Scientific Opinion on Flavouring Group Evaluation 71 Revision 1 (FGE.71Rev1): consideration of aliphatic, linear, α,β‐unsaturated alcohols, aldehydes, carboxylic acids, and related esters evaluated by JECFA (63rd and 69th meeting) structurally related to flavouring substances evaluated in FGE.05Rev3

flavourings, αβ‐unsaturated carbonyls and precursors, FGE.71, JECFA
First published in the EFSA Journal
9 janvier 2020
Adopted
14 novembre 2019
Type
Scientific Opinion

Abstract

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.71 [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. The remaining 30 substances [FL‐no: 02.020, 02.050, 02.090, 02.112, 02.137, 02.156, 02.210, 05.037, 05.060, 05.070, 05.073, 05.076, 05.078, 05.102, 05.109, 05.150, 05.171, 05.179, 09.276, 09.277, 09.303, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.678 and 09.841] have been cleared with respect to genotoxicity in FGE.200Rev1 and they are considered in this revision. 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 39 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, except for [FL‐no: 08.073 and 09.235]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Normal and maximum use levels should be provided for nine flavouring substances [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. For two flavouring substances [FL‐no: 02.020 and 05.076], the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) estimates are above the TTC for their structural class I. Therefore, additional information on uses and use levels should be provided for these eleven substances in order to finalise their evaluation.

Substances
Hex-2-en-1-ol
Cas: 2305-21-7
Inchi: InChI=1S/C6H12O/c1-2-3-4-5-6-7/h4-5,7H,2-3,6H2,1H3
Iupac: (2E)-hex-2-en-1-ol
Pent-2-en-1-ol
Cas: 20273-24-9
Inchi: InChI=1S/C5H10O/c1-2-3-4-5-6/h3-4,6H,2,5H2,1H3/b4-3+
Iupac: (2E)-pent-2-en-1-ol
Non-2(trans)-en-1-ol
Cas: 31502-14-4
Inchi: InChI=1S/C9H18O/c1-2-3-4-5-6-7-8-9-10/h7-8,10H,2-6,9H2,1H3/b8-7+
Iupac: (2E)-non-2-en-1-ol
Non-2(cis)-en-1-ol
Cas: 41453-56-9
Inchi: InChI=1S/C9H18O/c1-2-3-4-5-6-7-8-9-10/h7-8,10H,2-6,9H2,1H3/b8-7-
Iupac: (2Z)-non-2-en-1-ol
Dec-2-en-1-ol
Cas: 22104-80-9
Inchi: InChI=1S/C10H20O/c1-2-3-4-5-6-7-8-9-10-11/h8-9,11H,2-7,10H2,1H3/b9-8+
Iupac: (E)-dec-2-en-1-ol
Hex-2(cis)-en-1-ol
Cas: 928-94-9
Inchi: InChI=1S/C6H12O/c1-2-3-4-5-6-7/h4-5,7H,2-3,6H2,1H3/b5-4-
Iupac: (2Z)-hex-2-en-1-ol
Undec-2-en-1-ol
Cas: 37617-03-1
Inchi: InChI=1S/C11H22O/c1-2-3-4-5-6-7-8-9-10-11-12/h9-10,12H,2-8,11H2,1H3/b10-9+
Iupac: (E)-undec-2-en-1-ol
2-Dodecenal
Cas: 4826-62-4
Inchi: InChI=1S/C12H22O/c1-2-3-4-5-6-7-8-9-10-11-12-13/h10-12H,2-9H2,1H3
Oct-2-enal
Cas: 2363-89-5
Inchi: InChI=1S/C8H14O/c1-2-3-4-5-6-7-8-9/h6-8H,2-5H2,1H3
Iupac: oct-2-enal
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
Hex-2(trans)-enal
Cas: 6728-26-3
Inchi: InChI=1S/C6H10O/c1-2-3-4-5-6-7/h4-6H,2-3H2,1H3/b5-4+
Iupac: (2E)-hex-2-enal
Dec-2-enal
Cas: 3913-71-1
Inchi: InChI=1S/C10H18O/c1-2-3-4-5-6-7-8-9-10-11/h8-10H,2-7H2,1H3/b9-8-
Iupac: dec-2-enal
Tridec-2-enal
Cas: 7774-82-5
Inchi: InChI=1S/C13H24O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14/h11-13H,2-10H2,1H3
Iupac: tridec-2-enal
Pent-2-enal
Cas: 764-39-6
Inchi: InChI=1S/C5H8O/c1-2-3-4-5-6/h3-5H,2H2,1H3
Iupac: (2E)-pent-2-enal
2-Undecenal
Cas: 2463-77-6
Inchi: InChI=1S/C11H20O/c1-2-3-4-5-6-7-8-9-10-11-12/h9-11H,2-8H2,1H3
Hept-2(trans)-enal
Cas: 18829-55-5
Inchi: InChI=1S/C7H12O/c1-2-3-4-5-6-7-8/h5-7H,2-4H2,1H3/b6-5+
Iupac: (2E)-hept-2-enal
Non-2-enal
Cas: 2463-53-8
Inchi: InChI=1S/C9H16O/c1-2-3-4-5-6-7-8-9-10/h7-9H,2-6H2,1H3
Iupac: non-2-enal
Tetradec-2-enal
Cas: 51534-36-2
Inchi: InChI=1S/C14H26O/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15/h12-14H,2-11H2,1H3/b13-12+
Iupac: (2E)-tetradec-2-enal
Oct-2-enyl acetate
Cas: 3913-80-2
Inchi: InChI=1S/C10H18O2/c1-3-4-5-6-7-8-9-12-10(2)11/h7-8H,3-6,9H2,1-2H3/b8-7+
Iupac: (2E)-oct-2-en-1-yl acetate
Oct-2(trans)-enyl butyrate
Cas: 84642-60-4
Inchi: InChI=1S/C12H22O2/c1-3-5-6-7-8-9-11-14-12(13)10-4-2/h8-9H,3-7,10-11H2,1-2H3/b9-8+
Iupac: (2E)-oct-2-en-1-yl butanoate
Hept-2-enyl isovalerate
Cas: 94109-97-4
Inchi: InChI=1S/C12H22O2/c1-4-5-6-7-8-9-14-12(13)10-11(2)3/h7-8,11H,4-6,9-10H2,1-3H3/b8-7+
Iupac: (2E)-hept-2-en-1-yl 3-methylbutanoate
Hept-2-enyl acetate
Cas: 16939-73-4
Inchi: InChI=1S/C9H16O2/c1-3-4-5-6-7-8-11-9(2)10/h6-7H,3-5,8H2,1-2H3/b7-6+
Iupac: (2E)-hept-2-en-1-yl acetate
Hex-2(trans)-enyl acetate
Cas: 2497-18-9
Inchi: InChI=1S/C8H14O2/c1-3-4-5-6-7-10-8(2)9/h5-6H,3-4,7H2,1-2H3/b6-5-
Iupac: [(E)-hex-2-enyl] acetate
Hex-2(trans)-enyl propionate
Cas: 53398-80-4
Inchi: InChI=1S/C9H16O2/c1-3-5-6-7-8-11-9(10)4-2/h6-7H,3-5,8H2,1-2H3/b7-6+
Iupac: (2E)-hex-2-en-1-yl propanoate
Hex-2-enyl butyrate
Cas: 53398-83-7
Inchi: InChI=1S/C10H18O2/c1-3-5-6-7-9-12-10(11)8-4-2/h6-7H,3-5,8-9H2,1-2H3/b7-6+
Iupac: (2E)-hex-2-en-1-yl butanoate
Hex-2-enyl formate
Cas: 53398-78-0
Inchi: InChI=1S/C7H12O2/c1-2-3-4-5-6-9-7-8/h4-5,7H,2-3,6H2,1H3/b5-4+
Iupac: (2E)-hex-2-en-1-yl formate
Hex-2-enyl hexanoate
Cas: 53398-86-0
Inchi: InChI=1S/C12H22O2/c1-3-5-7-9-11-14-12(13)10-8-6-4-2/h7,9H,3-6,8,10-11H2,1-2H3/b9-7+
Iupac: (2E)-hex-2-en-1-yl hexanoate
Hex-2-enyl isovalerate
Cas: 68698-59-9
Inchi: InChI=1S/C11H20O2/c1-4-5-6-7-8-13-11(12)9-10(2)3/h6-7,10H,4-5,8-9H2,1-3H3
Pent-2-enyl hexanoate
Cas: 74298-89-8
Inchi: InChI=1S/C11H20O2/c1-3-5-7-9-11(12)13-10-8-6-4-2/h6,8H,3-5,7,9-10H2,1-2H3/b8-6-
Iupac: (2Z)-pent-2-en-1-yl hexanoate
2-Hexenyl octanoate
Cas: 85554-72-9
Inchi: InChI=1S/C14H26O2/c1-3-5-7-9-10-12-14(15)16-13-11-8-6-4-2/h8,11H,3-7,9-10,12-13H2,1-2H3/b11-8+
Iupac: (2E)-hex-2-en-1-yl octanoate

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, 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.2020.5924
EFSA Journal 2020;18(1):5924
On request from
European Commission