Risk assessment of biopesticides in the light of the EU Directive 91/414: Revision of the guidelines for the biopesticides and problems arising from the comparison to chemicals

Following the activity of the "ad hoc" group of the National Consultant Com mittee on plant Protection Products, the problems arising for the applicati on of the EU Directive 91/414 for new and existing (revision) biopesticides are reported. The requests provided for the registration of new micro-orga nisms or for the revision of existing biopesticides were initially the same provided for chemicals. Difficulties arose in the application of the guidelines, yielding to revise the data requirements for risk assessment (Annex II part B and Annex III p arr B) in the light of the emergent problems due to the obvious differences between the two category of substances (chemical and micro-organism-based pesticides), and between the possible overlay of Dir 91/414 and Dir 90/220 about genetically modified organisms. Different needs are reported regardin g the critical end points such as mode of action, characterisation, toxicol ogical and microbiological features, and the problems related to the use an d handling of these products as well as the new input to develop more suita ble strategies for an appropriate risk assessment of these products.