Silano Vittorio, Bolognesi Claudia, Castle Laurence, Chipman Kevin, Cravedi Jean-Pierre, Engel Karl-Heinz, Fowler Paul, Franz Roland, Grob Konrad, Gürtler Rainer, Husøy Trine, Kärenlampi Sirpa, Milana Maria Rosaria, Pfaff Karla, Riviere Gilles, Srinivasan Jannavi, Tavares Poças Maria de Fátima, Tlustos Christina, Wölfle Detlef, Zorn Holger, Benigni Romualdo, Binderup Mona-Lise, Brimer Leon, Marcon Francesca, Marzin Daniel, Mosesso Pasquale, Mulder Gerard, Oskarsson Agneta, Svendsen Camilla, van Benthem Jan, Anastassiadou Maria, Carfì Maria, Mennes Wim
EFSA J. 2018 Apr 25;16(4):e05226. doi: 10.2903/j.efsa.2018.5226. eCollection 2018 Apr.
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 22 pyridine, pyrrole and quinoline derivatives evaluated by JECFA (63rd meeting). The revision of this consideration is made since additional genotoxicity data have become available for 6-methylquinoline [FL-no: 14.042]. The genotoxicity data available rule out the concern with respect to genotoxicity and accordingly the substance is evaluated through the Procedure. For all 22 substances [FL-no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 14.042, 14.045, 14.046, 14.047, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.068, 14.071, 14.072 and 14.164] considered in this Flavouring Group Evaluation (FGE), the Panel agrees with the JECFA conclusion, 'No safety concern at estimated levels of intake as flavouring substances' based on the Maximised Survey-derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been evaluated, and the information is considered adequate for all the substances. For the following substances [FL-no: 13.134, 14.001, 14.030, 14.041, 14.042, 14.058, 14.072], the Industry has submitted use levels for normal and maximum use. For the remaining 15 substances, use levels are needed to calculate the modified Theoretical Added Maximum Daily Intakes (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.
欧洲食品安全局食品接触材料、酶、香料和加工助剂小组被要求审议自2000年以来由联合国粮食及农业组织/世界卫生组织食品添加剂联合专家委员会（JECFA）评估的香料物质，并根据欧盟委员会第1565/2000号法规的规定，决定是否有必要进行进一步评估。本次审议涉及JECFA（第63次会议）评估的一组22种吡啶、吡咯和喹啉衍生物。由于已获得6-甲基喹啉[FL编号：14.042]的更多遗传毒性数据，因此对本次审议进行了修订。现有的遗传毒性数据排除了对遗传毒性的担忧，因此该物质通过该程序进行评估。对于本香料组评估（FGE）中考虑的所有22种物质[FL编号：13.134、14.001、14.004、14.007、14.030、14.038、14.039、14.041、14.042、14.045、14.046、14.047、14.058、14.059、14.060、14.061、14.065、14.066、14.068、14.071、14.072和14.164]，小组同意JECFA的结论，即“根据最大调查得出的每日摄入量（MSDI）方法，在估计的香料物质摄入量水平上不存在安全问题”。除了对这些香料物质进行安全评估外，还对商业材料的规格进行了评估，并且认为所有物质的信息都足够。对于以下物质[FL编号：13.134、14.001、14.030、14.041、14.042、14.058、14.072]，行业已提交正常使用和最大使用水平。对于其余15种物质，需要使用水平来计算修改后的理论添加最大每日摄入量（mTAMDIs），以便确定那些需要更精细暴露评估的香料物质并完成评估。
