe how any substance may adversely affect human health, and to use this knowledge to develop complementary theoretical, computational and experimental (in vitro) models for safety assessments.
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Simulating chemical effects
Computer simulations are being extensively used as support to human experts in evaluating chemical effects, explained Emilio Benfenati from Italy’s Istituto di Ricerche Farmacologiche Mario Negri. Computer processing power can perform quantitative structure-activity relationship analyses that integrated multiple approaches.
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A toxicological compound library
Scientific agencies in the US are working together to develop innovative approaches to characterise pathways of toxicity in chemical testing. Raymond Tice, of the US National Institute of Environmental Health Sciences (NIEHS), shed considerable light on the Tox21 Program. A vast toxicological compound library is being used as a source of information for predicting the likely responses of organisms when exposed to an array of chemicals, mainly used in pesticides. Presentation
“Lung-on-chip” generating human relevant data
Remi Villenave, from Emulate in the US, is using organs-on-chips technology to better understand mechanisms of diseases, study host pathogen Organism (e.g. bacterium, virus and parasite) that can cause disease. interaction and test new therapeutics. These 3D microfluidic cell chips reproduce living tissue and are already being used to simulate biological behaviour and generate data for testing medicines.
Promising developments but further work is needed
The speakers agreed that 3D cultures are evolving and promising, but the level of standardisation needs to be carefully considered to avoid additional uncertainty Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment. in their future uses. Large institutional databases will improve and increase the availability of data, and the transition to alternative testing methods needs to proceed faster. Enhanced dialogue and collaboration between regulators, academia and data providers (e.g. companies, laboratories) is crucial.
Moderated Panel Discussion
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