Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gundert-Remy Ursula, Gürtler Rainer, Husøy Trine, Moldeus Peter, Oskarsson Agneta, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Benigni Romualdo, Bolognesi Claudia, Chipman Kevin, Cordelli Eugenia, Degen Gisela, Marzin Daniel, Svendsen Camilla, Martino Carla, Mennes Wim
EFSA J. 2020 Jan 9;18(1):e05924. doi: 10.2903/j.efsa.2020.5924. eCollection 2020 Jan.
The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.71 [FL-no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. The remaining 30 substances [FL-no: 02.020, 02.050, 02.090, 02.112, 02.137, 02.156, 02.210, 05.037, 05.060, 05.070, 05.073, 05.076, 05.078, 05.102, 05.109, 05.150, 05.171, 05.179, 09.276, 09.277, 09.303, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.678 and 09.841] have been cleared with respect to genotoxicity in FGE.200Rev1 and they are considered in this revision. 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 the 39 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. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL-no: 08.073 and 09.235]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Normal and maximum use levels should be provided for nine flavouring substances [FL-no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. For two flavouring substances [FL-no: 02.020 and 05.076], the 'modified Theoretical Added Maximum Daily Intake' (mTAMDI) estimates are above the TTC for their structural class I. Therefore, additional information on uses and use levels should be provided for these eleven substances in order to finalise their evaluation.
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中的程序,对39种归入调味剂组评估71(FGE.71)的调味物质进行评估。FGE.71已对9种物质进行过评估[FL编号:08.054、08.073、08.123、09.037、09.156、09.157、05.158、09.235、09.239]。其余30种物质[FL编号:02.020、02.050、02.090、02.112、02.137、02.156、02.210、05.037、05.060、05.070、05.073、05.076、05.078、05.102、05.109、05.150、05.171、05.179、09.276、09.277、09.303、09.385、09.394、09.395、09.396、09.397、09.398、09.399、09.678和09.841]在FGE.200Rev1中已通过遗传毒性评估,此次修订对其进行审议。通过逐步整合结构 - 活性关系、当前使用摄入量、关注的毒理学阈值(TTC)以及代谢和毒性方面的现有数据等信息,对这些物质进行评估。该小组得出结论,基于“最大化调查得出的每日摄入量”(MSDI)方法估算,这39种物质在其膳食摄入水平下均不会引发安全担忧。除了对调味物质进行安全评估外,还对商业用材料的规格进行了审议,发现除了[FL编号:08.073和09.235]外均足够。对于这两种物质,应要求提供立体异构体混合物组成的数据。应为9种调味物质[FL编号:08.054、08.073、08.123、09.037、09.156、09.157、05.158、09.235、09.239]提供正常和最大使用水平。对于两种调味物质[FL编号:02.020和05.076],其“修正的理论最大每日摄入量”(mTAMDI)估算值高于其结构类别I的TTC。因此,应为这11种物质提供有关用途和使用水平的更多信息,以便完成对它们的评估。