Scientific Opinion on Flavouring Group Evaluation 20, Revision 2 (FGE.20Rev2): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 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 41 flavouring substances in the Flavouring Group Evaluation 20, Revision 2 (FGE.20Rev2), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 41 flavouring substances belong to chemical group 23 and 30, Annex I of the Commission Regulation (EC) No 1565/2000. FGE.20Rev2 includes the assessment of 5 additional candidate substances compared to FGE.20Rev1. The present FGE.20Rev2 deals in total with 41 benzyl alcohols, benzaldehydes, related acetals, benzoic acids and related esters and a hydroxy- and alkoxy-substituted biphenyl derivative. Four of the 41 flavouring substances possess one or two chiral centres and three of the substances can exist as geometrical isomers. For two of these seven substances information about the stereoisomeric composition has not been specified. Thirty-seven of the flavouring substances are classified into structural class I, three are classified into structural class II and one is classified into structural class III according to the decision tree approach pesented by Cramer et al. (Cramer et al., 1978). Twenty-one 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 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 Flavour 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. According to the default MSDI approach, the 37 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The three substances in structural class II [FL-no: 05.066, 05.221 and 06.104] have estimated intakes of 1.2, 0.61 and 100 microgram/capita/day, respectively, and the one substance in structural class III[FL-no 02.205] has an estimated intake of 0.011 microgram/capita/day. These intakes are below the threshold values of 540 and 90 microgram/person/day for structural class II and III substances, respectively. For the substances in this group the available genotoxicity data do not preclude the evaluation of the candidate substances using the Procedure. It is anticipated that the flavouring substances in this group would be rapidly metabolised to innocuous products. It was noted that where toxicity data were available they were consistent with the conclusions in the present flavouring group evaluation using the Procedure. It was considered that on the basis of the default MSDI approach these 41 substances would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances. When the estimated intakes were based on the mTAMDI they ranged from 1400 to 120000 microgram/person/day for the 37 flavouring substances from structural class I. The intakes were all above the threshold of concern for structural class I of 1800 microgram/person/day, except for five substances [FL-no: 05.129, 05.142, 05.153, 05.158 and 08.080]. The estimated intakes, based on the mTAMDI, of the three substances [FL-no: 05.066, 05.221 and 06.104] assigned to structural class II and of the one [FL-no: 02.205] assigned to structural class III, were 1600, 7000, 3900 and 3900 microgram/person/day, respectively, which are above the threshold of concern for these classes (540 and 90 microgram/person/day for structural class II and III, respectively). The five substances [FL-no: 05.129, 05.142, 05.153, 05.158, and 08.080], which have mTAMDI intake estimates below the threshold of concern for structural class I, are also expected to be metabolised to innocuous products. Thus, on the basis of the mTAMDI, the estimated intakes for 36 of the 41 flavouring substances considered in this Opinion, exceed the relevant threshold for their structural class to which the flavouring substance has been assigned. Therefore, for these 36 substances more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered along the steps of the Procedure. Following this procedure additional toxicological data might become necessary. In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for the 41 flavouring substances. Information on stereoisomerism has not been specified for two of the substances [FL-no: 06.104 and 09.570]. Thus, the final evaluation of the materials of commerce cannot be performed for these two substances, pending further information. The remaining 39 candidate substances would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.