Conclusion on the peer review of the pesticide risk assessment of the active substance methyl nonyl ketone
No abstract available
Methyl nonyl ketone 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.
Methyl nonyl ketone 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 540/20116, 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.
Belgium being the designated rapporteur Member State submitted the DAR on methyl nonyl ketone in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 18 September 2006. The peer review was initiated on 12 June 2008 by dispatching the DAR for consultation of the original notifier Pet and Gardening Manufacturing Ltd (the notifier is now Spotless Punch Ltd). 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 methyl nonyl ketone.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of methyl nonyl ketone as an animal repellent for the protection of home garden and amenity grass, ornamentals and vegetable patches, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.
Numerous data gaps have been identified for the physical and chemical properties of the active substance and the formulation. The technical specification for this compound is open because the 5- batch analysis was not conducted according to GLP. Data gaps for methods for the technical material, formulation, soil, water and air have been identified.
A critical area of concern was identified for methyl nonyl ketone in the mammalian toxicology section, as it was not possible to assess the compliance of the batches tested with the proposed specification (both missing). Based on the outcome of the vapour pressure study (data gap identified by physical chemical properties section), an acute inhalation toxicity study might be required. No significant residues in plant or animal matrices were expected based on the representative use, and a quantitative consumer risk assessment is therefore not required.
The information on the environmental fate and behaviour of methyl nonyl ketone in relation to the representative uses assessed was insufficient to complete the necessary environmental exposure assessment at the EU level. The fate and behaviour in soil and natural sediment water systems has not been addressed. Consequently the environmental exposure assessment for soil, surface water and groundwater for any transformation products that might be formed from methyl nonyl ketone could not be finalised. A data gap was also identified for the adsorption/desorption properties of the active substance, and therefore the available predicted environmental concentrations in surface water can not be considered valid. Because of the lack of relevant end points for methyl nonyl ketone the groundwater exposure assessment could not be finalised.
A critical area of concern was identified for methyl nonyl ketone in the ecotoxicology section, as it was not possible to assess the compliance of the batches tested with the proposed specification (both missing). A data gap was identified to provide acute toxicity studies for fish to fulfil the Annex II data requirements. Data gaps were also identified for a new risk assessment for aquatic organisms, and to further address the risk to soil-living organisms (i.e. earthworms, other soil macro- and microorganisms, soil non-target arthropods).
Methyl nonyl ketone, peer review, risk assessment, pesticide, repellent
