Scientific Opinion on Flavouring Group Evaluation 209 (FGE.209): Consideration of gentoxocity data on one alpha,beta-unsaturated aldehyde from chemical subgroup 2.3 of FGE.19 by EFSA EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission 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 209 (FGE.209), corresponding to subgroup 2.3 of FGE.19, concerns one cyclic aldehyde with the alpha,beta-unsaturation in conjugation with the ring system. The alpha,beta-unsaturated aldehyde and ketone structures are considered alerts for genotoxicity and the data on genotoxicity previously available did not rule out the concern for genotoxicity. Accordingly, the Panel has requested additional genotoxicity data for this substance, 2,6,6trimethylcyclohexa-1,3-diene-l-carbaldehyde FL-no:[ 05.1041, according to the test strategy. Subsequently, the Flavour Industry has performed new genotoxicity studies, and submitted in vitro genotoxicity data for 2,6,6-trimethylcyclohexa-1,3-diene-1-carbaldehyde. The Panel has examined these new data and concluded based on these that the in vitro genotoxicity data on 2,6,6-trimethylcyclohexa-1,3-diene-1-carbaldehyde [FL-no: 05.1041 do not indicate genotoxic potential. 2,6,6-Trimethylcyclohexa-1,3-diene-1-carbaldehyde [FL-no: 05.1041 will then be evaluated through the Procedure in Flavouring Group Evaluation 79, Revision 1 (FGE.79Rev1). (C) European Food Safety Authority, 2011