The overall objective of ERAPharm is to improve and complement existing knowledge and procedures for theenvironmental risk assessment (ERA) of human and veterinary pharmaceuticals. Based on EU regulatoryframeworks on the ERA of pharmaceuticals and on the outcome of previous projects ERAPharm will address thefollowing aspects:It will investigate previously unstudied major routes leading to exposure of the terrestrial and aquaticenvironment and subsequent fate of pharmaceuticals in surface water and sediment. Factors and processesaffecting the behavior of pharmaceuticals in the environment will be studied on the laboratory, semi-field and fieldscale. A scenario-based exposure assessment system will be developed for predicting concentrations of pharmaceuticals in soils, surface waters and sediments and leaching to groundwater. It will be investigated if environmentally relevant concentrations of pharmaceuticals pose a risk to aquatic and terrestrial organisms. Pharmaceuticals and selected transformation products will be screened using in vitro and low complexity bioanalytical tests in order to provide a first hazard characterization and to target higher tier testing. Higher tier test methods will be improved and applied for detecting the effects of long-term, low-levelexposure to pharmaceuticals on aquatic and terrestrial invertebrates and fish. It will be evaluated if information on pharmaco- and toxicodynamics in mammalian species can be used to predict effects of pharmaceuticals on environmental organisms. Moreover, the effects of antibiotics on microbial communities will be studied with a main focus on the spread of genetically encoded resistance. Based on the developed approaches recommendations will be provided on how to improve the ERA proceduresfor pharmaceuticals. A guidance document will be compiled that will be made available to regulators, industry andthe scientific community.
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