The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 63 flavouring substances in the Flavouring Group Evaluation 10, including additional two substances in this Revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. For one substance .170] a concern for genotoxicity could not be ruled out. The remaining 62 substances were evaluated through a stepwise approach (the Procedure) 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 the 62 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For four substances evaluated through the Procedure, the stereoisomeric composition has not been specified sufficiently. The flavouring substances are alcohols, aldehydes, acetals, carboxylic acids and esters containing additional oxygenated functional groups and lactones.
© European FoodThirty-six of the candidate substances possess one or more chiral centres and eight can exist as geometrical isomers due to the presence and the position of a double bond. For five of these substances 10.040, 10.059, 10.063 and 10.170] the stereoisomeric composition / composition of mixture has not been specified sufficiently.Fifty-five candidate substances belong to structural class I, six belong to structural class II, and two belong to structural class III according to the decision tree approach presented by Cramer et al. (1978).Fifty of the flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intakes" (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 th...