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

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(9):3815 [94 pp.].
doi
10.2903/j.efsa.2014.3815
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00898
Approved
18 August 2014
Published
2 September 2014
Last Updated
11 March 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 France and the co-rapporteur Member State Slovakia for the pesticide active substance prosulfuron 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 prosulfuron as a herbicide on maize and sweet corn. 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. Prosulfuron is one of the active substances listed in the Regulation. 

The RMS and the Co-RMS provided their initial evaluation of the dossier on prosulfuron in the Renewal Assessment Report (RAR), which was received by the EFSA on 15 July 2013. The peer review was initiated on 18 July 2013 by dispatching the RAR for consultation of the Member States and the applicant Syngenta Crop Protection AG.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether prosulfuron 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 prosulfuron as a herbicide on maize and sweet corn, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

In the section on identity, physical/chemical/technical properties and methods of analysis a data gap was identified for the melting point and the temperature of decomposition.

In the section on mammalian toxicology a data gap was identified for a relevance assessment for the groundwater metabolites CGA300406 and CGS325025.

In the section on residues and consumer exposure no data gaps or concerns are raised and the risk assessment is finalised.

The data available for the section on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses, with the notable exception that the groundwater exposure assessment for soil metabolites M17 (unidentified) and M18 are not available. A critical area of concern was identified for the potential ground water exposure above the parametric drinking water limit (0.1 µg/L) by the parent prosulfuron in all or the majority of the EU groundwater scenarios, even when use is limited to one application every third year. Under alkaline soil conditions the limit of 0.1 µg/l is expected to be exceeded by metabolites CGA150829 (annual application: 6 out of 8 scenarios; triennial application: none), CGA300406 (annual application: 6 out of 8 scenarios; triennial application: none), CGA349707 (annual applications: all 8 scenarios, max. 0.958 µg/l; triennial application: all 8 scenarios, max. 0.356 µg/l) and CGA325025 (annual application: 1 out of 8 scenarios; triennial application: none). Under acidic soil conditions the limit of 0.1 µg/l is expected to be exceeded by metabolites CGA150829 (annual application: 6 out of 8 scenarios; triennial application: none) and CGA349707 (annual applications: all 8 scenarios, max. 0.908 µg/l; triennial application: all 8 scenarios, max. 0.331 µg/l). On the basis of the available data on the biological / pesticidal activity, the assessment of non relevance could not be finalised for any of these metabolites. The mammalian toxicology non relevance assessment could not be finalised for metabolites CGA 300406 and CGS 325025. This leads to issues that could not be finalised for all of the representative uses.

In the section on ecotoxicology a data gap and a critical area of concern has been identified for aquatic organisms in situations which are represented by the D4 and D5 FOCUS surface water scenarios for all the representative uses.

Keywords
prosulfuron, peer review, risk assessment, pesticide, herbicide
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Number of Pages
94