The 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 Panel is asked to evaluate six flavouring substances in the Flavouring Group Evaluation FGE. 11, using the procedure as referred to in the Commission Regulation EC No 1565/2000. These six flavouring substances belong to chemical group 10, Annex I of the Commission Regulation EC No 1565/2000. The present Flavouring Group Evaluation deals with six flavouring substances, alpha-and beta-diketones, one related ketal, hydroxyketones, and diols. One of the six flavouring substances possesses two chiral centres [FL-no: 02.133] and another substance possess one chiral centre [FL-no: 07.167]. Three of the flavouring substances are classified into structural class I, and three are classified into structural class II. All flavouring substances in this 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 (MSDIs) 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 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 six flavouring substances in this group have intakes in Europe from 0.0012 to 3.1 microgram/capita/day which are below the threshold of concern value for both structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances. It is anticipated that five of the six flavouring substances (alpha-diketones and a related ketal, hydroxyketones and diols) undergo efficient metabolic detoxification. One flavouring substance, pentan-2,4-dione [FL-no: 07.191], is genotoxic in vitro and in vivo. Accordingly, its use as chemically defined flavouring substance is toxicologically not acceptable. Among the substances in this flavouring group, only pentan-2,4-dione [FL-no: 07.191] exhibits the structural feature of a methylene group which is activated due to its position between two carbonyl groups. Concerning the five other flavouring substances, the number of genotoxicty studies which can be considered as valid is very limited, however, the data which are available for some structurally related substances do not give rise to safety concern with respect to genotoxicity. It was considered that on the basis of the default MSDI approach the five 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 1543 to 3724 microgram/person/day for the three flavouring substances from structural class I. Thus, the intake is above the threshold of concern for structural class I of 1800 microgram/person/day for one flavouring substance [FL-no: 02.133], and below for the two flavouring substances [FL-no: 07.071 and 07.152]. For each of the three other flavouring substances [FL-no: 07.165, 07.167, and 07.191] assigned to structural class II, the estimated intake based on the mTAMDI is 1543 microgram/person/day, which is above the threshold of concern for structural class II of 540 microgram/person/day. The two substances [FL-no: 07.071 and 07.152], 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 three of the five 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 three substances [FL-no: 02.133, 07.165, 07.167] 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 material of commerce for the flavouring substances, 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 all six flavouring substances.
