Flavouring Group Evaluation 82 Revision 2 (FGE.82Rev2): Consideration of epoxides evaluated by JECFA

Abstract The Panel on Food Additives and Flavourings (FAF) 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 (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No. 1565/2000. The present consideration concerns a group of five epoxides evaluated by JECFA at the 65th meeting. This revision of FGE.82 is made due to new information on stereoisomeric composition, toxicity studies, uses and use levels for beta‐ionone epoxide [FL‐no: 07.170]. In addition, new data on uses and use levels for the substances [FL‐no: 16.015, 16.018, 16.040 and 16.043] have been provided and considered for the estimation of exposure (modified theoretical added maximum daily intake (mTAMDI) approach). The Panel considered that the information on the stereochemical composition of [FL‐no: 07.170] is sufficient. The Panel did not agree with the application of the Procedure for the epoxides as performed by JECFA, because in the absence of experimental data, the extent of detoxification of these epoxides remains uncertain. Therefore, [FL‐no: 07.170] was assessed via the B‐side of the Procedure. In the 90‐day toxicity study on [FL‐no: 07.170], substance‐related findings were observed in adrenal glands of male rats. Based on this observation, the Panel identified a no observed adverse effect level (NOAEL) of 39 mg/kg bw per day and concluded that for [FL‐no: 07.170] there is ‘no safety concern at estimated levels of intake as flavouring substance’, when based on the maximised survey‐derived daily intake (MSDI) approach. Based on new information on uses and use levels for [FL‐no: 07.170, 16.015, 16.018, 16.040 and 16.043], the mTAMDI exposure estimates are above the toxicological threshold of concern (TTC) for their structural class III. The Panel concluded that more reliable data on uses and use levels would be needed for these five substances.