Conclusion on the peer review of the pesticide risk assessment of the active substance pyridate

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(8):3801 [84 pp.].
doi
10.2903/j.efsa.2014.3801
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00840
Approved
18 July 2014
Published
8 August 2014
Last Updated
11 March 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (871.9 KB)
Abstract

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 Austria, for the pesticide active substance pyridate are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of pyridate as a herbicide on sweet corn, cauliflower, broccoli and leek. 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.

Summary

Commission Regulation (EU) No 1141/2010, as amended by Commission Implementing Regulation (EU) No 380/2013, (hereinafter referred to as ’the Regulation’) lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances. Pyridate is one of the active substances listed in the Regulation. 

The RMS provided its initial evaluation of the dossier on pyridate in the Renewal Assessment Report (RAR), which was received by the EFSA on 11 June 2013. The peer review was initiated on 14 June 2013 by dispatching the RAR for consultation of the Member States and the applicant Belchim Crop Protection nv/sa. 

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of physical-chemical properties, mammalian toxicology, residues, environmental fate and behaviour, and ecotoxicology; and EFSA should adopt a conclusion on whether pyridate can be expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of pyridate as a herbicide on sweet corn, cauliflower, broccoli and leek, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

No data gaps or critical areas of concern have been identified in relation to the identity, physical and chemical properties of the active substance and analytical methods. A data gap was identified for the shelf life study of the current representative formulation.

No critical areas of concern have been identified in relation to mammalian toxicology. A data gap was identified to address the toxicological relevance of impurity 10.

No critical areas of concern have been identified in the section of residues. A data gap was identified to address the magnitude of residues in sweet corn grain in Northern Europe.

No data gaps or critical areas of concern have been identified in relation to the environmental exposure assessment. 

In the section on ecotoxicology a critical area of concern was indicated as a high long-term risk to mammals was identified for all representative uses. No-spray buffer zones up to 4 m and vegetated filter strips up to 20 m were necessary to conclude a low risk for aquatic organisms. No-spray buffer zones up to 5 m or drift reducing nozzles were necessary to conclude a low risk for non-target terrestrial plants. 

Keywords
pyridate, peer review, risk assessment, pesticide, herbicide, pyridafol
Print on demand
Number of Pages
84