Scientific Opinion on Flavouring Group Evaluation 220, Revision 2 (FGE.220Rev1): alpha,beta-Unsaturated ketones and precursors from chemical subgroup 4.4 of FGE.19:3(2H)-Furanones

被引:0
作者
Sundh, Ulla Beckman [1 ]
Binderup, Mona-Lise [1 ]
Bolognesi, Claudia [1 ]
Brimer, Leon [1 ]
Castle, Laurence [1 ]
Di Domenico, Alessandro [1 ]
Engel, Karl-Heinz [1 ]
Franz, Roland [1 ]
Gontard, Nathalie [1 ]
Guertler, Rainer [1 ]
Husoy, Trine [1 ]
Jany, Klaus-Dieter [1 ]
Kolf-Clauw, Martine [1 ]
Leclercq, Catherine [1 ]
Mennes, Wim [1 ]
Milana, Maria Rosaria [1 ]
Pratt, Iona [1 ]
Svensson, Kettil [1 ]
Pocas, Maria de Fatima Tavares [1 ]
Toldra, Fidel [1 ]
Woelfle, Detlef [1 ]
机构
[1] European Food Safety Author EFSA, Parma, Italy
关键词
alpha; beta-unsaturated ketones; 3(2H)-furanones; flavouring substances; safety evaluation;
D O I
10.2903/j.efsa.2013.3390
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
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 10 flavouring substances from subgroup 4.4 of FGE.19 in the Flavouring Group Evaluation 220 (FGE.220). FGE. 220 is subdivided into two subgroups (subgroup 4.4a containing [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE. 220, Revision 1, the Panel concluded, based on new submitted data, that for the substances in subgroup 4.4b there is no concern for genotoxicity. The Flavour Industry has now provided additional genotoxicity studies for two representative substances of subgroup 4.4a, 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. Based on the new data the Panel concluded that 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] does not give rise to concern with respect to genotoxicity. For 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] the concern for genotoxicity could not be ruled out and therefore the Panel requests a repetition of the submitted micronucleus study in the presence of S9-mix applying the same conditions and possibly in addition modified conditions, or a combined in vivo micronucleus and Comet assay, including analysis of liver. This is also applicable to 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no: 13.089] and 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no: 13.117], which are covered by the representative substance 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. The Flavour Industry has informed that 5-methylfuran- 3(2H)-one [FL-no: 13.157] is not in common use in the flavour industry and is no longer supported. (C) European Food Safety Authority, 2013
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页数:30
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  • [1] Benigni R., Netzeva T., Report on a QSAR model for prediction of genotoxicity of alpha, beta-unsaturated aldehydes in S. typhimurium TA100 and its application for predictions on alpha, beta-unsaturated aldehydes in Flavouring Group Evaluation 19 (FGE.19), (2007)
  • [2] Benigni R., Netzeva T., Report on a QSAR model for prediction of genotoxicity of alpha, beta-unsaturated ketones in S. typhimurium TA100 and its application for predictions on alpha, beta-unsaturated aldehydes in Flavouring Group Evaluation 19 (FGE.19), (2007)
  • [3] Bowen R., Reverse mutation in five histidine-requiring strains of Salmonella typhimurium, 4-Acetyl-2, 5-dimethylfuran-3(2H)-one, (2011)
  • [4] Eastmond D.A., Hartwig A., Anderson D., Anwar W.A., Cimino M.C., Dobrev I., Douglas G.R., Nohmi T., Phillips D.H., Vickers C., Mutagenicity testing for chemical risk assessment: update of the WHO/IPCS Harmonized Scheme, Mutagenesis, 24, 4, pp. 341-349, (2009)
  • [5] Commission Regulation No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of Regulation (EC) No 2232/96, Official Journal of the European Communities 19.7.2000, L 180, pp. 8-16, (2000)
  • [6] Commission Regulation No 1334/2008 of the European Parliament and Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods, Official Journal of the European Union 31.12.2008, L 354, pp. 34-50, (2008)
  • [7] Privat Communication forwarded to FLAVIS Secretariat, Danish Food Institute, Technical University of Denmark, dated 15 February 2012, Specification data related to substances in FGE.75Rev1 [FL-no: 13.010, 13.084, 13.085, 13.099 and 13.176], (2012)
  • [8] Minutes of the 26th Plenary meeting of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, (2008)
  • [9] Scientific opinion of the Statement of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids on Genotoxicity Test Strategy for Substances belonging to Subgroups of FGE.19, The EFSA Journal, 854, (2008)
  • [10] Scientific opinion of the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on List of alpha, beta-unsaturated aldehydes and ketones representative of FGE.19 substances for genotoxicity testing, The EFSA Journal 2008, 910, pp. 1-5, (2008)