要求EFSA的食品添加剂和调味剂小组使用委员会法规(EC)第1565/2000号中概述的程序更新调味剂组评估13,以包括对调味物质2-乙基-5-甲基呋喃[FL-no:13.125]和2-辛基呋喃[FL-no:13.162]的评估。FGE.13修订版3(FGE.13Rev3)涉及26种调味品,其中24种已被评估为没有安全性问题。对于[FL-no:13.125]和[FL-no:13.162],在FGE.13Rev1中提出了对遗传毒性的关注。根据FGE.67Rev3中有关辅助物质的新遗传毒性数据,可以排除这种担忧。随后,[FL-no:13.125和13.162]进行了评估,通过逐步的方法,整合当前使用的摄入量,毒理学关注阈值(TTC),以及关于新陈代谢和毒性的现有数据,沿着程序的B面,使用每天8.51毫克/千克体重(bw)的BMDL。小组从使用支持物质2-戊基呋喃的口服亚慢性毒性研究中得出了该BMDL[FL-no:13.059]。使用此BMDL,对于[FL-no:13.125和13.162],足够的安全裕度是根据MSDI方法计算的。专家小组的结论是,FGE.13Rev3中的26种候选物质在其饮食摄入水平上不会引起安全问题,当根据MSDI方法估计时。已经为所有26种物质提供了足够的商业材料规格。[FL-no:13.130]需要使用和使用水平的数据。对于21种调味物质[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和13.185],mTAMDI摄入量估计值高于其结构类别的TTC,需要更可靠的使用和使用水平数据才能完成评估。
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.