The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food is asked to advise 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 Scientific Panel is asked to evaluate 35 flavouring substances in the Flavouring Group Evaluation FGE.20, using the procedure as referred to in the Commission Regulation EC No 1565/2000. These 35 flavouring substances belong to chemical group 23, Annex I of the Commission Regulation EC No 1565/2000. The present Flavouring Group Evaluation deals with 35 benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters. Three of the 35 flavouring substances possess a chiral centre. In each of these cases, the substance has been presented without any indication that the commercial flavouring substance has dominance of one or the other enantiomer. Three of the 35 substances can exist as geometrical isomers and in one of these cases, no indication has been given that one of the possible isomers has preponderance in the commercial flavouring material. Thirty-three of the flavouring substances are classified into structural class I, one is classified into structural class II and one is classified into structural class III. Eighteen 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 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 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 35 flavouring substances in this group have intakes in Europe from 0.001 to 10 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day), structural class II (540 microgram/person/day) and structural class III (90 microgram/person/day) substances. For the substances in this group the available data do not give rise to safety concern with respect to genotoxicity and carcinogenicity. Based on experimental evidence and general knowledge of toxicokinetics of structurally related compounds it is expected that the flavouring substances in this group would be rapidly and efficiently absorbed and 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 35 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 1300 to 3700 microgram/person/day for the 33 flavouring substances from structural class I. Thus, the intakes were all above the threshold of concern for structural class I of 1800 microgram/person/day, except for five flavouring substances [FL-no: 05.129, 05.142, 05.153, 05.158, and 08.080]. The estimated intakes of the one flavouring substance [FL-no: 05.066] assigned to structural class II and of the one [FL-no: 02.205] assigned to structural class III, based on the mTAMDI are 1600 and 3700 microgram/person/day, respectively, which are above the threshold of concern for structural class II of 540 microgram/person/day and for structural class III of 90 microgram/person/day. 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 for 30 of the 35 flavouring substances considered in this opinion the intakes, estimated on the basis of the mTAMDI, exceed the relevant threshold for their structural class, to which the flavouring substance has been assigned. Therefore, for these 30 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 tests for the materials of commerce have been provided for the 35 flavouring substances, except that information on stereoisomerism is missing for four of the substances. Thus, the final evaluation of the materials of commerce cannot be performed for four substances [FL-no: 09.313, 09.317, 09.570 and 09.852], pending further information.
