EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Scientific Opinion on Flavouring Group Evaluation 74, Revision 1 (FGE.74Rev1): 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.08Rev1 (2009)

Abstract

The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments. The JECFA has evaluated a group of 12 simple aliphatic sulphides and thiols at the 61st meeting and seven trisulphides in a group of simple aliphatic and aromatic sulphides and thiols at the 53rd meeting. One of the substances evaluated by the JECFA at its 61st meeting is not in the Register (spiro[2,4-dithia-1-methyl-8-oxabicyclo(3.3.0)octane-3,3'-(1'-oxa-2'-methyl)-cyclopentane], JECFA-no: 1296). Accordingly this consideration will deal with 18 JECFA evaluated substances. The Panel concluded that the 18 substances in the JECFA flavouring group of simple aliphatic sulphides and thiols are structurally related to the group of 66 aliphatic and alicyclic mono-, di-, and polysulphides with or without additional oxygenated functional groups evaluated by EFSA in the Flavouring Group Evaluation 08, Revision 1(FGE.08Rev1). The Panel agrees with the outcome of the application of the Procedure performed by the JECFA for eight of the 18 aliphatic sulphides and thiols [FL-no: 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291]. For two tertiary thiols, 2-methyl-4-oxopentane-2-thiol [FL-no: 12.169] and 2-mercapto-2-methylpentan-1-ol [FL-no: 12.241], the Panel concluded that they should not be evaluated through the Procedure, as they are structurally related to three tertiary thiols evaluated in FGE.08Rev1 which could not be evaluated through the Procedure due to concern with respect to genotoxicity in vitro. For the eight tri- and polysulphides [FL-no: FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280] the Panel did not agree with the JECFA that appropiate studies were available for deriving NOAELs, and accordingly additional data are required for these eight substances. For two substances [FL-no: 12.045 and 12.155] the JECFA evaluation is only based on MSDI values derived from production figures from the USA. EU production figures are needed in order to finalise the evaluation of these substances. For one substance use levels have been provided by the Industry. For the remaining 17 substances use levels must be provided. These are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation. In order to determine whether the conclusion for the 18 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity are available for 10 of the 18 JECFA evaluated substances. For seven substances [FL-no: 12.009, 12.020, 12.045, 12.169, 12.238, 12.239 and 12.291] information on secondary components and/or composition of mixture is requested. For six substances [FL-no: 12.009, 12.020, 12.023, 12.045, 12.074 and 12.155] no solubility in ethanol and/or solubility in water is available. Finally, the European production volumes are not available for [FL-no: 12.045 and 12.155]. Thus, for 10 substances [FL-no: 12.009, 12.020, 12.023, 12.045, 12.074, 12.155, 12.169, 12.238, 12.239 and 12.291] the Panel has reservations (no European production volumes are available, preventing them to be evaluated using the Procedure, and/or information on specifications). For two substances [FL-no: 12.169 and 12.241] the Procedure should not be applied until adequate genotoxicity data become available and for eight substances [FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280] additional toxicity data are required. For the remaining five of the 18 JECFA evaluated simple aliphatic sulphides and thiols [FL-no: 12.179, 12.198, 12.212, 12.255 and 12.257] the Panel agrees with JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.