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Environmental risk assessment of pharmaceuticals

Objective

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.

Call for proposal

FP6-2003-GLOBAL-2
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Coordinator

ECT OEKOTOCXIKOLOGIE GMBH
Address
Bottgerstraße, 2-14
D-65439 Flörsheim
Germany

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Participants (15)

AARHUS UNIVERSITET
Denmark
Address
Nordre Ringgade 1
Aarhus C

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ASTRAZENECA UK LTD
United Kingdom
Address
Stanhope Gate 15
London

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BRUNEL UNIVERSITY
United Kingdom
Address
Kingston Lane
Uxbridge

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BUNDESANSTALT FUER GEWAESSERKUNDE
Germany
Address
Am Mainzer Tor 1
Koblenz

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CANADIAN WATER NETWORK
Canada
Address
200 University Avenue West
Waterloo, Ontario

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CENTRE NATIONAL DU MACHINISME AGRICOLE, DU GENIE RURAL, DES EAUX ET DES FORETS
France
Address
Parc De Tourvoie
Antony

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DANMARKS FARMACEUTISKE UNIVERSITET
Denmark
Address
Noerregade 10
Kobenhavn

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DANMARKS MILJOEUNDERSOEGELSER
Denmark
Address
Frederiksborgvej 399
358 Roskilde

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EAWAG - EIDGENOESSISCHE ANSTALT FUR WASSERVERSORGUNG ABWASSERREINIGUNG UND GEWAESSERSCHUTZ
Switzerland
Address
Ueberlandstrasse 133
Duebendorf

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GEOTECHNISCHES INSTITUT AG
Switzerland
Address
Gartenstrasse 13
Bern

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INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA
Spain
Address
Carretera De La Coruna Km7.5
Madrid

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KOBENHAVNS UNIVERSITET
Denmark
Address
Noerregade 10
Kobenhavn

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UMWELTBUNDESAMT
Germany
Address
Woerlitzer Platz 1
Dessau

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UNIVERSITEIT UTRECHT
Netherlands
Address
Heidelberglaan 8
Utrecht

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UNIVERSITY OF YORK.
United Kingdom
Address
Heslington
York

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