PMID- 32625707 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231113 IS - 1831-4732 (Electronic) IS - 1831-4732 (Linking) VI - 16 IP - 10 DP - 2018 Oct TI - Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 alpha,beta-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19. PG - e05422 LID - 10.2903/j.efsa.2018.5422 [doi] LID - e05422 AB - The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2(trans)-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans-2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2(trans)-enal [FL-no: 05.073], trans-2-octenal [FL-no: 05.190] and nona-2(trans),6(cis)-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances. CI - (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. CN - EFSA Panel on Food Additives and Flavourings (FAF) FAU - Younes, Maged AU - Younes M FAU - Aquilina, Gabriele AU - Aquilina G FAU - Castle, Laurence AU - Castle L FAU - Engel, Karl-Heinz AU - Engel KH FAU - Fowler, Paul AU - Fowler P FAU - Frutos Fernandez, Maria Jose AU - Frutos Fernandez MJ FAU - Furst, Peter AU - Furst P FAU - Gundert-Remy, Ursula AU - Gundert-Remy U FAU - Husoy, Trine AU - Husoy T FAU - Mennes, Wim AU - Mennes W FAU - Moldeus, Peter AU - Moldeus P FAU - Oskarsson, Agneta AU - Oskarsson A FAU - Rainieri, Sandra AU - Rainieri S FAU - Shah, Romina AU - Shah R FAU - Waalkens-Berendsen, Ine AU - Waalkens-Berendsen I FAU - Wolfle, Detlef AU - Wolfle D FAU - Binderup, Mona-Lise AU - Binderup ML FAU - Bolognesi, Claudia AU - Bolognesi C FAU - Marcon, Francesca AU - Marcon F FAU - Marzin, Daniel AU - Marzin D FAU - Mosesso, Pasquale AU - Mosesso P FAU - Carfi, Maria AU - Carfi M FAU - Vianello, Giorgia AU - Vianello G FAU - Gurtler, Rainer AU - Gurtler R LA - eng PT - Journal Article DEP - 20181019 PL - United States TA - EFSA J JT - EFSA journal. European Food Safety Authority JID - 101642076 PMC - PMC7009627 OTO - NOTNLM OT - FGE.19 OT - FGE.200 OT - flavouring substances OT - safety evaluation OT - straight chain OT - subgroup 1.1.1 OT - alpha,beta-unsaturated aldehydes EDAT- 2018/10/19 00:00 MHDA- 2018/10/19 00:01 PMCR- 2018/10/19 CRDT- 2020/07/07 06:00 PHST- 2020/07/07 06:00 [entrez] PHST- 2018/10/19 00:00 [pubmed] PHST- 2018/10/19 00:01 [medline] PHST- 2018/10/19 00:00 [pmc-release] AID - EFS25422 [pii] AID - 10.2903/j.efsa.2018.5422 [doi] PST - epublish SO - EFSA J. 2018 Oct 19;16(10):e05422. doi: 10.2903/j.efsa.2018.5422. eCollection 2018 Oct.