The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to evaluate three flavouring substances, 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no: 13.117], 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-Acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in the Flavouring Group Evaluation 313 (FGE.313), using the Procedure in Commission Regulation (EC) No 1565/2000. The substances were considered in FGE.220, and revisions hereof, not to have genotoxic potential. They were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the two flavouring substances [FL-no: 13.117, 13.119] do not give rise to safety concerns at their level of dietary intake, estimated on the basis of the Maximised Survey-derived Daily Intake (MSDI) approach. For the flavouring substance [FL-no: 13.175], toxicity data are required. Besides the safety assessment of the flavouring substance, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for the three flavouring substances. The Panel concluded that for 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no: 13.117], 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] for which the Modified Theoretical Added Maximum Daily Intakes (mTAMDIs) are above the thresholds for their structural class, more reliable exposure data are required for a re-evaluation.
EFSA Publication (2016). EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on Flavouring Group Evaluation 313, (FGE.313): α,β-unsaturated 3(2H)-furanone derivatives from chemical group 13. Europen Food Safety Authority. the EFSA Journal, No. 4531, Vol.. 14(7) https://doi.org/10.2903/j.efsa.2016.4531