EFSA ; Scientific Opinion on Flavouring Group Evaluation 91, Revision 1 (FGE.91Rev1): Consideration of simple aliphatic and aromatic sulphides and thiols evaluated by JECFA (53rd and 68th meetings) structurally related to aliphatic and alicyclic mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups evaluated by EFSA in FGE.08Rev3 (2011)
Larsen, John Christian2; Nørby, Karin Kristiane2; Beltoft, Vibe Meister2; Lund, Pia2; Binderup, Mona-Lise1; Frandsen, Henrik Lauritz2
1 Division of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark2 National Food Institute, Technical University of Denmark3 Division of Food Chemistry, National Food Institute, Technical University of Denmark
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. The present consideration concerns a group of 47 simple aliphatic and aromatic sulphides and thiols evaluated by the JECFA at the 53rd meeting in 1999 and the 68th meeting in 2007. The revision is made due to consideration of two additional substances compared to previous version. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for 34 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Contrary to the JECFA, the Panel concluded for three substances [FL-no: 12.077, 12.108 and 12.162], which has been cleared by the JECFA at step B5 (the MSDI <1.5 μg person per day), that adequate NOAELs exist and accordingly concluded at step B4 no safety concern at the estimated level of intake. Furthermore, for the trisulphides [FL-no: 12.114 and 12.256], contrary to the JECFA, the Panel concluded that no adequate NOAEL exists and that additional toxicity data are required. For eight substances [FL-no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259 and 12.272] the Panel decided, also contrary to the JECFA, that the Procedure could not be applied due to concern for genotoxicity. So, the Panel concluded that 37 substances do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for three substances, [FL-no: 12.274, 12.284 and 15.049], information on the composition of stereoisomeric mixture is lacking.