Flavouring Group Evaluation 208 Revision 1

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Article
First published in the EFSA Journal
23 July 2015
Adopted
24 June 2015
Type
Scientific Opinion
Abstract

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.

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 Toldrá, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2015.4173
EFSA Journal 2015;13(7):4173 [28 pp.].
On request from
FGE.19, subgroup 2.2, alicyclic aldehydes, α,β-unsaturated
Print on demand
Number of Pages
28