Carvone for uses as plant growth regulator (PGR) was included in Annex I to Directive 91/414/EEC on 1 August 2008 by Commission Directive 2008/44/EC, and has 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. As the active substance was approved before the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of the aforementioned regulation. The Netherlands, as the designated rapporteur Member State (RMS), prepared a supporting evaluation report and suggested carvone to be included in Annex IV of Regulation (EC) No 396/2005. This Annex lists the active substances that do not require the setting of MRLs.
This RMS compiled subsequently an application to include carvone in Annex IV of Regulation (EC) No 396/2005 in accordance with Article 6 of this Regulation. The Netherlands drafted an evaluation report in line with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 29 February 2012.
Apart from its use as a pesticide, consumer exposure to carvone may also result from other sources such as food flavouring, feed flavouring or, together with other active substances, in a zootechnical feed additive, personal care products and (veterinary) medicine. Furthermore, different ADI values for carvone had been established in the different food sector areas in the past. It was therefore necessary to involve the EFSA Scientific Committee, which adopted on 9 July 2014 a scientific opinion on the safety assessment of carvone, considering all sources of exposure, including pesticide authorisations and anticipated uses in the framework of Articles 10 and 12 of Regulation (EC) No 396/2005.
Nevertheless, in addition to the scientific opinion of the EFSA Scientific Committee, it was still considered necessary to address the criteria as defined by the European Commission for inclusion of a pesticide active substance in Annex IV of Regulation (EC) No 396/2005. Hence, based on the assessment of the Scientific Committee, EFSA prepared in December 2015 a draft statement, which addresses these criteria and which was circulated to Member States for consultation via written procedure. Comments received by 26 January 2016 were considered during the finalisation of this reasoned opinion. A Member State consultation report (EFSA, 2016) was developed, which is considered as background document to this reasoned opinion and, thus, is made publicly available. The following conclusions are derived.
While carvone is proposed for classification as a skin sensitizer 1 (H37), it is not reported to have carcinogenic, mutagenic or reprotoxic properties. This substance would therefore be eligible for inclusion in Annex IV to Regulation (EC) No 396/2005.
According to Commission Directive 2008/44/EC, the pesticide active substance carvone is defined with a d/l ratio of at least 100:1 and the aggregated oral exposure assessment for d-carvone, considering all sources of exposure (including the pesticide use), did not result in an exceedance of the ADI of 0.6 mg/kg bw per day.
The exposure resulting from the pesticide use of d-carvone was generally found to be lower than the natural exposure to d-carvone, except for toddlers where the pesticide exposure was found to be in the same range as the natural exposure. Furthermore, the exposure resulting from the pesticide use of d-carvone was found to be significantly lower that the exposure resulting from the other food chain related sources. Hence, it seems that criterion four for the inclusion of an active substance in Annex IV is fulfilled and inclusion of d-carvone in Annex IV of Regulation (EC) No 396/2005 seems to be appropriate.
It is noted that the toxicity of l-carvone remains unknown and it is not clear whether exposures of d-carvone and l-carvone may need to be combined in the future. Although the pesticide active substance d-carvone may contain up to 1% of l-carvone, this is expected to have a minor impact on the aggregated exposure to l-carvone.
It is also noted that l-carvone is the main constituent of another pesticide active substance called spearmint oil. However, this substance is not within the scope of this statement.