Following a request from the European Commission, the European Food Safety Authority (EFSA) initiated a procedure for the evaluation of data supporting the necessity of the application of fungicide 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) which 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 according to the derogation detailed in Article 4(7) of Regulation (EU) No. 1107/2009 to assess the lack of other available means capable of controlling an identified serious danger to plant health. All the evaluations are performed separately for each specific crop/pathogen combination for which derogation is requested. Derogation for the use of a fungicidal active substance (a.s.) is not considered to be scientifically supported if an alternative control programme not requiring the application of a fungicide can manage the specific crop/pathogen combination under consideration; or if alternatively another a.s. from the same mode of action (MoA) as the a.s. under consideration is available (with the exception of the a.s. with unknown MoA). If these conditions are not verified, the process moves to the evaluation of: 1) the risk of resistance associated with the different MoA of all active substances for the specific crop/pathogen combination that are authorised in the MS; 2) the risk of resistance associated with the different pathogens; 3) the availability and durability of non-fungicide alternatives.
First published in EFSA Supporting Publications:
12 December 2017
24 November 2017