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Safety of benzophenone to be used as flavouring
Benzophenone [FL‐no: 07.032] has been evaluated as a flavouring substance, in FGE.69, by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food in 2008. Benzophenone was evaluated also by JECFA (2011) and by IARC (2013) based on studies that were not consid...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010149/ https://www.ncbi.nlm.nih.gov/pubmed/32625332 http://dx.doi.org/10.2903/j.efsa.2017.5013 |
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author | Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Anastassiadou, Maria Carfì, Maria Saarma, Siiri Mennes, Wim |
author_facet | Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Anastassiadou, Maria Carfì, Maria Saarma, Siiri Mennes, Wim |
collection | PubMed |
description | Benzophenone [FL‐no: 07.032] has been evaluated as a flavouring substance, in FGE.69, by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food in 2008. Benzophenone was evaluated also by JECFA (2011) and by IARC (2013) based on studies that were not considered in the EFSA opinion on FGE.69. Therefore, the Commission requested the CEF Panel to carry out a review of existing literature on the safety of this flavouring substance. In the framework of the evaluation of benzophenone as a food contact material, the CEF Panel established a tolerable daily intake (TDI) of 0.03 mg/kg body weight (bw) per day (2009). In the present Opinion, the Panel considered the already existing evaluations by EFSA, JECFA, IARC and available literature data on benzophenone toxicity. Moreover, new data on the use levels of benzophenone as a flavouring substance have been provided. The Panel considers that there is no concern with respect to genotoxicity. The Panel considers the endocrine activities of benzophenone and its metabolite 4‐hydroxybenzophenone as weak and not directly related to the observed toxic effects including the neoplastic effects in rodents. The Panel confirms that the conservative approach taken by EFSA (2009) to derive a TDI of 0.03 mg/kg bw for benzophenone is appropriate to cover the non‐neoplastic effects in the chronic toxicity studies and the neoplastic effects induced in the rodent carcinogenicity studies. The TDI is in the same order of magnitude as the chronic dietary exposure of adults and children to benzophenone (10–20 μg/kg bw per day) for the amount of added flavouring substance. The Panel considers that the calculated TDI and exposure estimate are based on conservative assumptions. The Panel concludes that there is no safety concern for benzophenone under the current condition of use as a flavouring substance. |
format | Online Article Text |
id | pubmed-7010149 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70101492020-07-02 Safety of benzophenone to be used as flavouring Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Anastassiadou, Maria Carfì, Maria Saarma, Siiri Mennes, Wim EFSA J Scientific Opinion Benzophenone [FL‐no: 07.032] has been evaluated as a flavouring substance, in FGE.69, by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food in 2008. Benzophenone was evaluated also by JECFA (2011) and by IARC (2013) based on studies that were not considered in the EFSA opinion on FGE.69. Therefore, the Commission requested the CEF Panel to carry out a review of existing literature on the safety of this flavouring substance. In the framework of the evaluation of benzophenone as a food contact material, the CEF Panel established a tolerable daily intake (TDI) of 0.03 mg/kg body weight (bw) per day (2009). In the present Opinion, the Panel considered the already existing evaluations by EFSA, JECFA, IARC and available literature data on benzophenone toxicity. Moreover, new data on the use levels of benzophenone as a flavouring substance have been provided. The Panel considers that there is no concern with respect to genotoxicity. The Panel considers the endocrine activities of benzophenone and its metabolite 4‐hydroxybenzophenone as weak and not directly related to the observed toxic effects including the neoplastic effects in rodents. The Panel confirms that the conservative approach taken by EFSA (2009) to derive a TDI of 0.03 mg/kg bw for benzophenone is appropriate to cover the non‐neoplastic effects in the chronic toxicity studies and the neoplastic effects induced in the rodent carcinogenicity studies. The TDI is in the same order of magnitude as the chronic dietary exposure of adults and children to benzophenone (10–20 μg/kg bw per day) for the amount of added flavouring substance. The Panel considers that the calculated TDI and exposure estimate are based on conservative assumptions. The Panel concludes that there is no safety concern for benzophenone under the current condition of use as a flavouring substance. John Wiley and Sons Inc. 2017-11-14 /pmc/articles/PMC7010149/ /pubmed/32625332 http://dx.doi.org/10.2903/j.efsa.2017.5013 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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 Silano, Vittorio Bolognesi, Claudia Castle, Laurence Chipman, Kevin Cravedi, Jean‐Pierre Engel, Karl‐Heinz Fowler, Paul Franz, Roland Grob, Konrad Gürtler, Rainer Husøy, Trine Kärenlampi, Sirpa Milana, Maria Rosaria Pfaff, Karla Riviere, Gilles Srinivasan, Jannavi Tavares Poças, Maria de Fátima Tlustos, Christina Wölfle, Detlef Zorn, Holger Benigni, Romualdo Binderup, Mona‐Lise Brimer, Leon Marcon, Francesca Marzin, Daniel Mosesso, Pasquale Mulder, Gerard Oskarsson, Agneta Svendsen, Camilla Anastassiadou, Maria Carfì, Maria Saarma, Siiri Mennes, Wim Safety of benzophenone to be used as flavouring |
title | Safety of benzophenone to be used as flavouring |
title_full | Safety of benzophenone to be used as flavouring |
title_fullStr | Safety of benzophenone to be used as flavouring |
title_full_unstemmed | Safety of benzophenone to be used as flavouring |
title_short | Safety of benzophenone to be used as flavouring |
title_sort | safety of benzophenone to be used as flavouring |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010149/ https://www.ncbi.nlm.nih.gov/pubmed/32625332 http://dx.doi.org/10.2903/j.efsa.2017.5013 |
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