Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Flavouring Group Evaluation 15 (FGE.15): Aryl-substituted saturated and unsaturated primary alcohol/aldehyde/acid/ester der

Abstract

The present Flavouring Group Evaluation deals with eight aryl-substituted saturated and unsaturated primary alcohol, aldehyde, carboxylic acid and ester derivatives.Due to the presence and the position of double bonds, three of the eight flavouring substances can exist as geometrical isomers. In each of these cases, no indication of the preponderance of either of the possible isomers in the commercial flavouring material has been given.The eight flavouring substances are classified into structural class I.Five of the eight flavouring substances in the present group have been reported to occur naturally in a wide range of food items.In its evaluation, the Scientific Panel as a default used the Maximised Survey-derived Daily Intakes (MSDIs) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Scientific 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 Scientific 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 Scientific Panel to make a more realistic estimate of the intakes of the flavouring substances, the Scientific 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 Scientific Panel decided not to carry out a formal Flavouring Evaluation Group 15Aryl-substituted saturated and unsaturated primary alcohol/aldehyde/acid/ester derivatives from chemical group 22The EFSA Journal (2005) 247 2 safety assessment using the Procedure. In these cases the Scientific Panel requires more precise data on use and use levels.According to the default MSDI approach, the eight flavouring substances in this group have intakes in Europe from 0.012 to 0.37 microgram/capita/day which are below the threshold of concern value for structural class I (1800 microgram/person/day) substances.All eight candidate substances in this flavouring group may be expected to be metabolised to innocuous products.The available genotoxicity data are not sufficient to evaluate the genotoxicity adequately, however, the data available on mutagenic and clastogenic activity of both candidate and supporting substances as well as the chemical structures of the candidate substances do not give reason for concern with respect to genotoxicity of the eight candidate substances in this flavouring group evaluation.It is noted that ...