Safety of ethyl acrylate to be used as flavouring

Flavourings and Processing Aids (CEF) EFSA Panel on Food Contact Materials Enzymes, Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Maria Rosaria Milana, Karla Pfaff, Gilles Riviere, Jannavi Srinivasan, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle & 14 others Holger Zorn, Romualdo Benigni, Mona-Lise Binderup, Leon Brimer, Francesca Marcon, Daniel Marzin, Pasquale Mosesso, Gerard Mulder, Agneta Oskarsson, Camilla Svendsen, Maria Anastassiadou, Maria Carfì, Siiri Saarma, Wim Mennes

Research output: Contribution to specialist publicationArticle

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Abstract

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No 178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panel concluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panel has evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 μg/person per day for a 60-kg adult and 2,233 μg/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 μg/person per day. The Panel considered that based on the available data, which covers all relevant genetic endpoints (i.e. gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panel evaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Panel concluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.
Original languageEnglish
Pagese05012
Volume15
No.11
Specialist publicationEFSA Journal
PublisherEuropean Food Safety Authority (EFSA)
DOIs
Publication statusPublished - Nov 2017

Fingerprint

Safety
Food
Papilloma
Chromosome Aberrations
ethyl acrylate
Squamous Cell Carcinoma
Rodentia
Mutation
Enzymes
Genes

Keywords

  • ethyl acrylate
  • [FL-no: 09.037]
  • FGE.71
  • 140-88-5
  • genotoxicity
  • carcinogenicity
  • flavourings

Cite this

EFSA Panel on Food Contact Materials Enzymes, F. A. P. A. CEF., Silano, V., Bolognesi, C., Castle, L., Chipman, K., Cravedi, J-P., ... Mennes, W. (2017). Safety of ethyl acrylate to be used as flavouring. EFSA Journal, 15(11), e05012. https://doi.org/10.2903/j.efsa.2017.5012

Safety of ethyl acrylate to be used as flavouring. / EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF); 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.

In: EFSA Journal, Vol. 15, No. 11, 11.2017, p. e05012.

Research output: Contribution to specialist publicationArticle

EFSA Panel on Food Contact Materials Enzymes, FAPACEF, Silano, V, Bolognesi, C, Castle, L, Chipman, K, Cravedi, J-P, Engel, K-H, Fowler, P, Franz, R, Grob, K, Gürtler, R, Husøy, T, Kärenlampi, S, Milana, MR, Pfaff, K, Riviere, G, Srinivasan, J, Tavares Poças, MDF, Tlustos, C, Wölfle, D, Zorn, H, Benigni, R, Binderup, M-L, Brimer, L, Marcon, F, Marzin, D, Mosesso, P, Mulder, G, Oskarsson, A, Svendsen, C, Anastassiadou, M, Carfì, M, Saarma, S & Mennes, W 2017, 'Safety of ethyl acrylate to be used as flavouring' EFSA Journal, vol. 15, no. 11, pp. e05012. https://doi.org/10.2903/j.efsa.2017.5012
EFSA Panel on Food Contact Materials Enzymes FAPACEF, Silano V, Bolognesi C, Castle L, Chipman K, Cravedi J-P et al. Safety of ethyl acrylate to be used as flavouring. EFSA Journal. 2017 Nov;15(11):e05012. https://doi.org/10.2903/j.efsa.2017.5012
EFSA Panel on Food Contact Materials Enzymes, Flavourings and Processing Aids (CEF) ; 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 ethyl acrylate to be used as flavouring. In: EFSA Journal. 2017 ; Vol. 15, No. 11. pp. e05012.
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AU - Marcon, Francesca

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AU - Svendsen, Camilla

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N2 - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No 178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panel concluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panel has evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 μg/person per day for a 60-kg adult and 2,233 μg/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 μg/person per day. The Panel considered that based on the available data, which covers all relevant genetic endpoints (i.e. gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panel evaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Panel concluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.

AB - The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested by the European Commission according to Art. 29 1(a) of the Regulation (EC) No 178/2002 to carry out a review of existing literature on the safety of ethyl acrylate [FL-no: 09.037] when used as a flavouring substance. Ethyl acrylate [FL-no: 09.037] was evaluated in 2010 by EFSA in FGE.71 as a flavouring substance, based on the 2006 JECFA evaluation. The Panel concluded that ethyl acrylate was of no safety concern at estimated level of intake as flavouring substance based on the Maximised Survey-Derived Daily Intake (MSDI) approach. The Panel has evaluated the new literature available and any previous assessments performed by JECFA (2006) and EFSA (2010). Moreover, new data on the use levels of ethyl acrylate as flavouring substance have been provided. For use as flavouring substance, the chronic dietary exposure estimated using the added portions exposure technique (APET), is calculated to be 3,545 μg/person per day for a 60-kg adult and 2,233 μg/person per day for a 15-kg 3-year-old child. Exposure from food contact materials may be up to 6,000 μg/person per day. The Panel considered that based on the available data, which covers all relevant genetic endpoints (i.e. gene mutations, structural and numerical chromosomal aberrations) there is no concern with respect to genotoxicity of ethyl acrylate. The Panel evaluated the available carcinogenicity studies conducted in rats and mice and agreed with the NTP evaluation (1998) concluding that the forestomach squamous cell papilloma and carcinoma observed in rodents were not relevant to humans. Additionally, there was no evidence of systemic toxicity in short-term and subchronic toxicity studies. Therefore, the Panel concluded that there is no safety concern for the use of ethyl acrylate as a flavouring substance, under the intended conditions of use.

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KW - [FL-no: 09.037]

KW - FGE.71

KW - 140-88-5

KW - genotoxicity

KW - carcinogenicity

KW - flavourings

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SN - 1831-4732

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