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Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Fumokomp (SF‐009), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003 (in the renewal application the Primar...

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Autores principales: Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Benigni, Romualdo, Boon, Polly, Bolognesi, Claudia, Cordelli, Eugenia, Chipman, Kevin, Sahlin, Ullrika, Carfì, Maria, Carnesecchi, Edoardo, Martino, Carla, Multari, Salvatore, Palaniappan, Vasantha, Tard, Alexandra, Mennes, Wim
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10652694/
https://www.ncbi.nlm.nih.gov/pubmed/38027436
http://dx.doi.org/10.2903/j.efsa.2023.8370
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author Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Degen, Gisela
Engel, Karl‐Heinz
Fowler, Paul J
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wright, Matthew
Benigni, Romualdo
Boon, Polly
Bolognesi, Claudia
Cordelli, Eugenia
Chipman, Kevin
Sahlin, Ullrika
Carfì, Maria
Carnesecchi, Edoardo
Martino, Carla
Multari, Salvatore
Palaniappan, Vasantha
Tard, Alexandra
Mennes, Wim
author_facet Younes, Maged
Aquilina, Gabriele
Castle, Laurence
Degen, Gisela
Engel, Karl‐Heinz
Fowler, Paul J
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wright, Matthew
Benigni, Romualdo
Boon, Polly
Bolognesi, Claudia
Cordelli, Eugenia
Chipman, Kevin
Sahlin, Ullrika
Carfì, Maria
Carnesecchi, Edoardo
Martino, Carla
Multari, Salvatore
Palaniappan, Vasantha
Tard, Alexandra
Mennes, Wim
collection PubMed
description The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Fumokomp (SF‐009), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003 (in the renewal application the Primary Product is reported as ‘Fumokomp Conc.’). This opinion refers to an assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Fumokomp Conc. is produced by pyrolysis of beech and hornbeam woods. Gas chromatography–mass spectrometry (GC–MS) was applied for both identification and quantification of the volatile constituents of the Primary Product. Given the limitations of the method, the Panel cannot judge with confidence whether the applied method meets the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. Moreover, the Panel concluded that the absence of furan‐2(5H)‐one from the Primary Product was not convincingly demonstrated. At the maximum proposed use levels, dietary exposure estimates calculated with FAIM ranged from 0.04 to 0.9 mg/kg body weight (bw) per day at the mean and from 0.1 to 1.5 mg/kg bw per day at the 95th percentile. The information available on the 32 identified components of the Primary Product, although limited, did not indicate a concern for genotoxicity for any of these substances. However, whole mixture testing in an in vitro mouse lymphoma assay gave positive results which would require an adequate in vivo follow‐up study. In addition, the potential for aneugenicity of the Primary Product has not been adequately investigated. Accordingly, the potential safety concern for genotoxicity of the Primary Product cannot be ruled out.
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spelling pubmed-106526942023-11-16 Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product Younes, Maged Aquilina, Gabriele Castle, Laurence Degen, Gisela Engel, Karl‐Heinz Fowler, Paul J Frutos Fernandez, Maria Jose Fürst, Peter Gundert‐Remy, Ursula Gürtler, Rainer Husøy, Trine Manco, Melania Moldeus, Peter Passamonti, Sabina Shah, Romina Waalkens‐Berendsen, Ine Wright, Matthew Benigni, Romualdo Boon, Polly Bolognesi, Claudia Cordelli, Eugenia Chipman, Kevin Sahlin, Ullrika Carfì, Maria Carnesecchi, Edoardo Martino, Carla Multari, Salvatore Palaniappan, Vasantha Tard, Alexandra Mennes, Wim EFSA J Scientific Opinion The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Fumokomp (SF‐009), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003 (in the renewal application the Primary Product is reported as ‘Fumokomp Conc.’). This opinion refers to an assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Fumokomp Conc. is produced by pyrolysis of beech and hornbeam woods. Gas chromatography–mass spectrometry (GC–MS) was applied for both identification and quantification of the volatile constituents of the Primary Product. Given the limitations of the method, the Panel cannot judge with confidence whether the applied method meets the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. Moreover, the Panel concluded that the absence of furan‐2(5H)‐one from the Primary Product was not convincingly demonstrated. At the maximum proposed use levels, dietary exposure estimates calculated with FAIM ranged from 0.04 to 0.9 mg/kg body weight (bw) per day at the mean and from 0.1 to 1.5 mg/kg bw per day at the 95th percentile. The information available on the 32 identified components of the Primary Product, although limited, did not indicate a concern for genotoxicity for any of these substances. However, whole mixture testing in an in vitro mouse lymphoma assay gave positive results which would require an adequate in vivo follow‐up study. In addition, the potential for aneugenicity of the Primary Product has not been adequately investigated. Accordingly, the potential safety concern for genotoxicity of the Primary Product cannot be ruled out. John Wiley and Sons Inc. 2023-11-16 /pmc/articles/PMC10652694/ /pubmed/38027436 http://dx.doi.org/10.2903/j.efsa.2023.8370 Text en © 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH 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
Degen, Gisela
Engel, Karl‐Heinz
Fowler, Paul J
Frutos Fernandez, Maria Jose
Fürst, Peter
Gundert‐Remy, Ursula
Gürtler, Rainer
Husøy, Trine
Manco, Melania
Moldeus, Peter
Passamonti, Sabina
Shah, Romina
Waalkens‐Berendsen, Ine
Wright, Matthew
Benigni, Romualdo
Boon, Polly
Bolognesi, Claudia
Cordelli, Eugenia
Chipman, Kevin
Sahlin, Ullrika
Carfì, Maria
Carnesecchi, Edoardo
Martino, Carla
Multari, Salvatore
Palaniappan, Vasantha
Tard, Alexandra
Mennes, Wim
Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title_full Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title_fullStr Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title_full_unstemmed Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title_short Scientific opinion on the renewal of the authorisation of Fumokomp (SF‐009) as a smoke flavouring Primary Product
title_sort scientific opinion on the renewal of the authorisation of fumokomp (sf‐009) as a smoke flavouring primary product
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10652694/
https://www.ncbi.nlm.nih.gov/pubmed/38027436
http://dx.doi.org/10.2903/j.efsa.2023.8370
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