TY - JOUR
T1 - Flavouring group evaluation 419 (FGE.419)
T2 - 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one
AU - EFSA Panel on Food Additives and Flavourings (FAF)
AU - Younes, Maged
AU - Aquilina, Gabriele
AU - Castle, Laurence
AU - Degen, Gisela
AU - Engel, Karl Heinz
AU - Fowler, Paul J.
AU - Frutos Fernandez, Maria Jose
AU - Fürst, Peter
AU - Gundert-Remy, Ursula
AU - Gürtler, Rainer
AU - Husøy, Trine
AU - Manco, Melania
AU - Moldeus, Peter
AU - Passamonti, Sabina
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wright, Matthew
AU - Benigni, Romualdo
AU - Bolognesi, Claudia
AU - Chipman, Kevin
AU - Cordelli, Eugenia
AU - Nørby, Karin
AU - Svendsen, Camilla
AU - Carfì, Maria
AU - Gagliardi, Gabriele
AU - Martino, Carla
AU - Multari, Salvatore
AU - Mennes, Wim
N1 - Publisher Copyright:
© 2024 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.
PY - 2024
Y1 - 2024
N2 - The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one [FL-no: 16.134] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and is chemically synthesised. In food, it is intended to be used as a flavouring substance only in chewing gum. The chronic dietary exposure to [FL-no: 16.134] was estimated to be 45 μg/person per day for a 60-kg adult and 28.4 μg/person per day for a 15-kg 3-year-old child. [FL-no: 16.134] did not show genotoxicity in a bacterial reverse mutation test and an in vitro mammalian cell micronucleus assay. Based on the submitted toxicokinetic and metabolism data, it can be predicted that the flavouring substance is metabolised to innocuous products only. The Panel derived a lower confidence limit of the benchmark dose (BMDL) of 0.71 mg/kg bw per day for a 20% increase in the relative thyroid (including parathyroid) weight observed in a 90-day toxicity study in rats. Based on this BMDL, adequate margins of exposure of 887 and 374 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL-no: 16.134], when used as a flavouring substance at the estimated level of dietary exposure, based on the intended use and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL-no: 16.134] from its use as a food flavouring substance and from its presence in toothpaste and mouthwash is also not of safety concern.
AB - The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one [FL-no: 16.134] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. The substance has not been reported to occur naturally and is chemically synthesised. In food, it is intended to be used as a flavouring substance only in chewing gum. The chronic dietary exposure to [FL-no: 16.134] was estimated to be 45 μg/person per day for a 60-kg adult and 28.4 μg/person per day for a 15-kg 3-year-old child. [FL-no: 16.134] did not show genotoxicity in a bacterial reverse mutation test and an in vitro mammalian cell micronucleus assay. Based on the submitted toxicokinetic and metabolism data, it can be predicted that the flavouring substance is metabolised to innocuous products only. The Panel derived a lower confidence limit of the benchmark dose (BMDL) of 0.71 mg/kg bw per day for a 20% increase in the relative thyroid (including parathyroid) weight observed in a 90-day toxicity study in rats. Based on this BMDL, adequate margins of exposure of 887 and 374 could be calculated for adults and children, respectively. The Panel concluded that there is no safety concern for [FL-no: 16.134], when used as a flavouring substance at the estimated level of dietary exposure, based on the intended use and use levels as specified in Appendix B. The Panel further concluded that the combined exposure to [FL-no: 16.134] from its use as a food flavouring substance and from its presence in toothpaste and mouthwash is also not of safety concern.
KW - 2-methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one
KW - FGE.419
KW - FL-no: 16.134
U2 - 10.2903/j.efsa.2024.8750
DO - 10.2903/j.efsa.2024.8750
M3 - Journal article
C2 - 38711805
AN - SCOPUS:85192175625
SN - 1831-4732
VL - 22
JO - EFSA Journal
JF - EFSA Journal
IS - 5
M1 - e8750
ER -