Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gundert-Remy Ursula, Gürtler Rainer, Husøy Trine, Manco Melania, Moldeus Peter, Oskarsson Agneta, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Benigni Romualdo, Bolognesi Claudia, Chipman Kevin, Cordelli Eugenia, Degen Gisela, Marzin Daniel, Svendsen Camilla, Vianello Giorgia, Mennes Wim
EFSA J. 2020 Jun 10;18(6):e06154. doi: 10.2903/j.efsa.2020.6154. eCollection 2020 Jun.
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty-four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL-no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL-no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL-no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL-no: 12.169] representative for the tertiary monothiols [FL-no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 49 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL-no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL-no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.
应要求,欧洲食品安全局食品添加剂和调味剂小组依据欧盟委员会法规(EC)No 1565/2000中概述的程序,对归入调味剂组评估91(FGE.91)的49种调味物质进行评估。FGE.91及其修订版(FGE.91Rev1和FEG.91Rev2)中已审议了44种物质。关于本次FGE.91修订版3中审议的其余5种调味物质:两种([FL编号:12.065和12.079])在FGE.201Rev2中已就遗传毒性通过审核;两种([FL编号:12.169和12.241])最初被归入FGE.74Rev4,一种([FL编号:12.304])被归入FGE.08Rev5。小组认为调味物质[FL编号:12.169]可代表叔单硫醇类[FL编号:12.038、12.085、12.137、12.138、12.145、12.252、12.259、12.241和12.304]。这些物质通过逐步评估法进行评估,该方法整合了结构-活性关系、当前使用的摄入量、关注的毒理学阈值(TTC)以及代谢和毒性方面的现有数据。小组得出结论,依据“最大化调查得出的每日摄入量”(MSDI)方法估算,这49种物质在其膳食摄入水平下均不会引发安全担忧。还审议了商业用材料的规格,发现其适用于所有49种调味物质。对于通过FGE.91Rev2中的程序评估的5种物质[FL编号:12.077、12.162、12.265、12.267和17.036],没有正常和最大使用水平的数据。对于10种物质[FL编号:12.065、12.038、12.079、12.108、12.139、12.264、12.274、12.252、12.284和12.304],其经修正的理论添加最大每日摄入量(mTAMDI)估算值高于其结构类别对应的TTC。因此,对于这15种物质,应提供关于用途和使用水平的更详细数据,以便完善其暴露评估并完成其安全性评估。