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

No abstract available

Urea is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007.

Urea was included in Annex I to Directive 91/414/EEC on 1 September 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as ‘the Regulation’), and has subsequently been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report.

Greece being the designated rapporteur Member State submitted the DAR on urea in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 22 April 2008. The peer review was initiated on 31 July 2008 by dispatching the DAR for consultation of the notifiers the Forestry Commission and Phytophyl – N.G. Stavrakis. Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should deliver its conclusions on urea.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of urea as a fungicide treatment by spray and drenching to individual conifer tree stumps, as a spot spray attractant with an insecticide to olive trees, and as a mass trapping agent in liquid traps in olive groves, as proposed by the notifiers. 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 data gaps were identified for Annex II and III physchem data packages, a method of analysis for urea and the impurity biuret in the technical material. Also validated methods of analysis for urea in the formulations were identified as data gaps.

In the mammalian toxicology section the toxicological database is not suitable to set an AOEL and therefore the risk assessment for non-dietary exposure cannot be concluded.

No data gaps or critical areas of concern were identified in the residue section.

The information on the environmental fate and behaviour of urea in relation to the representative uses as a spray in olive trees and to conifer stumps was insufficient to complete the necessary environmental exposure assessment at the EU level. Data gaps were identified for satisfactory information on adsorption to soil of urea or its transformation products, for predicted environmental concentrations (PEC) in soil for urea, PEC in surface water/sediment for urea, ammonia, nitrate and nitrite, and PEC in groundwater for urea, nitrate and nitrite. No data gaps were identified for the representative uses by drench application of individual stumps by hand, or as a mass trapping agent in liquid traps. Based on the estimated atmospheric half-life performed by EFSA with US EPA AOPWIN program (v1.92), urea has a potential for long-range transport through the atmosphere.

A data gap was identified for studies on aquatic organisms to fulfil the Annex II data requirements. A data gap was also identified for the original studies summarised in the US EPA and OECD reports and the IUCLID database. Finally, a data gap was identified to address the risk to non-target organisms for the representative spray uses to conifer stumps and olive trees once the environmental exposure is finalised.

Urea, peer review, risk assessment, pesticide, fungicide, attractant