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

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(6):3736 [92 pp.].
doi
10.2903/j.efsa.2014.3736
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00758
Approved
4 June 2014
Published
12 June 2014
Last Updated
26 August 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 the Czech Republic, for the pesticide active substance flumioxazin 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 flumioxazin as a herbicide on winter wheat and sunflower (pre- and post-emergence). 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 in Annex I to Council Directive 91/414/EEC and establishes the list of those substances. Flumioxazin is one of the active substances listed in the Regulation.

The RMS provided its initial evaluation of the dossier on flumioxazin in the Renewal Assessment Report (RAR), which was received by the EFSA on 4 March 2013. The peer review was initiated on 18 March 2013 by dispatching the RAR for consultation of the Member States and the applicant Sumitomo Chemical Agro Europe S.A.S.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues and ecotoxicology, and that EFSA should adopt a conclusion on whether flumioxazin 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 flumioxazin as a herbicide on winter wheat, sunflower (pre-emergence) and sunflower (post-emergence), as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

In the area of identity, physical/chemical/technical properties and methods of analysis a data gap was identified for a method of analysis for a metabolite in surface water and for ILV for the QuEChERS method acidic matrix.

In the area of mammalian toxicology several data gaps, issues that could not be finalised and critical area of concerns were identified. Insufficient information was available to address whether the toxicity studies were representative of the proposed technical specification for the active substance and associated impurities, leading to a critical area of concern. Insufficient information was available to assess the toxicological relevance of impurities. The potential endocrine disruption of flumioxazin was identified as an issue that could not be finalised and a critical area of concern. Flumioxazin is classified as reproductive toxicity category 1B, leading to a critical area of concern.

With respect to residues and consumer safety, no critical areas of concern were identified. However, data gaps were identified for residue trials in sunflower in SEU, and for addressing the potential for residues in rotatioal crops.

No critical areas of concern were identified with respect to the environmental exposure to residues of flumioxazin or its metabolites with the available information. However, a data gap has been identified for reliable adsorption data of flumioxazin in at least an additional soil to complete the data set and overcome the limitations of the available study. Therefore, the ground water exposure assessment is not finalised.

Some data gaps were identified with respect to ecotoxicology and the potential endocrine disruption of flumioxazin was identified as an issue that could not be finalised.

Keywords
flumioxazin, peer review, risk assessment, pesticide, herbicide
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Number of Pages
92