Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gundert-Remy Ursula, Gürtler Rainer, Husøy Trine, Moldeus Peter, Oskarsson Agneta, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Benigni Romualdo, Bolognesi Claudia, Chipman Kevin, Cordelli Eugenia, Degen Gisela, Marzin Daniel, Svendsen Camilla, Carfì Maria, Mennes Wim
EFSA J. 2019 Nov 11;17(11):e05875. doi: 10.2903/j.efsa.2019.5875. eCollection 2019 Nov.
The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic . For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted.
应要求，欧洲食品安全局食品添加剂和调味剂小组对调味剂组评估215修订版1（FGE.215Rev1）中FGE.19第3.2亚组的调味物质的遗传毒性潜力进行评估。在FGE.215中，食品接触材料、酶、调味剂和加工助剂小组得出结论，不能排除对遗传毒性的担忧，并要求提供两种代表性物质4-苯基丁-3-烯-2-酮[FL编号：07.024]和1-(4-甲氧基苯基)戊-1-烯-3-酮[FL编号：07.030]的数据。香料行业已为这两种代表性物质[FL编号：07.024]和[FL编号：07.030]提供了额外的遗传毒性研究。基于这些新数据，该小组得出结论，对于代表性物质[FL编号：07.024]以及结构相关物质4-苯基丁-3-烯-2-醇[FL编号：02.066]和3-甲基-4-苯基丁-3-烯-2-酮[FL编号：07.027]，可以排除对遗传毒性的担忧，因此可以通过FGE.69中的程序进行评估。对于代表性物质1-(4-甲氧基苯基)戊-1-烯-3-酮[FL编号：07.030]，该小组得出结论，[FL编号：07.030]具有非整倍体诱导性。对于此类物质，目前尚无商定的后续策略来完成其安全性评估。该小组意识到欧洲食品安全局科学委员会将解决这一问题，一份澄清非整倍体诱导性物质评估的声明正在编写中。因此，该小组得出结论，目前，代表性物质1-(4-甲氧基苯基)戊-1-烯-3-酮[FL编号：07.030]以及结构相关物质香兰素丙酮[FL编号：07.046]和1-(4-甲氧基苯基)-4-甲基戊-1-烯-3-酮[FL编号：07.049]无法通过该程序进行评估。该小组进一步得出结论，由于存在甲基，4-(2,3,6-三甲基苯基)丁-3-烯-2-酮[FL编号：07.206]应被视为独立物质，因此，要求提供[FL编号：07.206]的遗传毒性数据。行业表示不再支持对[FL编号：07.206]的评估，因此未提交额外数据。
