Protocol for the evaluation of data concerning the necessity of the application of insecticide active substances to control a serious danger to plant health which cannot be contained by other available means, including non-chemical methods
This version replaces the early version which was published on 5 April 2017 and updated on the 5 June 2017. The text of one element of the flow chart in Appendix A was modified.
Following a request from the European Commission (EC), the European Food Safety Authority (EFSA) initiated a procedure for the evaluation of data supporting the necessity of the application of insecticide active substances to control a serious danger to plant health within the context of Article 4(7) of Regulation (EC) No 1107/2009. EFSA established an ad hoc working group (WG) who proposed a methodology for conducting this type of evaluation. The draft protocol was circulated among European Union Member States (MS) for commenting. The aim of this protocol is to enable a consistent and transparent evaluation of submissions made by applicants in accordance with the derogation detailed in Article 4(7) of Regulation (EU) No 1107/2009 to confirm the lack of other available means capable of controlling an identified serious danger to plant health. All the evaluations are made for each specific crop/pest combination separately for which a derogation is requested. Usually, derogation for the use of an insecticide active substance is not scientifically supported if an alternative control programme not requiring the application of an insecticide can manage the specific crop/pest combination under consideration, or if another active substance with the same mode of action (IRAC) as the active substance under consideration is available. If these conditions are not verified, the process moves to the evaluation of: 1) the risk of resistance associated to the different mode of action of all active substances that are authorised in the MS; 2) the risk of resistance associated to the different pests; 3) the availability of non-insecticide alternatives.