Abstract
Abstract The EFSA Panel on Food Additives and Flavourings (FAF) evaluated the genotoxic potential of two flavouring substances, 2‐phenylcrotonaldehyde [FL‐no: 05.062] and 5‐methyl‐2‐phenylhex‐2‐enal [FL‐no: 05.099] from subgroup 3.3 of FGE.19, in the Flavouring Group Evaluation 216 revision 3 (FGE.216Rev3). In FGE.216Rev2, the Panel concluded that the use of the flavouring [FL‐no: 05.062] at the reported use levels in several food categories would raise a concern for aneugenicity and requested substance‐specific data for the other related compounds [FL‐no: 05.099, 05.100, 05.175 and 05.222]. New data were provided only for [FL‐no: 05.062 and 05.099]. For [FL‐no: 05.062], the results of a new plasma analysis of the exposed animals were considered to be sufficient to rule out a concern for systemic aneugenicity of the substance. However, the data available do not overrule the concern for aneugenicity of 2‐phenylcrotonaldehyde at the site of contact, where the concentrations will be maximal, taking into account that the positive findings in the in vitro micronucleus (MN) assay were seen only in the absence of metabolic activation. Therefore, in line with the principles described in the EFSA Scientific Committee guidance on aneugenicity, the Panel compared the lowest concentration resulting in aneugenicity in the in vitro MN assay (20 μg/mL) with the reported use levels of 2‐phenylcrotonaldehyde [FL‐no: 05.062] in food (up to 2 mg/kg) and noted that they are one order of magnitude below the concentration for which an aneugenic effect was observed in the in vitro MN assay. Based on this comparison, the Panel concluded that the use of the flavouring substance [FL‐no: 05.062] in foods, including beverages, would not raise a concern for aneugenicity if the use levels were not greater than 2 mg/kg or mg/L. For [FL‐no: 05.099], based on the new data available, the Panel concluded that there is no concern for genotoxicity.