Scientific Opinion on Flavouring Group Evaluation 303 (FGE.303): Spilanthol from chemical group 30 EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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 evaluate one flavouring substance in the Flavouring Group Evaluation 303, 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 candidate substance spilanthol [FL-no: 16.121] is a branched chain unsaturated aliphatic amide from chemical group 30. The substance has been presented with specification of the stereoisomeric composition. The candidate substance was 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. Genotoxicity data are not available for the candidate substance spilanthol [FL-no: 16.121]. However, the Panel considers that the lack of genotoxicity data do not preclude the evaluation of this aliphatic amide by using the Procedure. The candidate substance cannot be anticipated to be metabolised to innocuous products. According to the default MSDI approach, the candidate substance in this group has an intake in Europe of 24 micrograms/capita/day [FL-no: 16.121]. For the candidate substance, this is below the threshold of concern value for structural class III (90 micrograms/person/day). When the estimated intake was based on the mTAMDI approach it is 830 micrograms/person/day for the candidate substance from structural class III, which is above the threshold of concern for structural III of 90 micrograms/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. No relevant data on toxicity are available for the candidate substance or the three supporting substances. The only toxicity data available is a 28-day study which is not considered sufficient to evaluate chronic effects of the substance. Accordingly, additional data are required for the candidate substance. According to the practice of the Panel, a minimum requirement to provide an adequate NOAEL for flavourings in the Procedure is a 90-day study. In order to determine whether the conclusion for the candidate substance can be applied to the material of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity for the material of commerce have been provided for the flavouring substance. In conclusion, for the candidate substance spilanthol [FL-no: 16.121] additional data on chemical defined material are required as a 28 day study is not considered sufficient to deriving a NOAEL.