TY - JOUR
T1 - Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6)
T2 - saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5
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 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 - Wölfle, Detlef
AU - Wright, Matthew
AU - Benigni, Romualdo
AU - Bolognesi, Claudia
AU - Chipman, Kevin
AU - Cordelli, Eugenia
AU - Degen, Gisela
AU - Marzin, Daniel
AU - Nørby, Karin Kristiane
AU - Svendsen, Camilla
AU - Vianello, Giorgia
AU - Mennes, Wim
N1 - Publisher Copyright:
© 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
PY - 2022/2
Y1 - 2022/2
N2 - 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.
AB - 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.
KW - FGE.63
KW - Flavourings
KW - JECFA
KW - α,β-unsaturated carbonyls and precursors
UR - http://www.scopus.com/inward/record.url?scp=85127027806&partnerID=8YFLogxK
U2 - 10.2903/j.efsa.2022.7090
DO - 10.2903/j.efsa.2022.7090
M3 - Article
AN - SCOPUS:85127027806
SN - 1831-4732
VL - 20
JO - EFSA Journal
JF - EFSA Journal
IS - 2
M1 - e07090
ER -