Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19
Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings a...
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| Language: | English |
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Wiley
2019-05-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2019.5676 |
| _version_ | 1818598613343797248 |
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| author | 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 Maria Carfì Giorgia Vianello Wim Mennes |
| author_facet | 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 Maria Carfì Giorgia Vianello Wim Mennes |
| author_sort | EFSA Panel on Food Additives and Flavourings (FAF) |
| collection | DOAJ |
| description | Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL‐no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α‐ionone [FL‐no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α‐damascone [FL‐no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α‐Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α‐damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α‐damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α‐damascone [FL‐no: 07.134] and the four structurally related substances [FL‐no: 07.130, 07.225, 07.226 and 07.231]. |
| first_indexed | 2024-12-16T12:06:29Z |
| format | Article |
| id | doaj.art-5bfdce2cbdd54e13b8751c7780e9dd37 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-16T12:06:29Z |
| publishDate | 2019-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-5bfdce2cbdd54e13b8751c7780e9dd372022-12-21T22:32:18ZengWileyEFSA Journal1831-47322019-05-01175n/an/a10.2903/j.efsa.2019.5676Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19EFSA Panel on Food Additives and Flavourings (FAF)Maged YounesGabriele AquilinaLaurence CastleKarl‐Heinz EngelPaul FowlerMaria Jose Frutos FernandezPeter FürstUrsula Gundert‐RemyRainer GürtlerTrine HusøyPeter MoldeusAgneta OskarssonRomina ShahIne Waalkens‐BerendsenDetlef WölfleRomualdo BenigniClaudia BolognesiKevin ChipmanEugenia CordelliGisela DegenDaniel MarzinCamilla SvendsenMaria CarfìGiorgia VianelloWim MennesAbstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL‐no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α‐ionone [FL‐no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α‐damascone [FL‐no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α‐Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α‐damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α‐damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α‐damascone [FL‐no: 07.134] and the four structurally related substances [FL‐no: 07.130, 07.225, 07.226 and 07.231].https://doi.org/10.2903/j.efsa.2019.5676α,β‐unsaturated alicyclic ketonesflavouring substancessafety evaluationFGE.210subgroup 2.4FGE.19 |
| spellingShingle | 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 Maria Carfì Giorgia Vianello Wim Mennes Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 EFSA Journal α,β‐unsaturated alicyclic ketones flavouring substances safety evaluation FGE.210 subgroup 2.4 FGE.19 |
| title | Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 |
| title_full | Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 |
| title_fullStr | Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 |
| title_full_unstemmed | Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 |
| title_short | Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β‐unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19 |
| title_sort | scientific opinion on flavouring group evaluation 210 revision 3 fge 210rev3 consideration of genotoxic potential for α β unsaturated alicyclic ketones and precursors from chemical subgroup 2 4 of fge 19 |
| topic | α,β‐unsaturated alicyclic ketones flavouring substances safety evaluation FGE.210 subgroup 2.4 FGE.19 |
| url | https://doi.org/10.2903/j.efsa.2019.5676 |
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