Environmental risk assessment of veterinary medicinal products in the EU--a regulatory perspective.

The pharmacological nature of veterinary medicinal products, frequent application rates and use on a large scale for livestock production sensitizes regulation authorities for environmental concern. Consequently, in the European Union legal requirements plus guidance for an Environmental Risk Assessment of veterinary pharmaceuticals have been established. Applicants of new veterinary medicinal products have to provide an ecotoxicity report according to a guidance document which rests upon a logical, tiered approach with a cut-off trigger between a basic characterisation of the veterinary medicinal product and an in-depth assessment of its fate and ecotoxic effects. The outcome of this assessment is the establishment of the environmental risk that may arise from the use of the VMP under question. Contamination of the environment can be reduced by appropriate risk mitigation measures, e.g. limiting the application rate, the amount of contaminated manure being spread on agricultural lands or the access of treated pasture animals to surface waters.