This session focused on emerging areas in biomedical research that are of key relevance to toxicology and, therefore, may influence EFSA 's work. The impact on the way risk assessment is conducted in the area of food may be through the identification of novel ways through which chemicals affect human health or through the provision of novel tools that could support regulatory assessment methods. Four topics were presented in this session. These covered areas such as epigenetics, proteomics, metabolomics and microbiomics, which are currently the subject of major research and development in systems biology and are beginning to impact on regulatory assessment approaches and methodologies. One emerging concept common to all four presentations was the importance of epigenetic changes, irrespective of whether development, neurodegeneration, ageing or cancer is considered. The epigenetic modulation of gene expression has profound effects on health and lifespan. Indeed, disruptions caused by environmental, dietary, pharmaceutical, microbial or lifestyle agents during pregnancy are key determinants responsible for major quantitative and qualitative changes in the epigenetic control of health and disease, either directly or indirectly through modulation of our gut microbiota. Although gut microbes provide energy to the body by helping in the breakdown of dietary components that are not degraded by our own digestive system, the intestinal microorganisms also produce important signalling molecules that regulate our systemic immune and metabolic responses and hence the microbiome can profoundly affect human physiology and health. A better knowledge of the different layers of information (genome, transcriptome, epigenome, proteome, metabolome and microbiome) will be paramount for our understanding of how environmental factors can impact on health and disease and will contribute to the regulatory assessment approaches and methodologies of the 21st century.