TY - GEN
T1 - Scientific Opinion on Flavouring Group Evaluation 72, Revision 2 (FGE.72Rev2)
T2 - consideration of aliphatic, branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters evaluated by JECFA (61st, 68th and 69th meetings) and structurally related to flavouring substances in FGE.05Rev3
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 - Gürtler, Rainer
AU - Husøy, Trine
AU - Moldeus, Peter
AU - Oskarsson, Agneta
AU - Shah, Romina
AU - Waalkens-Berendsen, Ine
AU - Wölfle, Detlef
AU - Benigni, Romualdo
AU - Bolognesi, Claudia
AU - Chipman, Kevin
AU - Cordelli, Eugenia
AU - Degen, Gisela
AU - Marzin, Daniel
AU - Svendsen, Camilla
AU - Vianello, Giorgia
AU - Mennes, Wim
AU - EFSA Panel on Food Additives and Flavourings (FAF)
N1 - Acknowledgments: The Panel wishes to acknowledge the hearing expert: Vibe Meister Beltoft for the support provided to this scientific output.
PY - 2020/3
Y1 - 2020/3
N2 - The EFSA Panel on Food Additives and Flavourings was requested to evaluate 31 flavouring substances assigned to the Flavouring Group Evaluation 72 (FGE.72), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.72 and FGE.72Rev1 ([FL-no: 02.011, 02.012, 02.027, 02.029, 02.058, 02.076, 02.109, 05.020, 05.021, 05.124, 05.148, 05.169, 08.036, 08.044, 08.047, 08.055, 08.064, 08.070, 08.079, 09.273, 09.408, 09.931 and 16.001]). The remaining eight flavouring substances have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL-no: 05.114]) and FGE.201Rev2 ([FL-no: 02.174, 05.033, 05.090, 05.095, 05.105, 05.107 and 05.126]) and they are considered in this revision 2 of FGE.72. 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 these 31 substances gives rise to safety concerns at their levels of dietary intake, 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 for all 31 flavouring substances. For 21 substances, evaluated through the Procedure in the previous revision (FGE.72Rev1), no normal and maximum use levels are available. For four substances, the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are equal to ([FL-no: 05.090]) or above ([FL-no: 05.107, 05.105, 05.033]) the TTC for their structural class. Therefore, for these 25 substances more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.
AB - The EFSA Panel on Food Additives and Flavourings was requested to evaluate 31 flavouring substances assigned to the Flavouring Group Evaluation 72 (FGE.72), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.72 and FGE.72Rev1 ([FL-no: 02.011, 02.012, 02.027, 02.029, 02.058, 02.076, 02.109, 05.020, 05.021, 05.124, 05.148, 05.169, 08.036, 08.044, 08.047, 08.055, 08.064, 08.070, 08.079, 09.273, 09.408, 09.931 and 16.001]). The remaining eight flavouring substances have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL-no: 05.114]) and FGE.201Rev2 ([FL-no: 02.174, 05.033, 05.090, 05.095, 05.105, 05.107 and 05.126]) and they are considered in this revision 2 of FGE.72. 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 these 31 substances gives rise to safety concerns at their levels of dietary intake, 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 for all 31 flavouring substances. For 21 substances, evaluated through the Procedure in the previous revision (FGE.72Rev1), no normal and maximum use levels are available. For four substances, the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are equal to ([FL-no: 05.090]) or above ([FL-no: 05.107, 05.105, 05.033]) the TTC for their structural class. Therefore, for these 25 substances more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.
KW - Flavourings
KW - α
KW - β-unsaturated carbonyls and precursors
KW - FGE.72Rev1
KW - JECFA
U2 - 10.2903/j.efsa.2020.6029
DO - 10.2903/j.efsa.2020.6029
M3 - Article
C2 - 32874247
VL - 18
SP - e06029
JO - EFSA Journal
JF - EFSA Journal
SN - 1831-4732
ER -