The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) is asked to advise 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 Scientific Panel is asked to evaluate flavouring substances using the procedure as referred to in the Commission Regulation EC No 1565/2000.
The present revision of FGE.213, FGE.213Rev1 is due to additional genotoxicity data submitted by the Industry in response to genotoxicity data requests presented in FGE.213. New genotoxicity studies have been submitted for the five substances beta-ionone [FL-no: 07.008], maltol [FL-no: 07.014], beta-damascone [FL-no: 07.083], nootkatone [FL-no: 07.089] and 2,6,6-trimethylcyclohex-2-en-1,4-dione [FL-no: 07.109].
The Flavouring Group Evaluation 213 concerns 26 substances, corresponding to subgroup 2.7 of FGE.19. Twenty-three of the substances are α,β-unsaturated alicyclic ketones [FL-no: 07.008, 07.010, 07.014, 07.041, 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.083, 07.089, 07.108, 07.109, 07.117, 07.118, 07.119, 07.120, 07.127, 07.136, 07.168, 07.200 and 07.224] and three are precursors for such ketones [FL-no: 02.106, 09.305 and 09.525].
In the first version of FGE.213 the Panel concluded that the genotoxicity concern for ethyl maltol [FL-no: 07.047], 3-ethylcyclopentan-1,2-dione [FL-no: 07.057] and the nine structurally related substances [FL-no: 07.117, 07.118, 07.119, 07.120, 07.056, 07.168, 07.075, 07.076 and 07.080] could be ruled out and the 11 substances could accordingly be evaluated through the Procedure.
For maltol [FL-no: 07.014], a micronucleus assay after oral application was required in addition to an in vivo Comet assay in order to clarify the genotoxic potential. The outcome would also be applicable to maltyl isobutyrate [FL-no: 09.525].
The remaining 13 substances (including two precursors of a ketone) [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] could not be evaluated through the Procedure. Accordingly, additional data on genotoxicity were required for representatives of these 13 substances.
The flavouring Industry has informed that it does not longer support the representative flavouring substance, piperitenone oxide [FL-no: 16.044], for which the Panel requested additional data. Since the previous version of the FGE, one additional substance has been included in subgroup 2.7, tr-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)but-2-en-1-one [FL-no: 07.224], which is structurally related to the other substances for which the genotoxic potential could not be ruled out.
In FGE.213Rev1 the Panel has evaluated the new data submitted by the Industry in response to the data request presented in FGE.213. Based on these new data the Panel concluded that the genotoxicity concern could be ruled out for the representative substances beta-ionone [FL-no: 07.008], beta-damascone [FL-no: 07.083], nootkatone [FL-no: 07.089], 2,6,6-trimethylcyclohex-2-en-1,4-dione [FL-no: 07.109] and the nine substances that they represent, being [FL-no: 02.106, 07.010, 07.041, 07.108, 07.127, 07.136, 07.200, 07.224 and 09.305].
The Panel considered also the new data submitted for maltol [FL-no: 07.014] and concluded that for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525] the concern for genotoxicity could not be ruled out.