Scientific Opinion on Flavouring Group Evaluation 78, Revision 2 (FGE.78Rev2): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic hydrocarbons evaluated by EFSA in FGE.25Rev3

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Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings: Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin Nørby and EFSA staff: Annamaria Rossi, Maria Carfi and Maria Anastassiadou for the support provided to this scientific opinion.

Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(4):4067 [72 pp.].
doi
10.2903/j.efsa.2015.4067
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2013-00185
EFSA-Q-2013-00186
EFSA-Q-2013-00187
EFSA-Q-2013-00188
EFSA-Q-2013-00189
EFSA-Q-2013-00190
EFSA-Q-2013-00191
EFSA-Q-2013-00192
EFSA-Q-2013-00845
EFSA-Q-2013-00846
EFSA-Q-2013-00847
EFSA-Q-2013-00848
Adopted
18 March 2015
Published
13 April 2015
Last Updated
1 June 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

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.

Keywords
flavouring, aliphatic, alicyclic, aromatic, hydrocarbons, JECFA, 63rd meeting, FGE.78Rev2, FGE.25Rev3
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Number of Pages
72