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EFSA issued protocol for evaluating necessity of insecticide uses
Apr. 13, 2017
Following a request of the European Commission (EC), the European Food Safety Authority (EFSA) initiated a procedure for the evaluation of data concerning the necessity of the application of insecticide active substances (a.s.) to control serious dangers to plant health which cannot be contained by other available means, including non-chemical methods.
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 consistent and transparent evaluation of submissions made by applicants in accordance with 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 coordinator of the process, will ensure that the methodology is applied consistently, and will issue a scientific report on the evaluation of each insecticide 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 Organization (EPPO). The proposed methodology was also circulated among the EU Member States (MS) for commenting, and hence also their suggestions were assessed by the WG and taken into account where applicable.
The applicant requesting a derogation under Article 4(7) of Regulation (EC) No 1107/2009 should include in their dossier: information, data and evidence to demonstrate that the substance is necessary to control a serious danger to plant health that cannot be sufficiently contained by any other available means including non-chemical methods, following the methodology and harmonised template presented in this report. The information should be provided for each specific crop/pest combination separately, at national level for which a derogation is applied.
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 to each specific crop/pest combination separately, at national level for which a derogation is applied. The process starts by checking whether another a.s. with the same mode of action (MoA) as the a.s. under consideration is available.
In this case, derogation is usually not scientifically supported. Likewise, if a non-insecticide control programme (that can include the use of semiochemicals) is sufficient to manage the pest/crop combination under consideration, derogation would be considered as not being scientifically supported. Otherwise the process moves to the evaluation of: 1) the risk of resistance associated to the different MoA of all a.s. that are authorised in the MS; 2) the risk of resistance associated with the different pests; 3) the non-insecticide alternatives. Data on the combined resistance risk and the evaluation of non-insecticide alternatives will support the risk management decision.
Source: EFSA
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