TY - GEN
T1 - Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double-bonds and with or without additional non-conjugated double-bonds
AU - Silano, Vittorio
AU - Bolognesi, Claudia
AU - Castle, Laurence
AU - Chipman, Kevin
AU - Cravedi, Jean-Pierre
AU - Engel, Karl-Heinz
AU - Fowler, Paul
AU - Franz, Roland
AU - Grob, Konrad
AU - Husøy, Trine
AU - Kärenlampi, Sirpa
AU - Mennes, Wim
AU - Milana, Maria Rosaria
AU - Pfaff, Karla
AU - Riviere, Gilles
AU - Srinivasan, Jannavi
AU - Tavares Poças, Maria de Fátima
AU - Tlustos, Christina
AU - Wölfle, Detlef
AU - Zorn, Holger
AU - Binderup, Mona-Lise
AU - Marcon, Francesca
AU - Marzin, Daniel
AU - Mosesso, Pasquale
AU - Anastassiadou, Maria
AU - Carfì, Maria
AU - Gürtler, Rainer
AU - EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
N1 - cknowledgements: The Panel wishes to thank the hearing experts: Vibe Beltoft and Karin Nørbyand EFSA staff: Annamaria Rossi for the support provided to this scientic output.
PY - 2021/7/20
Y1 - 2021/7/20
N2 - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.
AB - The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 1.1.4 of FGE.19 in the Flavouring Group Evaluation 203 Revision 2 (FGE.203Rev2). In FGE. 203 Revision 1, the Panel concluded that the genotoxic potential could not be ruled out for the flavouring substances in this FGE. The Flavour Industry provided additional genotoxicity studies for the representative substances of FGE.19 subgroup 1.1.4, namely deca-2(trans),4(trans)-dienal [FL-no: 05.140] and hexa-2(trans),4(trans)-dienal [FL-no: 05.057]. In addition, new studies on hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] were provided that are evaluated in the present revision of FGE.203, i.e. FGE.203Rev2. Hepta-2,4-dienal [FL-no: 05.084], 2,4-octadienal [FL-no: 05.186] and tr-2,tr-4-nonadienal [FL-no: 05.194] did not induce gene mutations in bacteria. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] did not induce gene mutations in vitro in mammalian cells. Hexa-2(trans),4(trans)-dienal [FL-no: 05.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal [FL-no: 05.057] and deca-2(trans),4(trans)-dienal [FL-no: 05.140] and therefore also for the other substances in this group [FL-no: 02.139, 02.153, 02.162, 02.188, 05.064, 05.071, 05.081, 05.084, 05.101, 05.108, 05.125, 05.127, 05.141, 05.173, 05.186, 05.194, 05.196, 09.573]. These 20 substances can be evaluated using the Procedure for the evaluation of flavouring substances.
KW - a,b-unsaturated aldehydes
KW - straight chain
KW - FGE.203
KW - ,b-unsaturated conjugated double-bonds
KW - FGE.19
KW - subgroup 1.1.4
U2 - 10.2903/j.efsa.2018.5322
DO - 10.2903/j.efsa.2018.5322
M3 - Article
C2 - 32625963
SN - 1831-4732
VL - 16
SP - e05322
JO - EFSA Journal
JF - EFSA Journal
ER -