Biomonitoring is a powerful tool to assess exposure to a wide variety of substances. It is superior to many other exposure assessment methodologies since it allows assessment of the actual exposure on the individual level. For decades, biomonitoring has been applied in occupational settings to assess exposure, with the main goal of checking for compliance with occupational exposure limits and the effectiveness of hygienic measures. Increasing analytical capabilities have led to continuously decreasing limits of detection, and have hence opened up biomonitoring for environmental exposure assessment. When biomonitoring is not simply used as exposure monitoring in occupational settings, but rather to assess human health risks either in the workplace or for the general public, specific criteria must be met. These criteria cover (pre‐) analytical methodology, specificity of the biomarker, dose–response relationships, toxicokinetics (e.g. biological half‐life) and reference values or control groups. If any of these criteria cannot be met, more research is needed before a valid health risk assessment can be made. Risk assessment is a function of hazard and exposure over time. A major problem in health risk assessment is the general lack of knowledge about low‐dose‐effect relationships, which prevents a reliable health risk assessment at the low exposure levels commonly found. Toxicogenomics may provide useful data to fill these voids. In addition to scientific criteria, a number of nonscientific and ethical criteria for biomonitoring studies should be addressed, such as the feasibility, the cost/benefit balance, support by the people involved, and the possibility of intervention (e.g. individual treatment, environmental measures, behavioural changes).