Risk assessment of chemicals and their mixtures are hindered by scarcity and inconsistencies between different environmental exposure limits

Abstract

In chemical risk assessment, measured or modelled environmental concentrations are compared to environmental exposure limits (EELs), such as Predicted No Effect Concentrations (PNECs) or hazardous concentrations for 5% of species (HC05s) derived from species sensitivity distributions (SSDs). However, for many chemicals the EELs include large uncertainties or, in the worst case, the necessary data for their estimation are completely missing. This makes the assessment of chemical risks and any subsequent implementation of management strategies challenging. In this study we analyzed the uncertainty of EELs and its impact on chemical risk assessment. First, we compared three individual EEL datasets, two primarily based on experimental data and one based on computational predictions. The comparison demonstrates large disagreements between EEL data sources, with experimentally derived EELs differing by more than seven orders of magnitude. In a case-study, based on the predicted emissions of 2005 chemicals, we showed that these uncertainties lead to significantly different risk assessment outcomes, including large differences in the magnitude of the total risk, risk driver identification, and the ranking of use categories as risk contributors. We also show that the large data-gaps in EEL datasets cannot be covered by commonly used computational approaches (QSARs). We conclude that an expanded framework for interpreting risk characterization outcomes is needed. We also argue that the large data-gaps present in ecotoxicological data need to be addressed in order to achieve the European zero pollution vision as the growing emphasis on ambient exposures will further increase the demand for accurate and well-established EELs.

Keywords: Chemical mixtures; Chemical risk assessment; Hazard assessment; Predicted No Effect Concentrations; SimpleTreat.