Evaluation of Ecotoxicological Field Studies for Authorization of Plant Protection Products in Europe

Abstract

ABSTRACT An increasing number of ecotoxicological field studies are being submitted in the European Union procedure for authorization of pesticides. Although there is some guidance on how these studies can be used for risk assessment, not all aspects of field tests are covered and the guidance differs per type of test and per non-target group. To facilitate a more uniform approach by the regulatory authorities in the EU, a basic scheme is proposed with qualitative tools to: (i) assess the scientific reliability of individual field tests, and (ii) to assess the usefulness of field tests for regulatory risk assessment of the pesticide under registration. In this way, the treatment, evaluation, and the mutual comparability of field data for regulatory purposes is harmonized. It thereby provides a more consistent foundation for further risk assessment.