Scientific Opinion on the safety assessment of carvone, considering all sources of exposure
Carvone occurs naturally as dextrorotatory (d-) and levorotatory (l-) enantiomers in several food items; these may also be used as a pesticide, food flavouring, feed flavouring, in feed additive, in personal care products and as (veterinary) medicine. In order to improve coherence regarding the risk assessment of carvone in the different food and feed sector areas, EFSA asked its Scientific Committee to establish a single ADI for carvone, estimate the overall exposure of European consumers, and quantify the contribution for each source of exposure to the overall exposure of carvone. Having reviewed the information available the Scientific Committee decided to address d-carvone and l-carvone separately and limit its assessment to the oral intake of d- and l-carvone. The Scientific Committee established an ADI of 0.6 mg/kg bw/day for d-carvone, based on the BMDL10 of 60 mg/kg bw/day for an increase in relative liver weight in the rat 90-day studies and an uncertainty factor of 100. The Scientific Committee could not establish an ADI for l-carvone because of a lack of toxicological data for this enantiomer. The highest level of aggregated exposure to d-carvone is estimated to be 0.60 mg/kg bw/day, i.e. is at the level of the ADI established for d-carvone. The highest level of aggregated exposure to l-carvone is three-fold that of d-carvone. In view of key uncertainties 1) on the toxicity of l-carvone, 2) on the biological relevance of the endpoint selected to establish the ADI for d-carvone and its use as a surrogate for the observed lethality in tested animals, 3) whether d- and l-carvone should be considered together for possible combined effects and 4) in the aggregated exposure assessments to d- and to l-carvone, the Scientific Committee recommended generating additional data to refine the current risk assessment.