Peer review of the pesticide risk assessment of the active substance trifloxystrobin

Abstract

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the United Kingdom, and co-rapporteur Member State, Greece, for the pesticide active substance trifloxystrobin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of trifloxystrobin as a fungicide on apple, pear, quince, grapes and strawberry. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. In accordance with Article 1 of the Regulation, the rapporteur Member State (RMS), the United Kingdom, and co-rapporteur Member State (co-RMS), Greece, received an application from Bayer CropScience AG for the renewal of approval of the active substance trifloxystrobin. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Greece), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.The RMS provided its initial evaluation of the dossier on trifloxystrobin in the renewal assessment report (RAR), which was received by EFSA on 29 September 2016. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Bayer CropScience AG, for comments on 10 November 2016. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 12 January 2017.Following consideration of the comments received on the RAR, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology.In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether trifloxystrobin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council.The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of trifloxystrobin as a fungicide on field application on apple, pear, quince, grapes, and greenhouse and field applications in strawberry, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.Data were submitted to conclude that the ...

Modification of existing maximum residue levels in various crops and evaluation of confirmatory data following the Article 12 MRL review for trifloxystrobin

“…Trifloxystrobin was evaluated in the framework of Regulation (EC) No 1107/2009 1 with United Kingdom designated as rapporteur Member State (RMS) for the representative uses (foliar applications) on apples, pears, quinces, grapes and strawberries. The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA ( 2017 ). The approval of trifloxystrobin for the use as fungicide was renewed 2 on 1 August 2018.…”

“…EFSA based its assessment on the evaluation report submitted by the EMS the Netherlands (Netherlands, 2021a , b ) the renewal assessment report (RAR) and its revision (United Kingdom, 2016 , 2017 ) prepared under Regulation (EC) No 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance trifloxystrobin (EFSA, 2017 ), the Commission review report on trifloxystrobin (European Commission, 2018 ) as well as the conclusions from previous EFSA opinions and scientific reports on trifloxystrobin, including the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2014a , b , 2016a , b , 2018c , d , 2019b ).…”

Modification of the existing maximum residue level for trifloxystrobin in broccoli

“…Trifloxystrobin was approved for the use as a fungicide on 1 October 2003. The process of renewal of the first approval with the United Kingdom designated as rapporteur Member State (RMS) for the representative uses on apple, pear, quince, grapes and strawberry has been completed (EFSA, ). Trifloxystrobin renewal was approved on 1 August 2018…”

“…In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 and the renewal of the approval under Regulation (EC) No 1107/2009 (EFSA, , ), the metabolism of trifloxystrobin following foliar treatment was investigated in primary crops belonging to the groups of fruits and fruiting vegetables (apple, cucumber), root and tuber vegetables (sugar beet), cereals (wheat) and pulses and oilseeds (peanut). In the metabolism studies, the parent compound was the major component of the total radioactive residues (TRR) in all crops.…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Greece, 2018), the renewal assessment report (RAR) (and its revision) (United Kingdom, 2016, 2017) prepared under Regulation (EC) 1107/2009 8 , the conclusion on the peer review of the pesticide risk assessment of the active substance trifloxystrobin (EFSA, 2017), the Commission review report on trifloxystrobin (European Commission, 2018), as well as the conclusions from previous EFSA opinions on trifloxystrobin including the one on the MRL review (EFSA, 2014a(EFSA, ,b, 2016(EFSA, , 2018 For this application, the data requirements established in Regulation (EU) No 283/2013 9 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a-g, 2000, 2010a,b, 2017OECD, 2011OECD, , 2013. The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 10 .…”