Pymetrozine was included in Annex I to Directive 91/414/EEC1 on 1 November 2001 and has been deemed to be approved under Regulation (EC) No 1107/20092 , in accordance with Commission Implementing Regulation (EU) No 540/20113 , amended by Commission Implementing Regulation (EU) No 2017/8414 , as regards the extension of the approval period for pymetrozine to 30 June 2018.
The applicant, Syngenta Crop Protection AG, applied for renewal of approval in line with the provisions of Commission Regulation (EU) No 1141/20105 as amended by Commission Implementing Regulation (EU) No 380/20136 . Pymetrozine was evaluated by Germany as rapporteur Member State (RMS). The RMS delivered its initial evaluation of the dossier in the Renewal Assessment Report (RAR), which was received by EFSA on 28 June 2013 (Germany, 2013). In accordance with Article 16 of Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013, EFSA finalised the conclusion on the peer review of the pesticide risk assessment of pymetrozine on 22 August 2014 (EFSA, 2014).
In 2014, during the peer review, EFSA proposed to classify pymetrozine as toxic for reproduction category 2 (R2) in addition to the harmonised classification as carcinogen category 2 (C2). A critical area of concern was identified with regard to the approval criteria of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 interim provisions for active substances that shall be considered to have endocrine disrupting properties. In September 2016, EFSA was requested by the European Commission to carry out an assessment of the information submitted by the applicant to demonstrate whether the active substance pymetrozine can be used such that exposure to humans may be considered negligible. EFSA finalised the peer review in light of negligible exposure data on 12 December 2016 (EFSA 2017a).
The applicant Syngenta Crop Protection AG requested derogation in accordance with the provisions of Article 4(7) of Regulation (EU) 1107/2009, submitting evidence regarding the necessity of pymetrozine to control a serious danger to plant health which cannot be contained by other available means. In January 2016, European Commission requested by a general mandate to EFSA to provide scientific assistance as regards the consideration of evidence that the application of an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods. In order to address this request EFSA set up a working group (WG) to develop a specific methodology for the assessment of insecticide active substances (a.s.). The protocol on the methodology was published on published 29 March 2017 (EFSA, 2017b).
Subsequently, the applicant was requested by European Commission to re-submit the data following the methodology developed by EFSA. On 7 June 2017 EFSA received the updated submission provided by the applicant, consisting in a data collection set and a report (Syngenta, 2017a,b). The applicant included claims that the use of pymetrozine is considered essential in accordance with Article 4(7) of Regulation (EC) No 1107/2009 in relation to the uses (more than 150 pest-crop combinations) authorised in 17 Member States (MS) (Austria, Belgium, Croatia, the Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands, Poland, Portugal, Slovenia, Spain, Sweden, and the United Kingdom).
On 26 June 2017 EFSA launched a ten weeks commenting phase asking all MS to confirm that the uses for which the applicant requests Article 4(7) derogation are authorised and if the use of pymetrozine is considered essential to control a serious danger to plant health, giving clear justification for each use that is considered as critical. In addition, all MS were invited to supplement the information provided by the applicant with information from their own MS uses also considering other uses not presented by the applicant (e.g. minor uses). During the commenting phase 9 MS (Austria, Belgium, Denmark, Finland, France, Germany, the Netherlands, Spain, and the United Kingdom) validated the information provided by applicant and 1 MS (Latvia) submitted new information in relation to the uses in oilseed rape. As a follow up, EFSA ensured that the methodology was consistently applied by MS and summarised the evaluation of pymetrozine (See Appendix A) in the current scientific report. A final consultation process with MS on the draft scientific report was launched in October 2017. The legal deadline to finalise the current scientific report is 7 December 2017
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