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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
See other projects for this call

Funding Scheme

STREP - Specific Targeted Research Project

Coordinator

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

Participants (15)

AARHUS UNIVERSITET
Denmark
Address
Nordre Ringgade 1
Aarhus C
ASTRAZENECA UK LTD
United Kingdom
Address
Stanhope Gate 15
London
BRUNEL UNIVERSITY
United Kingdom
Address
Kingston Lane
Uxbridge
BUNDESANSTALT FUER GEWAESSERKUNDE
Germany
Address
Am Mainzer Tor 1
Koblenz
CANADIAN WATER NETWORK
Canada
Address
200 University Avenue West
Waterloo, Ontario
CENTRE NATIONAL DU MACHINISME AGRICOLE, DU GENIE RURAL, DES EAUX ET DES FORETS
France
Address
Parc De Tourvoie
Antony
DANMARKS FARMACEUTISKE UNIVERSITET
Denmark
Address
Noerregade 10
Kobenhavn
DANMARKS MILJOEUNDERSOEGELSER
Denmark
Address
Frederiksborgvej 399
358 Roskilde
EAWAG - EIDGENOESSISCHE ANSTALT FUR WASSERVERSORGUNG ABWASSERREINIGUNG UND GEWAESSERSCHUTZ
Switzerland
Address
Ueberlandstrasse 133
Duebendorf
GEOTECHNISCHES INSTITUT AG
Switzerland
Address
Gartenstrasse 13
Bern
INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA
Spain
Address
Carretera De La Coruna Km7.5
Madrid
KOBENHAVNS UNIVERSITET
Denmark
Address
Noerregade 10
Kobenhavn
UMWELTBUNDESAMT
Germany
Address
Woerlitzer Platz 1
Dessau
UNIVERSITEIT UTRECHT
Netherlands
Address
Heidelberglaan 8
Utrecht
UNIVERSITY OF YORK.
United Kingdom
Address
Heslington
York