Scientific Opinion on Flavouring Group Evaluation 78, Revision 1 (FGE.78Rev1): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic and aromatic hydrocarbons evaluated by EFSA in FGE.25Rev2


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011; 9(6):2178 [69 pp.].
Panel Members
Arturo Anadon, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary Waring, Detlef Wölfle

The Panel wishes to thank the members of the Working Groups on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Catherine Leclercq, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerard Pascal, Iona Pratt, Gerrit Speijers, Harriet Wallin and EFSA’s staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
19 May 2011
Published in the EFSA Journal
29 June 2011
European Food Safety Authority (EFSA), Parma, Italy

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 a group of 24 aliphatic, alicyclic and aromatic hydrocarbons evaluated by the JECFA (65th meeting). In the previous version of FGE.78, the Panel concluded that for 13 substances no applicable NOAEL was available for the substance itself or on a structurally related compound and therefore further data were required. Additional data (long term study of toxicity, mutagenicity studies and new tonnage figure) have now become available for beta-myrcene [FL-no: 01.008] and the present revision of FGE.78, FGE.78Rev1, includes the evaluation of these data. 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. Two substances [FL-no: 01.011 and 01.013] are genotoxic in vitro and potentially carcinogenic, and are therefore not evaluated using the Procedure. The Panel concluded that the nine substance [FL-no: 01.002, 01.005, 01.006, 01.010, 01.016, 01.019, 01.020, 01.045 and 01.077] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. For 13 substances [FL-no: 01.003, 01.004, 01.007, 01.008, 01.009, 01.014, 01.017, 01.018, 01.024, 01.026, 01.029, 01.040 and 01.061] additional toxicity data are requested. For one substance [FL-no: 01.024] EU production figure is needed to finalise the evaluation. Besides the safety assessment of these substances, the specifications for the materials of commerce have been considered. For two substances [FL-no: 01.018 and 01.061] the isomeric composition is lacking. For 14 substances [FL-no: 01.004, 01.007, 01.008, 01.009, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045 and 01.061] further information on the composition of mixture is requested.

Safety, flavouring, aliphatic, alicyclic, aromatic, hydrocarbons, JECFA, 63rd meeting, FGE.25Rev2, FGE.78.
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