Open AccessSafety of ethyl acrylate to be used as flavouring
Author(s) -
Silano Vittorio,
Bolognesi Claudia,
Castle Laurence,
Chipman Kevin,
Cravedi JeanPierre,
Engel KarlHeinz,
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 MonaLise,
Brimer Leon,
Marcon Francesca,
Marzin Daniel,
Mosesso Pasquale,
Mulder Gerard,
Oskarsson Agneta,
Svendsen Camilla,
Anastassiadou Maria,
Carfì Maria,
Saarma Siiri,
Mennes Wim
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.5012
Subject(s) - genotoxicity , food contact materials , ethyl acrylate , toxicology , food additive , european commission , food science , medicine , food packaging , chemistry , acrylate , european union , biology , organic chemistry , toxicity , business , monomer , economic policy , polymer
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.