Silano Vittorio, Bolognesi Claudia, Castle Laurence, Chipman Kevin, Cravedi Jean-Pierre, Engel Karl-Heinz, Fowler Paul, Franz Roland, Grob Konrad, Husøy Trine, Kärenlampi Sirpa, Mennes Wim, Milana Maria Rosaria, Pfaff Karla, Riviere Gilles, Srinivasan Jannavi, Tavares Poças Maria de Fátima, Tlustos Christina, Wölfle Detlef, Zorn Holger, Binderup Mona-Lise, Marcon Francesca, Marzin Daniel, Mosesso Pasquale, Anastassiadou Maria, Carfì Maria, Gürtler Rainer
EFSA J. 2018 Jul 20;16(7):e05322. doi: 10.2903/j.efsa.2018.5322. eCollection 2018 Jul.
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 flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(),4()-dienal [FL-no: 05.140] and hexa-2(),4()-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(),4()-dienal [FL-no: 05.057] did not induce gene mutations in mammalian cells. Hexa-2(),4()-dienal [FL-no: 05.057] was also tested in an gene mutation assay giving negative results. Both hexa-2(),4()-dienal [FL-no: 05.057] and deca-2(),4()-dienal [FL-no: 05.140] were tested for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(),4()-dienal [FL-no: 05.057] and deca-2(),4()-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.
应要求,欧洲食品安全局食品接触材料、酶、香料及加工助剂小组对香料组评估203修订版2(FGE.203Rev2)中FGE.19第1.1.4亚组的调味物质的遗传毒性潜力进行评估。在FGE.203修订版1中,该小组得出结论,不能排除该FGE中调味物质的遗传毒性潜力。香料行业为FGE.19第1.1.4亚组的代表性物质,即癸-2(E),4(E)-二烯醛[FL编号:05.140]和己-2(E),4(E)-二烯醛[FL编号:05.057]提供了额外的遗传毒性研究。此外,还提供了关于庚-2,4-二烯醛[FL编号:05.084]、2,4-辛二烯醛[FL编号:05.186]和反-2,反-4-壬二烯醛[FL编号:05.194]的新研究,这些研究在FGE.203的本次修订版即FGE.203Rev2中进行评估。庚-2,4-二烯醛[FL编号:05.084]、2,4-辛二烯醛[FL编号:05.186]和反-2,反-4-壬二烯醛[FL编号:05.194]在细菌中未诱导基因突变。己-2(E),4(E)-二烯醛[FL编号:05.057]在哺乳动物细胞中未诱导基因突变。己-2(E),4(E)-二烯醛[FL编号:05.057]也在一项基因突变试验中进行了测试,结果为阴性。己-2(E),4(E)-二烯醛[FL编号:05.057]和癸-2(E),4(E)-二烯醛[FL编号:05.140]在口服或腹腔注射后均在大鼠骨髓和外周网织红细胞中进行了微核诱导测试。这两种物质均未诱导微核频率增加。该小组得出结论,对于代表性物质己-2(E),4(E)-二烯醛[FL编号:05.057]和癸-2(E),4(E)-二烯醛[FL编号:05.140],以及因此该组中的其他物质[FL编号:02.139、02.153、02.162、02.188、05.064、05.071、05.081、05.084、05.101、05.108、05.125、05.127、05.141、05.173、05.186、05.194、05.196、09.573],可以排除对遗传毒性的担忧。这20种物质可使用调味物质评估程序进行评估。