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. 2020 Mar 4;18(3):e06029.
doi: 10.2903/j.efsa.2020.6029. eCollection 2020 Mar.

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

EFSA Panel on Food Additives and Flavourings (FAF); Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Rainer Gürtler, Trine Husøy, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Romualdo Benigni, Claudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Gisela Degen, Daniel Marzin, Camilla Svendsen, Giorgia Vianello, Wim Mennes

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

EFSA Panel on Food Additives and Flavourings (FAF) et al. EFSA J. .

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.

Keywords: FGE.72Rev1; Flavourings; JECFA; α,β‐unsaturated carbonyls and precursors.

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Figures

Figure A.1
Figure A.1
Procedure for the safety evaluation of chemically defined flavouring substances
See this image and copyright information in PMC

References

    1. Cramer GM, Ford RA and Hall RL, 1978. Estimation of toxic hazard – a decision tree approach. Food and Cosmetics Toxicology, 16, 255–276. - PubMed
    1. EFSA CEF Panel (EFSA panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2009. Scientific opinion on Flavouring Group Evaluation 202: 3‐alkylated aliphatic acyclic alpha,beta‐unsaturated aldehydes and precursors with and without additional double‐bonds from chemical subgroup 1.1.3 of FGE.19. EFSA Journal 2009;7(5):1081, 28 pp. 10.2903/j.efsa.2009.1081 - DOI - PMC - PubMed
    1. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2010a. Scientific Opinion on Flavouring Group Evaluation 72 (FGE.72): consideration of aliphatic, branched‐chain saturated and unsaturated alcohols, aldehydes, acids, and related esters evaluated by the JECFA (61st meeting) structurally related to branched‐ and straight‐chain unsaturated carboxylic acids. Esters of these and straight‐chain aliphatic saturated alcohols evaluated by EFSA in FGE.05Rev2 (2010). EFSA Journal 2010;8(10):1402, 41 pp. 10.2903/j.efsa.2010.1402 - DOI
    1. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2010b. Scientific opinion on Flavouring Group Evaluation 5, Revision 2 (FGE.05Rev2): branched‐ and straight‐chain unsaturated carboxylic acids and esters of these with aliphatic saturated alcohols from chemical groups 1, 2, 3 and 5. EFSA Journal 2010;8(10):1400, 84 pp. 10.2903/j.efsa.2010.1400 - DOI
    1. EFSA CEF Panel (EFSA panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013a. Scientific Opinion on Flavouring Group Evaluation 207 (FGE.207): consideration of genotoxic potential for one branched‐chain aliphatic acyclic α,β‐unsaturated 2‐alkylated aldehyde with additional double‐bonds, from subgroup 1.1.2 of FGE.19 and four alicyclic aldehydes with the α,β‐unsaturation in a side‐chain, from subgroup 2.1 of FGE.19, which are considered to be covered by the one substance of subgroup 1.1.2, by EFSA. EFSA Journal 2013;11(5):3228, 17 pp. 10.2903/j.efsa.2013.3228 - DOI

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