Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Younes, Maged; Aquilina, Gabriele; Castle, Laurence; Degen, Gisela H.; Engel, Karl‐Heinz; Fowler, Paul; Fürst, Peter; Gundert‐Remy, Ursula; Gürtler, Rainer; Husøy, Trine; Manco, Melania; Moldéus, Peter; Passamonti, Sabina; Shah, Romina; Waalkens‐Berendsen, Ine; Wright, Matthew; Benigni, Romualdo; Bolognesi, Claudia; Chipman, Kevin; Cordelli, Eugenia; Carfì, Maria; Mennes, Wim

doi:10.2903/j.efsa.2023.7967

Cited by 1 publication

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References 7 publications

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“… 82nd JECFA report (JECFA, 2016a ) and 82nd JECFA toxicology monograph (JECFA, 2017 ). Genotoxicity data evaluated in FGE.217Rev3 (EFSA FAF Panel, 2023 ). EFSA scientific opinion on FGE.80 (EFSA, 2008a ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

“…2223 in its 82nd meeting (JECFA, 2016a , 2016b , 2017 ). This substance was evaluated by EFSA in FGE.217Rev3 (EFSA FAF Panel, 2023 ), where it was concluded that the concern for genotoxicity for [FL‐no: 10.057] could be ruled out. Therefore, it can be evaluated through the procedure for which purpose it has now been added to this revision 2 of FGE.80.…”

Section: Data and Methodologiesmentioning

confidence: 99%

“…The remaining two JECFA evaluated substances [FL‐no: 10.034 and 10.036], which were allocated to FGE.217 for evaluation of genotoxicity will not be considered further because these have been removed from the Union List 4 as explained in FGE.217Rev3 (EFSA FAF Panel, 2023 ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

“…3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2 (3H) ‐one [FL‐no: 10.057], which is a precursor for the α,β ‐unsaturated ketone 3‐methyl‐6‐(1‐carboxyethyl)‐2‐cyclohexen‐1‐one. The flavouring substance [FL‐no: 10.057] has been evaluated with respect to genotoxicity in FGE.217Rev3 (EFSA FAF Panel, 2023 ). According to the terms of reference of this mandate, once the concern for genotoxicity is ruled out for a flavouring substance, the European Food Safety Authority (EFSA) shall proceed to its full evaluation, taking into account the requirements of the Commission Regulation (EC) No 1565/2000 1 and of Regulation (EU) No 1334/2008.…”

Section: Introductionmentioning

confidence: 99%

“…The flavouring substance [FL‐no: 10.057] was first allocated to FGE.217Rev3 (EFSA FAF Panel, 2023 ) for evaluation with respect to genotoxicity. Based on new genotoxicity data submitted, in FGE.217Rev3, the Panel concluded that this flavouring substance does not give rise to concern with respect to genotoxicity and can accordingly be evaluated through the Procedure in the present revision of FGE.80 (FGE.80Rev2), in accordance with Commission Regulation (EC) No 1565/2000.…”

Section: Introductionmentioning

confidence: 99%

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Flavouring Group Evaluation 80, Revision 2 (FGE.80Rev2): Consideration of alicyclic, alicyclic‐fused and aromatic‐fused ring lactones evaluated by the JECFA (61st and 82nd meetings) structurally related to an aromatic lactone evaluated in FGE.27

Castle,

Andreassen,

Aquilina

et al. 2024

EFS2

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The EFSA Panel on Food Additives and Flavourings was requested to evaluate 14 flavouring substances assigned to the Flavouring Group Evaluation 80 (FGE.80), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirteen substances have already been considered in FGE.80 and its revision and in FGE.96 [FL‐no: 10.005, 10.024, 10.025, 10.050, 10.061, 10.069, 10.070, 10.072, 10.169, 13.009, 13.012, 13.161 and 16.055]. The remaining flavouring substance 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057] has been cleared with respect to genotoxicity in FGE.217Rev3 and it is considered in this revision 2 of FGE.80. The substance [FL‐no: 10.057] was evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, threshold of toxicological concern (TTC) and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 10.057] does not give rise to safety concerns at its levels of dietary intake, when estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered and the information provided was complete for [FL‐no: 10.057]. However, for the flavouring substance [FL‐no: 10.057] in the present revision and for eight substances evaluated in previous revisions, the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) values are above the TTC for their structural class (III). For four substances previously evaluated in FGE.80Rev1 and in FGE.96, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 13 flavouring substances, data on uses and use levels should be provided to finalise their safety evaluations. For [FL‐no: 10.050, 10.069 and 13.161], information on the composition of stereoisomeric mixtures is needed.

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