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 four flavouring substances in the Flavouring Group Evaluation FGE. 12, using the procedure as referred to in the Commission Regulation EC No 1565/2000. These four flavouring substances belong to chemical group 7, Annex I of the Commission Regulation EC No 1565/2000. The present Flavouring Group Evaluation deals with two primary alicyclic esters, one alcohol, and one aldehyde. All four flavouring substances possess one or more chiral centres. In each of these cases, the substances have been presented without any indication that the commercial flavouring substance has dominance of one or the other enantiomer. The four flavouring candidate substances are classified into structural class I. Two of the flavouring substances in the present group have been reported to occur in essential oils. 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 four flavouring substances in this group have intakes in Europe from 0.01 to 0.6 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day) substances. The flavouring substances are expected to be metabolised to innocuous products at the estimated levels of use as flavouring substances. The genotoxic potential of this group of flavouring substances cannot be assessed since information on the candidate and supporting substances is missing, but neither the chemical structures of the candidate substances in this group nor the metabolic data available suggest that reactive metabolites could be generated. It is considered that on the basis of the default MSDI approach these four flavouring 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 1600 to 3700 microgram/person/day for the four 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 one flavouring substance [ FL-no: 05.183]. This substance is also expected to be metabolised to innocuous products. Thus for three of the four 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: 02.186, 09.342, and 09.670] 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, 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 four flavouring substances, except that information on stereoisomerism is missing for all the substances. Thus, the final evaluation of the materials of commerce cannot be performed for the substances, pending further information.
