Limestone 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). Limestone 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. 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 limestone 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 Agro Radomysl a.s. and on 20 October 2010 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 limestone. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of limestone as a repellent for use in forestry, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. It should be emphasized that the substance notified as limestone is mainly composed of calcium carbonate. A data gaps was identified in the section on physical and chemical properties. No data gaps or critical areas of concern were identified in the mammalian toxicology section. No significant residues in plant or animal matrices are expected based on the representative uses. Therefore a consumer risk assessment was not required. Limestone is a naturally occurring sedimentary rock composed largely of the mineral calcite (calcium carbonate: CaCO3). Considering the nature of the substance and the limited usage leading to negligible levels of environmental exposure, a definition of residue in the environment for monitoring is deemed to be unnecessary for limestone (CaCO3). Due to negligible levels of environmental exposure arising from the representative uses, the risk can be considered low for non-target organisms. No data gaps or critical areas of concern were identified in the ecotoxicology section.
