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

more »

... proach 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 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. SUMMARY The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to re-evaluate the flavouring substance in the Flavouring Group Evaluation 303Rev1, using the Procedure as referred to in the Commission Regulation ( EC) No 1565/2000. The flavouring substance belongs to chemical group 30, Annex I of the Commission Regulation (EC) No 1565/2000. The present revision of FGE.303, FGE.303Rev1 includes a re-evaluation of spilanthol as additional data, from a 90-day dietary rat study have become available. The candidate substance spilanthol .121] is a branched chain unsaturated aliphatic amide. The specifications provided specify the stereoisomeric composition. Spilanthol is assigned to structural class III, according to the decision tree approach presented by Cramer et al., 1978. According to the Flavour Industry spilanthol has been identified in the plant Spilanthes oleracea, which is used in some countries as a spice. In 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 genotoxicity data for the candidate substance spilanthol .121] does not preclude the evaluation of this aliphatic amide using the Procedure. The candidate substance cannot be anticipated to be metabolised to innocuous products. According to the default MSDI approach, spilanthol has an intake in Europe of 24 µg/capita/day, which is below the threshold of concern value for structural class III substances of 90 µg/person/day. When the estimated intake was based on the mTAMDI approach it is 670 µg/person/day for the candidate substance, which is above the threshold of concern for a structural III substance of 90 µg/person/day. Therefore more reliable exposure data are required. On the basis of such additional data, the flavouring substance should be reconsidered using the Procedure. Subsequently, additional data might become necessary.