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Scientific Opinion on Flavouring Group Evaluation 65 (FGE.65): Consideration of sulfur-substituted furan derivatives used as flavouring agents evaluated by JECFA (59th meeting) structurally related to a subgroup of substances within the group of "Furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14" evaluated by EFSA in FGE.13Rev1 (2009)
No abstract available
The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked 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 present evaluation deals with 33 substances in the JECFA flavouring group of sulfur-substituted furan derivatives. These substances are structurally related to the group of sulfur-substituted furans evaluated within the group of “Furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14” evaluated by EFSA in Flavouring Group Evaluation 13, Revision 1 (FGE.13Rev1).
The Panel agrees with the way the application of the Procedure has been performed by the JECFA for all 33 candidate substances included in this FGE. For 23 substances the Panel also agreed with the JECFA with respect to the choice of the No Observed Adverse Effect Level (NOAEL) to finalise the evaluation. One substance was evaluated by the Panel based on comparison with other substances than the suggested substance by the JECFA. For five substances the NOAEL used by the JECFA was considered invalid, but the Panel could finalise the evaluations of these substances using NOAELs from other supporting substances. Thus, for 29 substances the Panel reached the same conclusion as the JECFA with respect to their use as chemically defined flavouring substances in food. However, for four further substances [FL-no: 13.056, 13.160, 13.193 and 13.194] no adequate NOAEL could be identified by the Panel and subsequently, no conclusion as to the safety when used at levels of intake estimated using the MSDI approach could be reached.
For all 33 substances evaluated through the Procedure by the JECFA use levels are needed to calculate the Modified Theoretical Added Maximum Daily Intake (mTAMDI) 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 33 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 25 of the 33 JECFA evaluated substances. For eight substances [FL-no: 13.075, 13.077, 13.078, 13.153, 13.160, 13.193, 13.194 and 13.196] information on the isomeric composition / composition of mixture has not been specified. For one substance [FL-no: 13.086] data on solubility in water is missing.
Thus, the Panel has reservations for nine substances: for eight substances [FL-no: 13.075, 13.077, 13.078, 13.153, 13.160, 13.193, 13.194 and 13.196] data on the stereoisomeric composition / composition of the mixture has not been specified and for four substances [FL-no: 13.056, 13.160, 13.193 and 13.194] additional toxicity data are needed.
For 24 of the 33 JECFA evaluated sulphur-substituted furan derivatives the Panel agrees with JECFA conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.
Sulphur-substituted furan derivatives; JECFA 59th meeting; FGE.13Rev1