Scientific Opinion on Flavouring Group Evaluation 78, Revision 2 (FGE.78Rev2): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63<sup>rd</sup> meeting) structurally related to aliphatic hydrocarbons evaluated by EFSA in FGE.25Rev3
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns 21 aromatic, aliphatic and alicyclic hydrocarbons [FL-no: 01.002, 01.003, 01.004, 01.005, 01.006, 01.007, 01.008, 01.009, 01.010, 01.016, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] evaluated by the JECFA in 2005. FGE.78Rev1 considered 24 substances, but 4-methyl-1,1'-biphenyl (JECFA-no: 1334) and biphenyl (JECFA-no: 1332) [former FL-no: 01.011 and 01.013] are no longer supported by Industry for use as a flavouring substance in Europe. Moreover 1-methylnaphthalene [FL-no: 01.014] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β-caryophyllene [FL-no: 01.007] and 90-day studies in rats on β-caryophyllene [FL-no: 01.007] and myrcene [FL-no: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons [FL-no: 01.002-01.010, 01.016-01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.