Scientific Opinion on Flavouring Group Evaluation 303, Revision 1 (FGE.303Rev1): Spilanthol from chemical group 30
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 [FL-no: 16.121] 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 [FL-no: 16.121]. 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 [FL-no: 16.121] 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.