Ecological risk assessment and the regulation of chemicals: III. Balancing risks and benefits

Looking from both a scientific and legal background the authors suggest a model of how to decide about chemical substances in pre- or post-market regulation. The model reacts to the fact that whereas chemical substances abound, time and resources are scarce for gaining reliable information about the environmental impact. Often, uncertainties are inherent in the prediction of ecological effects. Risk analysis and assessment is broken down into an initial and a full-scale run. The initial run focusses on the intrinsic properties of the chemical substance and its metabolites. By application of exclusion criteria it may already lead to a positive or negative decision. Balancing risk against benefit, and comparing the benefit-risk ratios of the primary and of an alternative substance constitute further evaluative steps which again allow regulatory decisions. Substances which pass these steps and therefore are to be considered not clearly dangerous and comparatively beneficial are exposed to full-scale analysis. The evaluative steps are reiterated with regard to the outcome of this analysis.