Scientific Opinion on Flavouring Group Evaluation 25, Revision 2 (FGE.25Rev2): Aliphatic and aromatic hydrocarbons from chemical group 31

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 37 flavouring substances in the Flavouring Group Evaluation 25, Revision 2, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the ten substances 01.027, 01.028, 01.033, 01.034, 01.038, 01.039, 01.046, 01.054 and 01.057] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining 27 candidate substances 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] no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. For five substances, the composition of the stereoisomeric mixture has to be specified further. The 37 candidate substances are 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, nonaromatic hydrocarbons and VI) macrocyclic, non-aromatic hydrocarbons.Several of the 37 flavouring substances possess chiral centres and/or can exist as geometrical isomers. For five of the flavouring substances [FL-no: 01.021, 01.027, 01.032, 01.035 and 01.078] the stereoisomeric composition/composition of mixture has not been specified sufficiently.Thirty-one of the 37 candidate substances belongs to structural class I, two belongs to structural class II and four to structural class III according to the decision tree approach presented by Cramer et al. (1978).Thirty-three out of the 37 candidate substances 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 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...

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“…One compound, β‐phellandrene [01.055], has been evaluated in FGE25. Rev2 (EFSA CEF Panel, 2011 ) by applying the procedure described in the Guidance on the data required for the risk assessment of flavourings to be used in or on food (EFSA CEF Panel, 2010 ). For this compound, for which there is no concern for genotoxicity, EFSA requested additional subchronic toxicity data (EFSA CEF Panel, 2011).…”

Safety and efficacy of a feed additive consisting of an essential oil from the fruit of Cuminum cyminum L. (cumin oil) for use in all animal species (FEFANA asbl)

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