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Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2‐hydroxy‐4‐methoxybenzaldehyde [FL‐no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2‐Hydroxy‐4‐methoxybenzaldehyde belongs to chemical group 23 (C...

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Autores principales: Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gürtler, Rainer, Gundert‐Remy, Ursula, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wölfle, Detlef, Wright, Matthew, Benigni, Romualdo, Chipman, Kevin, Cordelli, Eugenia, Degen, Gisela, Carfí, Maria, Vianello, Giorgia, Mennes, Wim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8585641/
https://www.ncbi.nlm.nih.gov/pubmed/34804233
http://dx.doi.org/10.2903/j.efsa.2021.6883
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author Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Carfí, Maria
Vianello, Giorgia
Mennes, Wim
author_facet Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Carfí, Maria
Vianello, Giorgia
Mennes, Wim
collection PubMed
description The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2‐hydroxy‐4‐methoxybenzaldehyde [FL‐no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2‐Hydroxy‐4‐methoxybenzaldehyde belongs to chemical group 23 (Commission Regulation (EC) No 1565/2000) and is structurally related to the hydroxy‐ and alkoxy‐ring substituted benzyl derivatives evaluated in FGE.52 and in FGE.20Rev4. The Panel considered the structural/metabolic similarity sufficient to evaluate the candidate substance following a group‐based approach according to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 05.229] was considered sufficient. From studies carried out with this substance, the Panel concluded that there is no concern with respect to genotoxicity. Based on QSAR evaluation of possible metabolism, and based on information from structurally related substances, various metabolic routes can be anticipated, which only result in the formation of innocuous metabolites. The exposure estimates for [FL‐no: 05.229] (24 and 60 μg/person per day for children and adults, respectively) were below the Threshold of Toxicological Concern (TTC) for its structural class (I). Accordingly, toxicity studies are not required and the Panel concluded at step A3 of the Procedure that 2‐hydroxy‐4‐methoxybenzaldehyde is not of safety concern when used as a flavouring substance at the intended uses and use levels. Cumulative exposure estimates for 2‐hydroxy‐4‐methoxybenzaldehyde and three structurally related substances (2.4 and 6.2 mg/kg body weight (bw) per day for adults and children, respectively) are above the TTC for structural class I, but below the ADI (acceptable daily intake) of 0‐10 mg/kg bw per day for vanillin, which is one of these structurally related substances. Therefore, the cumulative exposure to these four substances [FL‐no: 05.015, 05.018, 05.229 and 09.749] also does not raise a safety concern.
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spelling pubmed-85856412021-11-18 Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde Younes, Maged Aquilina, Gabriele Castle, Laurence Engel, Karl‐Heinz Fowler, Paul Frutos Fernandez, Maria Jose Fürst, Peter Gürtler, Rainer Gundert‐Remy, Ursula Husøy, Trine Manco, Melania Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wölfle, Detlef Wright, Matthew Benigni, Romualdo Chipman, Kevin Cordelli, Eugenia Degen, Gisela Carfí, Maria Vianello, Giorgia Mennes, Wim EFSA J Scientific Opinion The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the substance 2‐hydroxy‐4‐methoxybenzaldehyde [FL‐no: 05.229] as a new flavouring substance, in accordance with Regulation (EC) No 1331/2008. 2‐Hydroxy‐4‐methoxybenzaldehyde belongs to chemical group 23 (Commission Regulation (EC) No 1565/2000) and is structurally related to the hydroxy‐ and alkoxy‐ring substituted benzyl derivatives evaluated in FGE.52 and in FGE.20Rev4. The Panel considered the structural/metabolic similarity sufficient to evaluate the candidate substance following a group‐based approach according to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods. The information provided on the manufacturing process, the composition and the stability of [FL‐no: 05.229] was considered sufficient. From studies carried out with this substance, the Panel concluded that there is no concern with respect to genotoxicity. Based on QSAR evaluation of possible metabolism, and based on information from structurally related substances, various metabolic routes can be anticipated, which only result in the formation of innocuous metabolites. The exposure estimates for [FL‐no: 05.229] (24 and 60 μg/person per day for children and adults, respectively) were below the Threshold of Toxicological Concern (TTC) for its structural class (I). Accordingly, toxicity studies are not required and the Panel concluded at step A3 of the Procedure that 2‐hydroxy‐4‐methoxybenzaldehyde is not of safety concern when used as a flavouring substance at the intended uses and use levels. Cumulative exposure estimates for 2‐hydroxy‐4‐methoxybenzaldehyde and three structurally related substances (2.4 and 6.2 mg/kg body weight (bw) per day for adults and children, respectively) are above the TTC for structural class I, but below the ADI (acceptable daily intake) of 0‐10 mg/kg bw per day for vanillin, which is one of these structurally related substances. Therefore, the cumulative exposure to these four substances [FL‐no: 05.015, 05.018, 05.229 and 09.749] also does not raise a safety concern. John Wiley and Sons Inc. 2021-11-11 /pmc/articles/PMC8585641/ /pubmed/34804233 http://dx.doi.org/10.2903/j.efsa.2021.6883 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Engel, Karl‐Heinz
Fowler, Paul
Frutos Fernandez, Maria Jose
Fürst, Peter
Gürtler, Rainer
Gundert‐Remy, Ursula
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wölfle, Detlef
Wright, Matthew
Benigni, Romualdo
Chipman, Kevin
Cordelli, Eugenia
Degen, Gisela
Carfí, Maria
Vianello, Giorgia
Mennes, Wim
Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title_full Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title_fullStr Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title_full_unstemmed Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title_short Scientific opinion on flavouring group evaluation 414 (FGE.414): 2‐hydroxy‐4‐methoxybenzaldehyde
title_sort scientific opinion on flavouring group evaluation 414 (fge.414): 2‐hydroxy‐4‐methoxybenzaldehyde
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8585641/
https://www.ncbi.nlm.nih.gov/pubmed/34804233
http://dx.doi.org/10.2903/j.efsa.2021.6883
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