Although the potential use of biomarkers within environmental risk assessment (ERA) has long been recognised their routine use is less advanced compared with clinical human health risk assessment, where a number of familiar biomarkers (such as blood pressure and serum cholesterol) are in common usage. We have examined how biomarkers are incorporated into human health risk assessment and have identified several ‘required elements’. These include identification of the (clinical) assessment endpoint at the outset, rational selection of the biomarker(s) (the measurement endpoint), biomarker ‘validation’ (e.g. QA/QC) and biomarker ‘qualification’ (evidence linking the measurement and assessment endpoints). We discuss these elements in detail and propose that their adoption will facilitate the routine use of biomarkers in environmental risk assessment. Furthermore, our analysis highlights the need for cooperation between those working with biomarkers within human and environmental risk assessment to exchange best practice between common disciplines for mutual advantage.