Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched‐chain carboxylic acids from chemical group 5
2022
EFSA Panel on Food Additives | Flavourings (FAF) | Maged Younes | Gabriele Aquilina | Laurence Castle | Karl‐Heinz Engel | Paul J Fowler | Maria Jose Frutos Fernandez | Peter Fürst | Ursula Gundert‐Remy | Rainer Gürtler | Trine Husøy | Melania Manco | Peter Moldeus | Sabina Passamonti | Romina Shah | Ine Waalkens‐Berendsen | Detlef Wölfle | Matthew Wright | Romualdo Benigni | Claudia Bolognesi | Kevin Chipman | Eugenia Cordelli | Gisela Degen | Daniel Marzin | Karin Kristiane Nørby | Camilla Svendsen | Giorgia Vianello | Wim Mennes
Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 55 flavouring substances assigned to the Flavouring Group Evaluation 07 (FGE.07), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Fifty‐three substances have already been considered in FGE.07 and its revisions. This revision 6 includes two additional substances which have been cleared with respect to genotoxicity in FGE.201Rev2 (4‐methyl‐3‐hepten‐5‐one [FL‐no: 07.261]) and FGE.204Rev1 (non‐2‐en‐4‐one, [FL‐no: 07.187]). 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 the 55 substances gives rise to safety concerns at their 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 substances, the specifications for the materials of commerce have also been considered and found adequate. Normal and maximum use levels were available for all flavouring substances. For 52 substances, including the newly included substances [FL‐no: 07.187 and 07.261], their ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) estimates were above the TTC for their structural classes (I and II). Therefore, for these 52 flavouring substances, more detailed data on uses and use levels should be provided to finalise their safety evaluations.
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