Human Pharmaceuticals

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Human pharmaceuticals may enter the environment from two main sources: effluent discharge into surface waters from sewage treatment plants (STPs) and from STP sludge applied to land. The potential for contamination of soil, surface and groundwater has to be investigated as well as a consideration of possible effects on non-target terrestrial and aquatic species.

Within Europe, new guidance document from the European Medicines Agency (EMEA) was publiched in June detailing a tiered approach to environmental hazard/risk assessment coupled with associated tiers of data requirements in the context of product licensing. The document can be found at:

The risk assessment is divided into a Phase I exposure assessment and a Phase II analysis of fate and effects subdivided into Tier A (base set data an initial environmental fate and effects analysis) and, Tier B (more detailed fate and effects data requirements and refined exposure and risk assessment).

CEA has competence in exposure characterisation and in the determination of Predicted Environmental Concentrations (PECs) in environmental compartments. We advise on critical fate and effects studies and conduct full risk assessments.