Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Gundert-Remy Ursula, Husøy Trine, Manco Melania, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Benigni Romualdo, Chipman Kevin, Cordelli Eugenia, Degen Gisela, Carfí Maria, Vianello Giorgia, Mennes Wim
EFSA J. 2021 Nov 11;19(11):e06883. doi: 10.2903/j.efsa.2021.6883. eCollection 2021 Nov.
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2-hydroxy-4-methoxybenzaldehyde [FL-no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2-Hydroxy-4-methoxybenzaldehyde belongs to chemical group 23 (Commission Regulation (EC) No 1565/2000) and is structurally related to the hydroxy- and alkoxy-ring substituted benzyl derivatives evaluated in FGE.52 and in FGE.20Rev4. The Panel considered the structural/metabolic similarity sufficient to evaluate the candidate substance following a group-based approach according to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods. The information provided on the manufacturing process, the composition and the stability of [FL-no: 05.229] was considered sufficient. From studies carried out with this substance, the Panel concluded that there is no concern with respect to genotoxicity. Based on QSAR evaluation of possible metabolism, and based on information from structurally related substances, various metabolic routes can be anticipated, which only result in the formation of innocuous metabolites. The exposure estimates for [FL-no: 05.229] (24 and 60 μg/person per day for children and adults, respectively) were below the Threshold of Toxicological Concern (TTC) for its structural class (I). Accordingly, toxicity studies are not required and the Panel concluded at step A3 of the Procedure that 2-hydroxy-4-methoxybenzaldehyde is not of safety concern when used as a flavouring substance at the intended uses and use levels. Cumulative exposure estimates for 2-hydroxy-4-methoxybenzaldehyde and three structurally related substances (2.4 and 6.2 mg/kg body weight (bw) per day for adults and children, respectively) are above the TTC for structural class I, but below the ADI (acceptable daily intake) of 0-10 mg/kg bw per day for vanillin, which is one of these structurally related substances. Therefore, the cumulative exposure to these four substances [FL-no: 05.015, 05.018, 05.229 and 09.749] also does not raise a safety concern.
应要求，欧洲食品安全局食品添加剂和调味剂小组（FAF）根据欧盟法规（EC）No 1331/2008，对2-羟基-4-甲氧基苯甲醛[FL编号：05.229]作为一种新型调味物质的安全性进行评估。2-羟基-4-甲氧基苯甲醛属于第23类化学物质（欧盟委员会法规（EC）No 1565/2000），在结构上与FGE.52和FGE.20Rev4中评估的羟基和烷氧基环取代苄基衍生物相关。小组认为，根据欧洲食品安全局关于食品中使用的调味剂风险评估所需数据的指南，这种结构/代谢相似性足以采用基于组的方法对候选物质进行评估。所提供的关于[FL编号：05.229]制造工艺、成分和稳定性的信息被认为是充分的。根据对该物质进行的研究，小组得出结论，在遗传毒性方面不存在担忧。基于对可能代谢的定量构效关系评估，并基于结构相关物质的信息，可以预期各种代谢途径，这些途径只会导致形成无害的代谢物。[FL编号：05.229]的暴露估计值（儿童和成人分别为每天24和60μg/人）低于其结构类别（I）的毒理学关注阈值（TTC）。因此，不需要进行毒性研究，小组在程序的A3步骤得出结论，当2-羟基-4-甲氧基苯甲醛按预期用途和使用水平用作调味物质时，不存在安全问题。2-羟基-4-甲氧基苯甲醛和三种结构相关物质的累积暴露估计值（成人和儿童分别为每天2.4和6.2mg/kg体重（bw））高于结构类别I的TTC，但低于这些结构相关物质之一香草醛的每日允许摄入量（ADI）0-10mg/kg bw/天。因此，这四种物质[FL编号：05.015、05.018、05.229和09.749]的累积暴露也不会引起安全问题。
