Flavouring Group Evaluation 25, Revision 1 (FGE.25Rev1): Aliphatic and aromatic hydrocarbons from chemical group 31 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 34 flavouring substances in the Flavouring Group Evaluation 25, Revision 2 (FGE.25Rev1), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 34 flavouring substances belong to chemical group 31, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with 34 aliphatic and aromatic hydrocarbons which have been divided into eight subgroups: I) acyclic alkanes, II) acyclic alkenes, III) cyclohexene hydrocarbons, IVa) benzene hydrocarbons, IVb) napthalene hydrocarbons, IVc) diphenylmethane, V) bi-and tricyclic, non-aromatic hydrocarbons and VI) macrocyclic, non-aromatic hydrocarbons. Eighteen of the 34 flavouring substances possess chiral centres and 17 can exist as geometrical isomers due to presence and position of double bonds. For eight of these flavouring substances the stereoisomeric composition has not been specified. Of the 34 flavouring substances 29 are classified into structural class I, two into structural class II, and three into structural class III according to the decision tree approach presented by Cramer et al. (1978). Thirty-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 the 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 34 flavouring substances in this group have intakes in Europe from 0.0012 to 14 microgram/capita/day, which are all below the threshold of concern for structural class I, II and III of 1800, 540 and 90 microgram/person/day, respectively. Data on the genotoxicity of the flavouring substances in this group are limited and the genotoxicity could not be assessed adequately for these substances. However, the Panel concluded that the available data do not preclude an evaluation of the 34 flavouring substances using the Procedure. The available information on metabolism of the 34 flavouring substances evaluated through the Procedure or on structurally related substances for this FGE was very limited. Overall, only for eight of the flavouring substances it can be concluded that they will be metabolised into innocuous metabolites. For 20 of the flavouring substances the information is too limited and it cannot be assumed that they are metabolised to innocuous metabolites. For the remaining six of the flavouring substances there are data, which show that they may be metabolised to toxic metabolites. 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 is concluded that the eight flavouring substances which are expected to be metabolised to innocuous substances would not give rise to safety concerns at their estimated intakes arising from their use as flavouring substances based on the MSDI approach. For the remaining 26 flavouring substances, which cannot be anticipated to be metabolised to innocuous products, or for structurally related substances, no adequate No Observed Adverse Effect Level (NOAEL) were available. Therefore, additional toxicological data are required. The mTAMDI values for the 32 flavouring substances, for which use levels have been provided, are in the range of 3100 to 3900 microgram/person/day. These values are above the threshold of concern for structural class I, II and III of 1800, 540 and 90 microgram/person/day, respectively. Accordingly, intake estimates according to the mTAMDI for the 32 candidate substances, for which use levels have been provided, exceed the thresholds of concern for the three structural classes and more reliable exposure data are requested. On the basis of such additional data, the flavouring substances should be considered using the Procedure. Subsequently, additional data might become necessary. For the two remaining candidate substances [FL-no: 01.070 and 01.078] use levels are required. In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications. Specifications including complete purity criteria and identity for the materials of commerce have been provided for 25 flavouring substances. For one substance [FL-no: 01.078] an identity test and minimum assay value are missing. For eight substances [FL-no: 01.027, 01.032, 01.034, 01.035, 01.050, 01.055, 01.056 and 01.060] information on stereoisomerism has not been specified. Thus, the final evaluation of the materials of commerce cannot be performed for nine substances [FLno: 01.027, 01.032, 01.034, 01.035, 01.050, 01.055, 01.056, 01.060 and 01.078] pending further information on isomerism and/or specifications. For 26 candidate substances [FL-no: 01.022, 01.023, 01.030, 01.031, 01.032, 01.035, 01.036, 01.037, 01.042, 01.043, 01.044, 01.047, 01.050, 01.051, 01.052, 01.053, 01.055, 01.056, 01.058, 01.059, 01.060, 01.064, 01.066, 01.067, 01.070 and 10.078] additional toxicity data are required. For six candidate substances [FL-no: 01.028, 01.033, 01.038, 01.039, 01.054 and 01.057] the Panel concluded that they would present no safety concern at their estimated levels of intake based on the MSDI approach.