Flavouring Group Evaluation 25, (FGE.25): Aliphatic and aromatic hydrocarbons from chemical group 31 Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) 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 32 flavouring substances in the Flavouring Group Evaluation 25 (FGE.25), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 32 flavouring substances belong to chemical group 31, Annex I of the Commission Regulation (EC) No 1565/2000. The present Flavouring Group Evaluation deals with 32 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. Seventeen of the 32 flavouring substances possess chiral centres and 16 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 32 flavouring substances 27 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). Twenty-nine 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 32 flavouring substances in this group have intakes in Europe from 0.0012 to 2.7 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. Data on the genotoxicity of the flavouring substances in this group are limited and the genotoxicity could not be assessed adequately for these substances. For one candidate substance, 2-methylbuta1,3-diene (synonym: isoprene) [FL-no: 01.049], there is evidence of an in vivo genotoxic potential. Therefore, the Panel concluded that the Procedure could not be applied to this substance. The available data do not preclude evaluating the remaining 31 candidate substances using the Procedure. The available information on metabolism of the 31 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 18 of the flavouring substances the information is too limited and it cannot be assumed that they are metabolised to innocuous metabolites. For the remaining five 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 23 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 31 flavouring substances, evaluated using the Procedure, are 3300 microgram/person/day for one substance and 3700 microgram/person/day for each of the remaining 30 flavouring substances. These values are above the threshold 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 31 candidate substances in this flavouring group evaluation 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. 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 tests for the materials of commerce have been provided for 23 flavouring substances. 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 is missing. Thus, the final evaluation of the materials of commerce cannot be performed for eight substances [FL-no: 01.027, 01.032, 01.034, 01.035, 01.050, 01.055, 01.056 and 01.060], pending further information on isomerism. For 23 flavouring 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, 01.060, 01.064, 01.066 and 01.067] additional toxicity data are required. For six flavouring 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 the level of intake estimated on the basis of the MSDI approach. One flavouring substance, 2-methylbuta-1,3-diene [FL-no: 01.049], is genotoxic in vitro and in vivo and carcinogenic in experimental animals. Accordingly, the use as chemically defined flavouring substance is toxicologically not acceptable for this substance.