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Conclusion on the peer review of the pesticide risk assessment of the active substance plant oils/spearmint oil
No abstract available
Spearmint oil 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.
Spearmint oil was included in Annex I to Directive 91/414/EEC on 18 December 2008 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.
Sweden being the designated rapporteur Member State submitted the DAR on spearmint oil in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 9 November 2007. The peer review was initiated on 18 June 2008 by dispatching the DAR for consultation of the notifier (XEDA International). Subsequently the DAR was dispatched for consultation of the Member States on 24 February 2011. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the areas of mammalian toxicology and deliver its conclusions on spearmint oil.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of spearmint oil as a plant growth regulator on potatoes as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.
In the area of identity, physical/chemical/technical properties and methods of analysis a data gap was identified for an Annex II data package for the active components that make up spearmint oil. Data gaps for the formulation are auto-flammability, accelerated storage and shelf life. No methods of analysis were available for products of plant and animal origin and for soil, water and air.
In the mammalian toxicology area data gaps were identified for the definition of the toxicological profile of spearmint oil; the database was insufficient to set reference values and the risk assessment is inconclusive.
In the residues section it was concluded that significant levels of residues of (R)-carvone will occur in potatoes upon application of spearmint oil according to the proposed use scenario. However, several data gaps were identified and a final residue definition for risk assessment and monitoring could not be derived. Furthermore, in absence of agreed toxicological reference values a consumer risk assessment could not be performed.
The environmental fate and behaviour section of the dossier was empty. Consequently 4 data gaps have been identified. Quantitative structure activity relationship (QSAR) approaches have been used to obtain more uncertain than usual input parameters to carry out groundwater exposure modelling for the main constituent of spearmint oil. When the uncertainty in the use of the QSAR approach is included in the modelling strategy, these modelling results indicate a high potential for groundwater contamination by the pesticide active substance carvone, consequent to the representative use assessed, in the situation when treated potatoes are used as seed potatoes.
The data set for the ecotoxicological assessments was not sufficient, therefore the risk assessments for non-target organisms could not be finalised.
Spearmint oil, (R)-carvone, L-carvone, (5R)-2-methyl-5-(prop-1-ene-2-yl)cyclohex-2-en-1-one, peer review, risk assessment, pesticide, plant growth regulator