Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species-and compound-specific and can be used to predict (sub)lethal effects of pesticides under untested (time-variable) exposure conditions. Three different types of TKTD models are described, viz., (i) the 'General Unified Threshold models of Survival' (GUTS), (ii) those based on the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All these TKTD models follow the principle that the processes influencing internal exposure of an organism, (TK), are separated from the processes that lead to damage and effects/mortality (TD). GUTS models can be used to predict survival rate under untested exposure conditions. DEBtox models explore the effects on growth and reproduction of toxicants over time, even over the entire life cycle. TKTD model for primary producers and pesticides have been developed for algae, Lemna and Myriophyllum. For all TKTD model calibration, both toxicity data on standard test species and/or additional species can be used. For validation, substance and species-specific data sets from independent refined-exposure experiments are required. Based on the current state of the art (e.g. lack of documented and evaluated examples), the DEBtox modelling approach is currently limited to research applications. However, its great potential for future use in prospective ERA for pesticides is recognised. The GUTS model and the Lemna model are considered ready to be used in risk assessment. 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. As a third deliverable of this mandate, the PPR Panel is asked to develop a Scientific Opinion describing the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models for aquatic organisms and prospective environmental risk assessment (ERA) for pesticides with the main focus on: (i) regulatory questions that can be addressed by TKTD modelling, (ii) available TKTD models for aquatic organisms, (iii) model parameters that need to be included and checked in evaluating the acceptability of regulatory relevant TKTD models, and (iv) selection of the species to be modelled.Chapter 2 presents the underlying concepts, terminology, application domains and complexity levels of three different classes of TKTD models intended to be used in risk assessment, viz., (i) the 'General Unified Threshold models of Survival' (GUTS), (ii) toxicity models derived from the Dynamic Energy Budget theory (DEBtox models), and (iii) models for primary producers. All ...

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Germany, for the pesticide active substance copper compounds 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 copper compounds as a fungicide on grapes, tomatoes and cucurbits. 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.

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 ...

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Sweden, and co-rapporteur Member State, Finland, for the pesticide active substance thiophanate-methyl 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 thiophanate-methyl as a fungicide on wine grapes, tomato, aubergine, leek, fresh beans with pods and wheat (winter and durum). The reliable endpoints, 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), Sweden, and co-rapporteur Member State (co-RMS), Finland, received an application from Nisso Chemical Europe GmbH for the renewal of approval of the active substance thiophanate-methyl. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co-RMS (Finland), the European Commission and the European Food Safety Authority (EFSA) about the admissibility.The RMS provided its initial evaluation of the dossier on thiophanate-methyl in the renewal assessment report (RAR), which was received by EFSA on 1 November 2016. In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Nisso Chemical Europe GmbH, for comments on 28 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 30 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 experts' consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology.In accordance with Article 13(1) of the Regulation, EFSA should adopt a conclusion on whether thiophanate-methyl 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 thiophanate-methyl as a fungicide on wine grapes, tomato, aubergine, leek, fresh beans with pods and wheat (winter and durum), as proposed by the applicant. Full details of the representative uses can b...

The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co-rapporteur Member State, Spain, for the pesticide active substance indoxacarb 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 indoxacarb as an insecticide on maize, sweet corn and lettuce. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.