Do new generations of active pharmaceuticals for human use require an adaption of the environmental risk assessment? - Part I: Literature review

Pharmaceuticals can be a problem for the environment and its inhabitants. Several hundred active pharmaceutical ingredients were already found in the ng/L to μg/L range in surface water, groundwater, or soil. To date, all pharmaceutical which exceed an action limit of 0.01 μg/L in the environment are subjected to an environmental risk assessment. However, there is the risk that some of the pharmaceuticals are effective even at lower concentrations, or that the guideline does not recommend studies with the most sensitive test organism for the respective mode of action. In order to answer this question, the current project focussed on the identification of active pharmaceutical ingredients approved since 2006, as well as on the summary of relevant information for these substances. Based on these data, three substance classes were chosen, which contribute most to the high number of pharmaceuticals in the environment, i.e. ‘neurology’, ‘cardiology’, and ‘oncology’. The literature review furthermore identified sensitive ecotoxicological test systems, based on data obtained for substanceclass specific model substances. Finally, five substances per group were chosen for testing the alternative test systems. Requirements for the chosen test substance were the availability of an ERA according to the EMA guideline as well as information on the effects of a model substance with similar mode of action in the alternative test systems. Based on experimentally obtained data it should be determine, if a tailored risk assessment is suitable for the selected substance class or if studies according to the EMA guideline are sufficiently predictive for an environmental risk assessment.