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Scientific Opinion on Flavouring Group Evaluation 208 (FGE.208): 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 by EFSA

EFSA Journal 2013;11(4):3151 [25 pp.]. doi:10.2903/j.efsa.2013.3151
  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 Poças, Fidel Toldra and 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 and Pasquale Mosesso, for the preparatory work on this scientific opinion and the hearing experts: Vibe Beltoft, Pia Lund and Karin Nørby and EFSA staff: Maria Carfi and Kim Rygaard Nielsen for the support provided to 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-2012-00828 , EFSA-Q-2012-00829 , EFSA-Q-2012-00830 , EFSA-Q-2012-00831 , EFSA-Q-2012-00832 , EFSA-Q-2012-00833 , EFSA-Q-2012-00834 , EFSA-Q-2012-00835 , EFSA-Q-2012-00836 , EFSA-Q-2012-00837 Adopted: 19 March 2013 Published: 08 April 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 from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208. The Flavour Industry has provided additional genotoxicity studies for p-mentha-1,8-dien-7-al [FL-no: 05.117]. p-Mentha-1,8-dien-7-al will represent the other nine flavouring substances in FGE.208. Based on the presently available data the Panel concluded that some concern for the genotoxic potential of p-mentha-1,8-dien-7-al remains. In order to clarify the genotoxic potential of this substance, the Panel considered that further in vivo testing should be performed. To address this, an in vivo Comet assay, considering the first site of contact (e.g. stomach or duodenum) and liver, should be carried out according to the Scientific Report of EFSA on Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports.

© 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 requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.

The present Flavouring Group Evaluation 208 (FGE.208), corresponding to subgroup 2.2 of FGE.19, concerns three alicyclic aldehydes with the α,β-unsaturation in ring / side-chain and seven precursors for such. The α,β-unsaturated aldehyde structure, which is a structural alerts for genotoxicity and the data on genotoxicity previously available for these 10 substances, did not rule out the concern for genotoxicity.

The Panel identified one flavouring substance, p-mentha-1,8-dien-7-al [FL-no: 05.117], among the 10 substances in the present FGE.19 subgroup 2.2, for which appropriate genotoxicity data could be used for reading across to the other substances in the subgroup; therefore genotoxicity data have been requested for p-mentha-1,8-dien-7-al [FL-no: 05.117] according to the test strategy worked out by the Panel.

The Flavour Industry has provided additional genotoxicity data for p-mentha-1,8-dien-7-al [FL-no: 05.117].

Based on the presently available data, the Panel concluded that some concern for the genotoxic potential of p-mentha-1,8-dien-7-al [FL-no: 05.117] remains. In order to clarify the genotoxic potential of this substance, the Panel considered that further in vivo testing should be performed. To address this, an in vivo Comet assay, considering the first site of contact (e.g. stomach or duodenum) and liver, should be carried out according to the Scientific Report of EFSA on Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports.
 

Keywords

FGE.19; subgroup 2.2, alicyclic aldehydes; α,β-unsaturated