Re-evaluation of benzyl alcohol (E 1519) as food additive

Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Peter Fürst; Rainer Gürtler; Ursula Gundert-Remy; Trine Husøy; Wim Mennes; Peter Moldeus; Agneta Oskarsson; Romina Shah; Ine Waalkens-Berendsen; Detlef Wölfle; Polly Boon; Riccardo Crebelli; Alessandro Di Domenico; Metka Filipič; Alicja Mortensen; Henk Van Loveren; Ruud Woutersen; Petra Gergelova; Alessandra Giarola; Federica Lodi; Maria Jose Frutos Fernandez; EFSA Panel on Food Additives and Flavourings (FAF)

doi:10.2903/j.efsa.2019.5876

Re-evaluation of benzyl alcohol (E 1519) as food additive

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Polly Boon, Riccardo Crebelli, Alessandro Di Domenico, Metka Filipič, Alicja MortensenHenk Van Loveren, Ruud Woutersen, Petra Gergelova, Alessandra Giarola, Federica Lodi, Maria Jose Frutos Fernandez, EFSA Panel on Food Additives and Flavourings (FAF)

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Abstract

The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.

Original language	English
Pages	e05876
Number of pages	24
Volume	17
No.	10
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2019.5876
Publication status	Published - Oct 2019

Bibliographical note

Acknowledgements: The Panel wishes to thank: Dimitrios Chrysafidis for the preparatory work on this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

benzyl alcohol
E 1519
food additive
safety
risk assessment
dietary exposure
acceptable daily intake

Access to Document

10.2903/j.efsa.2019.5876Licence: CC BY-ND

Younes_etal_EFSA_Re-evaluation_Of_Benzyl_VoR
© 2019 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 Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 2.47 MBLicence: CC BY-ND

Cite this

Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Fürst, P., Gürtler, R., Gundert-Remy, U., Husøy, T., Mennes, W., Moldeus, P., Oskarsson, A., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Boon, P., Crebelli, R., Di Domenico, A., Filipič, M., ... EFSA Panel on Food Additives and Flavourings (FAF) (2019). Re-evaluation of benzyl alcohol (E 1519) as food additive. EFSA Journal, 17(10), e05876. https://doi.org/10.2903/j.efsa.2019.5876

Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Fürst, P, Gürtler, R, Gundert-Remy, U, Husøy, T, Mennes, W, Moldeus, P, Oskarsson, A, Shah, R, Waalkens-Berendsen, I, Wölfle, D, Boon, P, Crebelli, R, Di Domenico, A, Filipič, M, Mortensen, A, Van Loveren, H, Woutersen, R, Gergelova, P, Giarola, A, Lodi, F, Frutos Fernandez, MJ & EFSA Panel on Food Additives and Flavourings (FAF) 2019, 'Re-evaluation of benzyl alcohol (E 1519) as food additive' EFSA Journal, vol. 17, no. 10, pp. e05876. https://doi.org/10.2903/j.efsa.2019.5876

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abstract = "The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.",

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author = "Maged Younes and Gabriele Aquilina and Laurence Castle and Karl-Heinz Engel and Paul Fowler and Peter F{\"u}rst and Rainer G{\"u}rtler and Ursula Gundert-Remy and Trine Hus{\o}y and Wim Mennes and Peter Moldeus and Agneta Oskarsson and Romina Shah and Ine Waalkens-Berendsen and Detlef W{\"o}lfle and Polly Boon and Riccardo Crebelli and {Di Domenico}, Alessandro and Metka Filipi{\v c} and Alicja Mortensen and {Van Loveren}, Henk and Ruud Woutersen and Petra Gergelova and Alessandra Giarola and Federica Lodi and {Frutos Fernandez}, {Maria Jose} and {EFSA Panel on Food Additives and Flavourings (FAF)}",

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AU - Fowler, Paul

AU - Fürst, Peter

AU - Gürtler, Rainer

AU - Gundert-Remy, Ursula

AU - Husøy, Trine

AU - Mennes, Wim

AU - Moldeus, Peter

AU - Oskarsson, Agneta

AU - Shah, Romina

AU - Waalkens-Berendsen, Ine

AU - Wölfle, Detlef

AU - Boon, Polly

AU - Crebelli, Riccardo

AU - Di Domenico, Alessandro

AU - Filipič, Metka

AU - Mortensen, Alicja

AU - Van Loveren, Henk

AU - Woutersen, Ruud

AU - Gergelova, Petra

AU - Giarola, Alessandra

AU - Lodi, Federica

AU - Frutos Fernandez, Maria Jose

AU - EFSA Panel on Food Additives and Flavourings (FAF)

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N2 - The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.

AB - The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of benzyl alcohol (E 1519) when used as a food additive. The Panel considered that adequate exposure and toxicity data were available. Benzyl alcohol (E 1519) is authorised as a food additive in the EU in accordance with Annex III to Regulation (EC) No 1333/2008. The Panel considered benzyl alcohol of low acute toxicity with no concern with respect to genotoxicity and carcinogenicity and established an acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day based on a no observable adverse effect level (NOAEL) of 400 mg/kg bw per day from the carcinogenicity study in rats. The mean and high exposure estimates in the refined exposure scenarios were maximally 0.27 and 0.81 mg/kg bw per day in toddlers, respectively. The exposure estimates to benzyl alcohol (E 1519) were below the ADI of 4 mg/kg bw per day in all population groups. The Panel noted that also the exposure in the regulatory maximum level exposure assessment scenario is below the ADI in all population groups. The Panel concluded that the exposure to benzyl alcohol (E 1519) does not raise a safety concern at the reported uses and use levels.

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