Scientific Opinion on Flavouring Group Evaluation 74, Revision 2 (FGE.74Rev2): Consideration of Simple Aliphatic Sulphides and Thiols evaluated by the JECFA (53rd and 61st meeting) Structurally related to Aliphatic and Alicyclic Mono-, Di-, Tri-, and Polysulphides with or without Additional Oxygenated Functional Groups from Chemical Group 20 evaluated by EFSA in FGE.08Rev3 (2011)
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 publication of the last revision of this FGE the EFSA has been requested to evaluate one additional monosulphide [FL-no: 12.088] which has been included in the present version of FGE.74. Therefore, the present consideration concerns a group of 19 simple aliphatic sulphides and thiols evaluated by the JECFA at the 53rd meeting in 1999 and the 61st meeting in 2003. 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 eight substances [FL-no: 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291] 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 one substance [FL-no: 12.088], 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 eight substances [FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280], contrary to the JECFA, the Panel concluded that no adequate NOAEL exists and that additional toxicity data are required. For two of these substances [FL-no: 12.045 and 12.155], European production volumes are not available. Finally, for the two tertiary thiols [FL-no: 12.169 and 12.241], contrary to the JECFA, the Panel concluded that these two substances should not be evaluated using the Procedure due to concern for genotoxicity. So, the Panel concluded that nine substances [FL-no: 12.088, 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291 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: 12.238, 12.239 and 12.291] the stereoisomeric composition has to be specified.