TY - RPRT
T1 - 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)
AU - EFSA Publication
AU - Larsen, John Christian
AU - Nørby, Karin Kristiane
AU - Beltoft, Vibe Meister
AU - Lund, Pia
AU - Binderup, Mona-Lise
AU - Frandsen, Henrik Lauritz
PY - 2011
Y1 - 2011
N2 - 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.
AB - 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.
M3 - Report
T3 - the EFSA Journal
BT - 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)
PB - European Food Safety Authority
CY - Parma, Italy
ER -