Citronella oil is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004,(3) as amended by Commission Regulation (EC) No 1095/2007.(4) Citronella oil 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,(5) in accordance with Commission Implementing Regulation (EU) No 540/2011,(6) as amended by Commission Implementing Regulation (EU) No 541/2011.(7) In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010,(8) 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. The 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. The United Kingdom being the designated rapporteur Member State submitted the DAR on citronella oil in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 7 January 2008. The peer review was initiated on 11 July 2008 by dispatching the DAR to the notifier Barrier Biotech Ltd, and on 24 February 2011 to the Member States, for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the area of mammalian toxicology and deliver its conclusions on citronella oil. The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of citronella oil as a herbicide applied by spot spray treatment on common ragwort growing on grassland, green cover, amenity grassland and land temporarily removed from production, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. Data gaps were identified for the section on identity, physical and chemical properties and analytical methods. An operator and worker risk assessment could not be performed for the representative use because the toxicological database was considered incomplete and not sufficient to identify the hazard of the active substance, and reliable exposure data for workers were not available. A data gap was set in the residue section to determine an appropriate withholding period before livestock can be allowed to re-enter the treated areas, in order to minimize the exposure of livestock and taking into account that treated ragwort may become more palatable when dying off. In addition, pending on the outcome of the outstanding data gap identified in the fate section on the potential groundwater contamination assessment, a consumer risk assessment through drinking water may be required. No information is available on the fate and behaviour in the environment of the known active components of citronella oil and its relevant impurities. A number of data gaps have been identified, including a potential groundwater contamination assessment. The proposed residue definition for environmental risk assessment should be considered as tentative only. The ecotoxicological risk assessment cannot be concluded. A data gap was identified to provide acute toxicity studies on aquatic organisms. Additionally, the risk to birds and mammals, aquatic organisms, bees, non-target arthropods, earthworms, soil macro-and micro-organisms, and terrestrial non-target plants should be further considered, due to the fact that information on fate and behaviour in the environment is missing. Chronic studies on aquatic organisms might be necessary and should be considered when information on fate and behaviour is available. The risk to biological methods of sewage treatment was considered to be low.
