The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the flavouring substance spilanthol in Flavouring Group Evaluation 303, Revision 1, using the Procedure according to Commission Regulation (EC) No 1565/2000. This revision is made as new 90 days toxicity data have been submitted for spilanthol ]. The substance was considered not to have genotoxic potential. The substance was evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that spilanthol .121] does not give rise to safety concern at its level of dietary intake, estimated on the basis of the Maximum Surveyderived Daily Intake (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the candidate substance. According to the Flavour Industry spilanthol has been identified in the plant Spilanthes oleracea, which is used in some countries as a spice.
© EuropeanIn its evaluation, the Panel as a default used the 'Maximised Survey-derived Daily Intake' (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavouring Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a 'modified Theoretical Added Maximum Daily Intake' (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.No in vitro or in vivo data on genotoxicity are available for the candidate substance spilanthol. However, for the two structurally related substances deca-(2E, 4E)-dienoic acid isobutyl-amide [FLno: 16.091] and N-cyclopropyl (2E,6Z)-nonadienamide ] negative genotoxicity studies are available. The Panel therefore concluded that the lack of genotoxi...