Scientific Opinion on Flavouring Group Evaluation 50, Revision 1 (FGE.50Rev1): Consideration of pyrazine derivatives evaluated by JECFA (57th meeting) structurally related to pyrazine derivatives evaluated by EFSA in FGE.17Rev2 (2010)

摘要

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. Since the previous version of FGE.50, new in vitro and in vivo genotoxicity data on 5‐methylquinoxaline [FL‐no: 14.028] have been provided. The Panel concluded that these data allowed to roule out genotoxicity concerns for the substance. 5‐Methylquinoxaline was then evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the substance do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. So in total, for all the 41 JECFA evaluated pyrazines derivatives [FL‐no: 14.005, 14.006, 14.015, 14.017, 14.018, 14.019, 14.020, 14.021, 14.022, 14.024, 14.025, 14.026, 14.027, 14.028, 14.031, 14.032, 14.034, 14.035, 14.037, 14.043, 14.044, 14.049, 14.050, 14.053, 14.054, 14.055, 14.056, 14.062, 14.067, 14.069, 14.077, 14.082, 14.095, 14.096, 14.098, 14.100, 14.114, 14.121, 14.123, 14.142 and 14.144] evaluated in FGE.50, the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 41 flavouring substances.