Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

EFSA Panel on Food Contact Materials

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], 2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278], myrtenyl acetate [FL‐no: 09.302], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL‐no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p‐Mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] and four substances not supported by industry (2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]) have been deleted from the Union List.
Original languageEnglish
Article numbere04766
JournalE F S A Journal
Volume15
Issue number5
Number of pages44
ISSN1831-4732
DOIs
Publication statusPublished - 2017

Keywords

  • FGE.19
  • subgroup 2.2
  • alicyclic aldehydes
  • α,β‐unsaturated

Cite this

@article{6a95efd006a14206b0885b213df44cff,
title = "Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19",
abstract = "The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], 2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278], myrtenyl acetate [FL‐no: 09.302], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL‐no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p‐Mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] and four substances not supported by industry (2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]) have been deleted from the Union List.",
keywords = "FGE.19, subgroup 2.2, alicyclic aldehydes, α,β‐unsaturated",
author = "Beltoft, {Vibe Meister} and N{\o}rby, {Karin Kristiane} and {EFSA Panel on Food Contact Materials}",
year = "2017",
doi = "10.2903/j.efsa.2017.4766",
language = "English",
volume = "15",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
number = "5",

}

TY - JOUR

T1 - Scientific Opinion on Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2): Consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

AU - Beltoft, Vibe Meister

AU - Nørby, Karin Kristiane

AU - EFSA Panel on Food Contact Materials

PY - 2017

Y1 - 2017

N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], 2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278], myrtenyl acetate [FL‐no: 09.302], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL‐no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p‐Mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] and four substances not supported by industry (2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]) have been deleted from the Union List.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], 2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278], myrtenyl acetate [FL‐no: 09.302], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL‐no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p‐Mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] and four substances not supported by industry (2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]) have been deleted from the Union List.

KW - FGE.19

KW - subgroup 2.2

KW - alicyclic aldehydes

KW - α,β‐unsaturated

U2 - 10.2903/j.efsa.2017.4766

DO - 10.2903/j.efsa.2017.4766

M3 - Journal article

VL - 15

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 5

M1 - e04766

ER -