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):e06386. doi: 10.2903/j.efsa.2021.6386. eCollection 2021 Feb.
The Panel on Food additives and Flavourings of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2-ethyl-5-methylfuran [FL-no: 13.125] and 2-octylfuran [FL-no: 13.162]. FGE.13 revision 3 (FGE.13Rev3) deals with 26 flavourings substances of which 24 have been already evaluated to be of no safety concern. For [FL-no: 13.125] and [FL-no: 13.162], a concern for genotoxicity was raised in FGE.13Rev1. This concern could be ruled out based on new genotoxicity data on supporting substances in FGE.67Rev3. Subsequently, [FL-no: 13.125 and 13.162] were evaluated, through a stepwise approach that integrates intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity, along the B-side of the Procedure, making use of a BMDL of 8.51 mg/kg body weight (bw) per day. The Panel derived this BMDL from an oral subchronic toxicity study with the supporting substance 2-pentylfuran [FL-no: 13.059]. Using this BMDL, for [FL-no: 13.125 and 13.162], adequate margins of safety were calculated based on the MSDI approach. The Panel concluded that the 26 candidate substances in FGE.13Rev3 do not give rise to safety concerns at their levels of dietary intake, when estimated on the basis of the MSDI approach. Adequate specifications for the materials of commerce have been provided for all 26 substances. Data on uses and use levels are needed for [FL-no: 13.130]. For 21 flavouring substances [FL-no: 13.011, 13.102, 13.108, 13.113, 13.114, 13.122, 13.125, 13.127, 13.129, 13.132, 13.133, 13.135, 13.136, 13.139, 13.141, 13.143, 13.146, 13.149, 13.162, 13.178 and 13.185], the mTAMDI intake estimates are above the TTC for their structural class and more reliable data on uses and use levels are required to finalise their evaluation.
欧洲食品安全局（EFSA）的食品添加剂和调味剂小组被要求按照欧盟委员会法规（EC）No 1565/2000中概述的程序更新调味剂组评估13，以纳入对调味物质2-乙基-5-甲基呋喃[FL编号：13.125]和2-辛基呋喃[FL编号：13.162]的评估。FGE.13修订版3（FGE.13Rev3）涉及26种调味物质，其中24种已被评估为无安全问题。对于[FL编号：13.125]和[FL编号：13.162]，在FGE.13Rev1中提出了对遗传毒性的担忧。基于FGE.67Rev3中关于支持物质的新遗传毒性数据，可以排除这种担忧。随后，通过一种逐步方法对[FL编号：13.125和13.162]进行了评估，该方法整合了当前使用的摄入量、关注的毒理学阈值（TTC）以及关于代谢和毒性的现有数据，沿着程序的B侧进行，使用的每日每千克体重（bw）的基准剂量下限（BMDL）为8.51毫克。该小组从对支持物质2-戊基呋喃[FL编号：13.059]的口服亚慢性毒性研究中得出此BMDL。使用此BMDL，对于[FL编号：13.125和13.162]，基于MSDI方法计算了足够的安全边际。该小组得出结论，当根据MSDI方法进行估计时，FGE.13Rev3中的26种候选物质在其膳食摄入量水平上不会引起安全问题。已为所有26种物质提供了商业材料的适当规格。对于[FL编号：13.130]，需要使用和使用水平的数据。对于21种调味物质[FL编号：13.011、13.102、13.108、13.113、13.114、13.122、13.125、13.127、13.129、13.132、13.133、13.135、13.136、13.139、13.141、13.143、13.146、13.149、13.162、13.178和13.185]，其mTAMDI摄入量估计高于其结构类别的TTC，需要更可靠的使用和使用水平数据来完成其评估。
