Clove oil is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/20043, as amended by Commission Regulation (EC) No 1095/20074. Clove 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 1107/20095, in accordance with Commission Implementing Regulation (EU) No 540/20116, as amended by Commission Implementing Regulation (EU) No 541/20117. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/20108, 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. The United Kingdom being the designated rapporteur Member State submitted the DAR on clove 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 Xeda International SA and on 24 February 2011 to the Member States for consultation. 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 clove oil. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of clove oil as a fungicide and bactericide by post-harvest indoor applications as a drench on apples, pears and peaches, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. Data gaps were identified in the section for physical and chemical properties and analytical methods. In the section mammalian toxicology, two data gaps were identified: the first one for an acute inhalation study with eugenol, the second one for an assessment of the toxicological profile of clove oil covering a representative technical specification. In this context two critical areas of concern were indicated: it could not be demonstrated that the material tested in the toxicological studies is representative of the technical specification and no reference values could be derived for clove oil. Consequently, a risk assessment for operators and workers could not be performed. The consumer risk assessment could not be conducted based on the information available and the lack of toxicological reference values for clove oil. Studies on the fate and behaviour of clove oil and/ or its active component eugenol in the environment are not available. A waiver for the environmental data and risk assessment has been proposed by the notifier on basis of the representative uses. It was concluded during the peer review that the waiver is appropriate if the product is used in a closed installation and the treatment solutions are treated as waste residues. A data gap was identified in the ecotoxicology section to address the risk from clove oil to the organisms involved in the biological methods for sewage treatment plants.
