Conclusion on the peer review of the pesticide risk assessment of the active substance 1,4-diaminobutane (putrescine)
No abstract available
1,4-Diaminobutane (putrescine) 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.
1,4-Diaminobutane 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.
Austria being the designated rapporteur Member State submitted the DAR on 1,4-diaminobutane in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 28 November 2007. The peer review was initiated on 25 June 2008 by dispatching the DAR to the notifier Suterra LLC, and on 16 December 2010 to the Member States, for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and that the EFSA should deliver its conclusions on 1,4-diaminobutane.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of 1,4-diaminobutane as an insect attractant in orchards (fruit crops), citrus and other crops where Ceratitis capitata (Mediterranean fruit fly) causes damage, as proposed by the notifier at the time of submission. Full details of the representative uses can be found in Appendix A to this report.
Data gaps were identified in the section on identity, physical and chemical properties and analytical methods.
No data gaps or critical areas of concern were identified in the mammalian toxicology section.
No data gaps or critical areas of concern were identified in the residue section.
Data gaps were identified for satisfactory information on the ready biodegradability of 1,4-diaminobutane and information on its hydrolytic stability under sterile conditions. Most importantly, there is a data gap for a comparison of the estimated quantity of 1,4-diaminobutane that may reach the different environmental compartments (primarily air but also soil, groundwater and surface water), consequent to the representative use assessed, compared to natural background levels. The environmental exposure assessment could not be finalised in the absence of this information.
Two data gaps were identified in the ecotoxicology section. Pending on the outcome of the fate and behaviour assessment, the risk of 1,4-diaminobutane to non-target species should be addressed. The mandatory toxicity studies with aquatic organisms should be submitted.
No critical areas of concern were identified.
1,4-diaminobutane, putrescine, peer review, risk assessment, insect attractant
