TY - JOUR
T1 - Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1)
T2 - 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19
AU - EFSA Panel on Food Additives and Flavourings (FAF)
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Castle, Laurence
AU - Engel, Karl Heinz
AU - Fowler, Paul
AU - Frutos Fernandez, Maria Jose
AU - Fürst, Peter
AU - Gundert-Remy, Ursula
AU - Husøy, Trine
AU - Mennes, Wim
AU - Moldeus, Peter
AU - Oskarsson, Agneta
AU - Rainieri, Sandra
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wölfle, Detlef
AU - Binderup, Mona Lise
AU - Bolognesi, Claudia
AU - Marcon, Francesca
AU - Marzin, Daniel
AU - Mosesso, Pasquale
AU - Carfì, Maria
AU - Vianello, Giorgia
AU - Gürtler, Rainer
N1 - Publisher Copyright:
© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2018/10
Y1 - 2018/10
N2 - 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.
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.
KW - FGE.19
KW - FGE.200
KW - flavouring substances
KW - safety evaluation
KW - straight chain
KW - subgroup 1.1.1
KW - α,β-unsaturated aldehydes
UR - http://www.scopus.com/inward/record.url?scp=85062085768&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2018.5422
DO - 10.2903/j.efsa.2018.5422
M3 - Article
AN - SCOPUS:85062085768
SN - 1831-4732
VL - 16
JO - EFSA Journal
JF - EFSA Journal
IS - 10
M1 - e05422
ER -