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, Brimer Leon, Mulder Gerard, Oskarsson Agneta, Svendsen Camilla, Anastassiadou Maria, Saarma Siiri, Mennes Wim
EFSA J. 2017 Nov 9;15(11):e05010. doi: 10.2903/j.efsa.2017.5010. eCollection 2017 Nov.
The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids 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 revision of FGE.73 concerns the inclusion of four additional flavouring substances (-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], -mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302]) evaluated by JECFA at the 59th meeting. The substances were evaluated through a stepwise approach integrating information on structure-activity relationships, intake from current uses, toxicological thresholds of concern (TTC), and available data on metabolism and toxicity. In agreement with JECFA, the Panel evaluated 22 and one candidate substances via the A and the B-side of the Procedure, respectively, and concluded for all substances 'No safety concern at estimated levels of intake as flavouring substances' based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity data, are available for 22 out of the 23 JECFA substances evaluated in this FGE. For [FL-no: 09.278], the stereoisomeric composition is not specified. For the six substances with [FL-no: 02.060, 02.091, 09.034, 09.278, 09.302 and 09.712] evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For two substances [FL-no: 09.034, and 09.712], the mTAMDI estimates were above the TTC for their structural class and more detailed information is needed to finalise their evaluation. For the remaining 17 substances evaluated through the Procedure, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment in order to finalise the evaluation.
应要求，欧洲食品安全局食品接触材料、酶、香料和加工助剂小组审议了自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，并根据委员会第1565/2000号（EC）条例的规定，决定是否有必要进行进一步评估。FGE.73的本次修订涉及纳入JECFA在第59次会议上评估的四种额外香料物质（-薄荷-1,8-二烯-7-醇[FL编号：02.060]、桃金娘烯醇[FL编号：02.091]、-薄荷-1,8-二烯-7-基乙酸酯[FL编号：09.278]和桃金娘烯基乙酸酯[FL编号：09.302]）。这些物质通过逐步方法进行评估，该方法整合了结构-活性关系、当前使用的摄入量、关注毒理学阈值（TTC）以及关于代谢和毒性的现有数据。与JECFA一致，该小组分别通过程序A侧和B侧评估了22种和1种候选物质，并根据最大化调查得出的每日摄入量（MSDI）方法得出结论：所有物质“作为香料物质按估计摄入量水平不存在安全问题”已考虑了商业材料的规格。在本FGE中评估的23种JECFA物质中的22种有足够的规格，包括完整的纯度标准和身份数据对于[FL编号：09.278]，未指定立体异构体组成。对于本FGE中评估的六种物质[FL编号：02.060、02.091、09.034、09.278、09.302 和 09.712]，已获得使用水平并估计了修改后的理论最大每日摄入量（mTAMDIs）。对于两种物质[FL编号：09.034 和 09.712]，其mTAMDI估计值高于其结构类别的TTC，需要更详细的信息来完成其评估。对于通过该程序评估的其余17种物质，需要使用水平来计算mTAMDIs以识别那些需要更精细暴露评估以完成评估的香料物质。
