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Scientific Opinion on Flavouring Group Evaluation 207 (FGE.207): Consideration of genotoxic potential for one branched-chain aliphatic acyclic α,β-unsaturated 2-alkylated aldehyde with additional double-bonds, from subgroup 1.1.2 of FGE.19 and four alicyclic aldehydes with the α,β-unsaturation in a side-chain, from subgroup 2.1 of FGE.19, which are considered to be covered by the one substance of subgroup 1.1.2, by EFSA

EFSA Journal 2013;11(5):3228[17 pp.]. doi:10.2903/j.efsa.2013.3228
  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Panel Members Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Kettil Svensson, Maria de Fatima Tavares Pocas, Fidel Toldra, Detlef Wölfle Acknowledgment The Panel wishes to thank the members of the Genotoxicity Working Group on Flavourings: Mona-Lise Binderup, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Rainer Gürtler, Daniel Marzin, Pasquale Mosesso, for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund, Karin Nørby and EFSA staff: Maria Carfi and Kim Rygaard Nielsen for the support provided to the formulation of this scientific opinion. Contact cef@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2013-00024,EFSA-Q-2013-00025,EFSA-Q-2013-00026,EFSA-Q-2013-00027,EFSA-Q-2013-00028 Adopted: 15 May 2013 Published: 17 May 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of one flavouring substance, 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931], from subgroup 1.1.2 of FGE.19, which is considered to be representative for four substances, 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712], from subgroup 2.1 of FGE.19. The Flavour Industry has provided genotoxicity studies for the representative substance 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] and these data are considered by EFSA to be representative for the four substances [FL-no: 02.216, 02.217, 09.034 and 09.712]. Based on the new data, the Panel concluded that 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] from FGE.19 subgroup 1.1.2 does not give rise to concern with respect to genotoxicity and can accordingly be evaluated using the Procedure. This conclusion can also be applied to the four substances 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712] from FGE.19 subgroup 2.1 for which 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] is representative.

© European Food Safety Authority,2013

Summary

Following a request from the European Commission the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member states. In particular, the Panel was asked to evaluate flavouring substances using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000.

The present Flavouring Group Evaluation 207 (FGE.207), corresponding to subgroup 2.1 of FGE.19, concerns the evaluation of genotoxicity data submitted on one α,β-unsaturated flavouring substance, 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931], from subgroup 1.1.2 of FGE.19 (FGE.201), which is considered to be representative for four substances, 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712], from subgroup 2.1 of FGE.19.

The α,β-unsaturated carbonyl structure is a structural alert for genotoxicity and the data on genotoxicity previously available for these FGE.19 subgroup 2.1 substances or structurally related flavouring substances did not rule out the concern for genotoxicity.

The Flavour Industry has provided new genotoxicity data for 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] from subgroup 1.1.2 of FGE.19 (FGE.201), requested in FGE.201. These data are considered by the Panel to be representative for the four substances [FL-no: 02.216, 02.217, 09.034 and 09.712] from FGE.19 subgroup 2.1 due to the fact that all five substances have the α,β-unsaturation in an aliphatic side-chain and are methylated in the α-position of the α,β-unsaturation.

Based on the new data, the Panel concluded that 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] does not give rise to concern with respect to genotoxicity and accordingly it can be evaluated through the Procedure. This conclusion can also be applied to the four substances 12-beta-santalen-14-ol [FL-no: 02.216], 12-alpha-santalen-14-ol [FL-no: 02.217], santalyl acetate [FL-no: 09.034] and santalyl phenylacetate [FL-no: 09.712] from FGE.19 subgroup 2.1 for which 2,6-dimethyl-2,5,7-octatriene-1-ol acetate [FL-no: 09.931] is representative.

Keywords

FGE.207, α,β-unsaturated alicyclic aldehydes, α,β-unsaturated, α,β-unsaturated in side-chain, Subgroup 1.1.2, Subgroup 2.1, FGE.19