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Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonates
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance potassium phosphonates are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of potassium phosphonates as a fungicide on grapes. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
© European Food Safety Authority, 2012
Potassium phosphonates is a new active substance for which, in accordance with Article 6(2) of Council Directive 91/414/EEC, France (hereinafter referred to as the ‘RMS’) received an application from Luxembourg Industries (Pamol) Ltd for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2003/636/EC.
The RMS provided its initial evaluation of the dossier on potassium phosphonates in the Draft Assessment Report (DAR), which was received by the EFSA on 1 February 2005. The peer review was initiated on 15 February 2005 by dispatching the DAR for consultation of the Member States and the applicant Luxembourg Industries (Pamol) Ltd. In accordance with Commission Regulation (EU) No 188/2011 Article 11(6) additional information was requested. The RMS’s evaluation of the additional information was submitted to the EFSA in the format of Addenda to the DAR. The Addenda were dispatched for consultation of the Member States and the applicant Luxembourg Industries (Pamol) Ltd on 5 October 2011.
Following consideration of the comments received on the DAR and Addenda, it was concluded that EFSA should conduct an expert consultation and should adopt a conclusion on whether potassium phosphonates can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of potassium phosphonates as a fungicide on grapes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
Data gaps were identified in the section on physical and chemical properties and analytical methods.
No data gaps or areas of concern were identified in the area of mammalian toxicology and the risk assessment was finalised.
No data gaps were identified in the area of residues and the risk assessment can be finalised.
The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses assessed. However some data are lacking on the rate of microbially mediated oxidation of phosphonic acid salts to phosphate in soil. A data gap is identified for information to be provided on two more agricultural soils. Also the assessment of the exposure of natural surface water by phosphate ions that may result as a consequence of the use of potassium phosphonates is not finalised in the context of managing /avoiding eutrophication of surface waters.
A high long-term risk to insectivorous birds was indicated on the basis of the available data.
Potassium phosphonates, potassium hydrogen phosphonate, dipotassium phosphonate, peer review, risk assessment, pesticide, fungicide