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Research article - Peer-reviewed, 2020

Scientific opinion on flavouring group evaluation 91, revision 3 (FGE.Rev3): consideration of aliphatic, aromatic and a,b-unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th, and 76th meetings), structurally related to substances in FGE.08Rev5

Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Engel, Karl-Heinz; Fowler, Paul; Frutos Fernandez, Maria Jose; Fürst, Peter; Gundert-Remy, Ursula; Gürtler, Rainer; Husøy, Trine; Manco, Melania; Moldeus, Peter; Oskarsson, Agneta; Passamonti, Sabina; Shah, Romina; Waalkens-Berendsen, Ine; Wölfe, Detlef; Wright, Matthew; Benigni, Romualdo; Bolognesi, Claudia;
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Abstract

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty‐four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL‐no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL‐no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL‐no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL‐no: 12.169] representative for the tertiary monothiols [FL‐no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 49 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL‐no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL‐no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Keywords

Flavourings; a,b-unsaturated carbonyls and precursors; FGE.91Rev2; JECFA

Published in

EFSA Journal

2020, volume: 18, number: 6, article number: e06154

Authors' information

Younes, Maged
No organisation
Aquilina, Gabriele
No organisation
Castle, Laurence
No organisation
Engel, Karl-Heinz
No organisation
Fowler, Paul
No organisation
Frutos Fernandez, Maria Jose
No organisation
Fürst, Peter
No organisation
Gundert-Remy, Ursula
No organisation
Gürtler, Rainer
No organisation
Husøy, Trine
No organisation
Manco, Melania
No organisation
Moldeus, Peter
No organisation
Passamonti, Sabina
No organisation
Shah, Romina
No organisation
Waalkens-Berendsen, Ine
No organisation
Wölfe, Detlef
No organisation
Wright, Matthew
No organisation
Benigni, Romualdo
No organisation
Bolognesi, Claudia
No organisation
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UKÄ Subject classification

Public Health, Global Health, Social Medicine and Epidemiology

Publication Identifiers

DOI: https://doi.org/10.2903/j.efsa.2020.6154

URI (permanent link to this page)

https://res.slu.se/id/publ/110062