Scientific Opinion on Flavouring Group Evaluation 72, Revision 2 (FGE.72Rev2): 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

Flavourings, α,β‐unsaturated carbonyls and precursors, FGE.72Rev1, JECFA
First published in the EFSA Journal
4 marzo 2020
Adopted
28 gennaio 2020
Type
Scientific Opinion

Abstract

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.

Substances
2-Methylbut-2-en-1-ol
Cas: 4675-87-0
Inchi: InChI=1S/C5H10O/c1-3-5(2)4-6/h3,6H,4H2,1-2H3
Iupac: 2-methylbut-2-en-1-ol
2-Ethylhept-2-enal
Cas: 10031-88-6
Inchi: InChI=1S/C9H16O/c1-3-5-6-7-9(4-2)8-10/h7-8H,3-6H2,1-2H3/b9-7+
Iupac: (E)-2-ethylhept-2-enal
2-Methylpent-2-enal
Cas: 623-36-9
Inchi: InChI=1S/C6H10O/c1-3-4-6(2)5-7/h4-5H,3H2,1-2H3/b6-4+
Iupac: (E)-2-methylpent-2-enal
2-Methylcrotonaldehyde
Cas: 497-03-0
Inchi: InChI=1S/C5H8O/c1-3-5(2)4-6/h3-4H,1-2H3/b5-3+
Iupac: (E)-2-methylbut-2-enal
Butylbut-2-enal
Cas: 25409-08-9
Inchi: InChI=1S/C8H14O/c1-3-5-6-8(4-2)7-9/h4,7H,3,5-6H2,1-2H3/b8-4+
Iupac: (2E)-2-ethylidenehexanal
2-Isopropyl-5-methylhex-2-enal
Cas: 35158-25-9
Inchi: InChI=1S/C10H18O/c1-8(2)5-6-10(7-11)9(3)4/h6-9H,5H2,1-4H3/b10-6-
Iupac: (E)-5-methyl-2-propan-2-ylhex-2-enal
2-Methyloct-2-enal
Cas: 49576-57-0
Inchi: InChI=1S/C9H16O/c1-3-4-5-6-7-9(2)8-10/h7-8H,3-6H2,1-2H3/b9-7+
Iupac: (2E)-2-methyloct-2-enal
4-Methylpent-2-enal
Cas: 5362-56-1
Inchi: InChI=1S/C6H10O/c1-6(2)4-3-5-7/h3-6H,1-2H3
Iupac: (2E)-4-methylpent-2-enal

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert‐Remy, Rainer Gürtler, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle and Maged Younes.
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6029
EFSA Journal 2020;18(3):6029
On request from
European Commission