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, 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, Carfì Maria, Vianello Giorgia, Mennes Wim
EFSA J. 2021 Feb 3;19(2):e06362. doi: 10.2903/j.efsa.2021.6362. eCollection 2021 Feb.
The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already been considered in FGE.67 and its revisions (FGE.67Rev1 and FGE.67Rev2). During the current assessment, two substances were no longer supported by industry, therefore 12 candidate substances are evaluated in FGE.67Rev3. New genotoxicity and toxicity data are available for 2-pentylfuran [FL-no: 13.059] and 2-acetylfuran [FL-no: 13.054], which are representative substances of subgroup IV [FL-no: 13.069, 13.106, 13.148] and VI-B [FL-no: 13.045, 13.070, 13.083, 13.101, 13.105, 13.138, 13.163], respectively. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for both [FL-no: 13.054] and [FL-no: 13.059] and consequently for the substances that they represent. Since the candidate substances cannot be anticipated to be metabolised to innocuous products only, they were evaluated along the B-side of the Procedure. The Panel derived a NOAEL of 22.6 mg/kg bw per day and a BMDL of 8.51 mg/kg bw per day, for 2-acetylfuran and 2-pentylfuran, respectively. For all 12 substances sufficient margins of safety were calculated when based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 23 flavouring substances. The Panel agrees with JECFA conclusions, for all 23 substances, 'No safety concern at estimated levels of intake as flavouring substances' based on the MSDI approach. For 18 substances [FL-no: 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.054, 13.059, 13.074, 13.083, 13.101, 13.105, 13.106, 13.138, 13.148, 13.163 and 13.190], the mTAMDI intake estimates are above the threshold of toxicological concern (TTC) for their structural classes and more reliable data on uses and use levels are required to finalise their evaluation.
食品添加剂和调味剂专家委员会（FAF）被要求按照欧盟委员会第1565/2000号法规所述程序，审议食品添加剂联合专家委员会（JECFA）对归入调味剂组评估67（FGE.67Rev3）的25种调味物质的评估。FGE.67及其修订版（FGE.67Rev1和FGE.67Rev2）已经审议了11种物质。在本次评估期间，两种物质不再得到行业支持，因此FGE.67Rev3中评估了12种候选物质。2-戊基呋喃[FL编号：13.059]和2-乙酰基呋喃[FL编号：13.054]有新的遗传毒性和毒性数据，它们分别是IV亚组[FL编号：13.069、13.106、13.148]和VI-B亚组[FL编号：13.045、13.070、13.083、13.101、13.105、13.138、13.163]的代表性物质。基于这些数据，专家委员会得出结论，[FL编号：13.054]和[FL编号：13.059]以及它们所代表的物质不存在遗传毒性问题。由于无法预期候选物质仅代谢为无害产物，因此按照程序的B侧对它们进行了评估。专家委员会分别得出2-乙酰基呋喃和2-戊基呋喃的每日无观察到有害作用水平（NOAEL）为22.6毫克/千克体重和基准剂量下限（BMDL）为8.51毫克/千克体重。对于所有这12种物质，基于最大可能摄入量（MSDI）方法计算出了足够的安全边际。对于所有23种调味物质都有适用于商业用途物质的规范。专家委员会同意JECFA对所有23种物质的结论，即基于MSDI方法，“在估计的作为调味物质的摄入量水平下不存在安全问题”。对于18种物质[FL编号：13.021、13.022、13.023、13.024、13.031、13.045、13.047、13.054、13.059、13.074、13.083、13.101、13.105、13.106、13.138、13.148、13.163和13.190]，其基于mTAMDI的摄入量估计高于其结构类别的毒理学关注阈值（TTC），需要更可靠的使用和使用水平数据来完成对它们的评估。
