W8 PM Ecotoxicology of Agrochemicals and Pharmaceuticals
Wednesday, 16 November 2005: 1:50 PM - 5:30 PM in 337-338

(AAA-1117-814259) Environmental risk assessment of feed additives and veterinary medicina products - A regulatory perspective.

De Knecht, J.A.¹, ¹ RIVM, Bilthoven, The Netherlands

ABSTRACT- The presentation outlines the risk models for feed additives and veterinary medicinal products (VMPs) medicines applied at registration in the European Union. The decision-making criteria for the environmental risk assessment (ERA) of feed additives are given in Directive 2001/79/EC. The assessment includes a tiered approach based on two phases and is comparable to the assessment for VMPs described in the 1997 CVMP/EMEA Note for Guidance. Phase I evaluates the extent of environmental exposure and eliminates those products, where the extent of exposure is low, from the need for further assessment. For the products remained a complete phase II risk assessment is required, for which the applicant has to provide data on the environmental fate and effects of the residue on the environmental impact of concern. For VMPs the working group of the Veterinary International Co-operation of Harmonization (VICH) recently developed new guidelines for both phases in order to achieve harmonization between Europe, USA, Japan and Australia/New Zealand on the data requirements for registration. Once implemented, these guidelines will replace the CVMP/EMEA Note for guidance (foreseen in 2005-2006). Since the guidelines do not give technical guidance for predicting the environmental concentrations of feed additive and VMPs, technical guidance documents are now under construction by EFSA and EMEA. Specific aspects of the exposure assessment will be highlighted. The cocciodiostats used as feed additives will serve as case studies.

Key words: veterinary drugs, environmental risk assessment, feed addtives