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Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 alicyclic aldehydes with the α,β-unsaturation in ring / side-chain and precursors from chemical subgroup 2.2 of FGE.19


  • EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

  • Panel members: 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 Toldrá, Detlef Wölfle and Holger Zorn.
  • Correspondence: fip@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Genotoxicity Working Group on Flavourings: Mona-Lise Binderup, Claudia Bolognesi, Riccardo Crebelli, Rainer Gürtler, Natalia Kovalkovicova, Francesca Marcon, Daniel Marzin and Pasquale Mosesso for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft and Karin Nørby, and EFSA staff: Annamaria Rossi and Maria Carfi for the support provided to this scientific opinion.
  • Adoption date: 24 June 2015
  • Published date: 23 July 2015
  • Question number: EFSA-Q-2014-00378, EFSA-Q-2014-00379, EFSA-Q-2014-00380, EFSA-Q-2014-00381, EFSA-Q-2014-00382, EFSA-Q-2014-00383, EFSA-Q-2014-00384, EFSA-Q-2014-00385, EFSA-Q-2014-00386, EFSA-Q-2014-00387
  • On request from: European Commission


The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1). The Flavour Industry has provided additional genotoxicity studies on p-mentha-1,8-dien-7-al [FL-no: 05.117], the representative substance for FGE.19 subgroup 2.2. This substance was tested in vivo in a combined micronucleus assay in bone marrow and Comet assay in liver and duodenum. It did not induce any increase in micronucleated polychromatic erythrocytes of the bone marrow of male rats in the micronucleus test and it did not induce DNA damage in duodenum of the same animals as analysed by the Comet assay. The Comet assay performed in liver shows a positive result and therefore the Panel concluded that p-mentha-1,8-dien-7-al [FL-no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p-mentha-1,8-dien-7-al [FL-no: 05.117] is representative for the nine remaining substances of this subgroup 2.2 (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], myrtenal [FL-no: 05.106], 2,6,6-trimethyl-1-cyclohexen-1-carboxaldehyde [FL-no: 05.121], myrtenyl formate [FL-no: 09.272], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278], myrtenyl acetate [FL-no: 09.302], myrtenyl-2-methylbutyrate [FL-no: 09.899] and myrtenyl-3-methylbutyrate [FL-no: 09.900]), there is a potential safety concern for these substances.