Dec. 20, 2017
Following a request of the European Commission (EC), the European Food Safety Authority (EFSA) initiated a procedure for the evaluation of data on concerning the necessity of the application of fungicide active substances (a.s.) to control a serious danger to plant health that cannot be contained by other available means, including non-chemical methods within the context of Article 4(7) of Regulation (EC) No. 1107/2009.
EFSA established an ad hoc working group (WG) to develop a methodology for conducting such type of evaluation. 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 (EC) No. 1107/2009 to confirm the lack of other available means capable of controlling an identified serious danger to plant health.
EFSA will act as the co-ordinator of the process, will ensure that the methodology is applied consistently, and will issue a scientific report on the evaluation of each fungicide a.s. for which derogation under Article 4(7) of Regulation (EC) No. 1107/2009 is requested. The protocol takes into account relevant international standards from the European and Mediterranean Plant Protection Organisation. The proposed methodology was also circulated among the European Member States (MS) for comment, and hence also their suggestions were assessed by the WG and taken into account where applicable.
The MS will verify the information provided by the applicant and will provide supplementary information, data and evidence from their respective countries and may include other uses that were not requested by the applicant e.g. Article 51 extensions of minor use.
The MS will evaluate the overall information based on the following methodology applied separately at national level to each specific crop/pathogen combination, for which a derogation is requested. The process starts by checking whether another a.s. from the same mode of action (MoA) as the a.s. under consideration is available. In this case derogation is considered not to be scientifically supported. Likewise, if a non-fungicide control programme (that can include e.g. the use of resistance inducers or biological control agents) is sufficient to manage the pathogen/crop combination under consideration, derogation would be considered as not scientifically supported.
Otherwise the process moves to the evaluation of: 1) the risk of resistance associated with the different MoA of all a.s. that are authorised in the MS; 2) the risk of resistance associated with the different pathogens; 3) the non-fungicide alternatives. Data on the combined resistance risk and the evaluation of non-fungicide alternatives will support the risk manager decision.