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

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, Latvia, and co-rapporteur Member State, France, for the pesticide active substance zoxamide 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 zoxamide as a fungicide on wine and table grapes, and potatoes. 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), Latvia, and corapporteur Member State (co-RMS), France, received an application from Gowan Crop Protection Ltd for the renewal of approval of the active substance zoxamide. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (France), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.The RMS provided its initial evaluation of the dossier on zoxamide in the renewal assessment report (RAR), which was received by EFSA on 5 August 2016. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Gowan Crop Protection Ltd, for comments on 22 September 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 23 November 2016.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 zoxamide 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 zoxamide as a fungicide on wine and table grapes and potatoes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.The use of zoxamide according to the representative uses proposed at the European Union (EU) level (southern and northern zone) results in a sufficient fungicidal efficacy ag...

Review of the existing maximum residue levels for zoxamide according to Article 12 of Regulation (EC) No 396/2005 and setting of an import tolerance for onions, garlic and shallots

“…EFSA has based its assessment on the following documents: the PROFile submitted by the RMS; the evaluation report accompanying the PROFile (Latvia, 2023 ); the renewal assessment report (RAR) and its addenda prepared under Commission Regulation (EC) 1107/2009 (Latvia, 2016 , 2017 ); the conclusion on the peer review of the pesticide risk assessment of the active substance zoxamide (EFSA, 2017 ); the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2007 , 2009b ); the previous reasoned opinion on zoxamide (EFSA, 2016 ); the evaluation report submitted by the EMS in the framework of the MRL application (Latvia, 2019 ); the report on the pesticide peer review TC 100–zoxamide‐mammalian toxicity (EFSA, 2023b ). …”

“…the conclusion on the peer review of the pesticide risk assessment of the active substance zoxamide (EFSA, 2017 );…”

“…The toxicological profile of the active substance zoxamide and its metabolites was peer reviewed in 2017 and its outcome reported in an EFSA conclusion (EFSA, 2017 ); the toxicological reference values were implemented through Regulation (EU) 2018/692 12 and renewal report (European Commission, 2018 ). Additional toxicological information on metabolites was submitted to the EMS in support to the MRL application (Latvia, 2019 ).…”

“…In the framework of the peer review, the metabolism in primary crops was investigated after foliar spray application in fruits (grape, tomato, cucumber), pulses and oilseeds (pea) and root crops (potato) using zoxamide 14 C‐labelled in the phenyl ring (EFSA, 2017 ). In fruits, zoxamide was the main component of the total radioactive residue (TRR) in tomato (44%) and in both cucumber (98%) and grape (98%).…”

“…In 2016, EFSA initiated the peer review process for the renewal of the approval of zoxamide in accordance with Implementing Regulation (EU) No 844/2012. 7 The EFSA conclusion of the pesticide risk assessment of zoxamide has been adopted on 18 August 2017 (EFSA, 2017 ).…”