EFSA Journal (Feb 2018)

Scientific Opinion of Flavouring Group Evaluation 406 (FGE.406): (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one

  • EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF),
  • 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,
  • Holger Zorn,
  • Ulla Beckman Sundh,
  • Romualdo Benigni,
  • Mona‐Lise Binderup,
  • Leon Brimer,
  • Francesca Marcon,
  • Daniel Marzin,
  • Pasquale Mosesso,
  • Gerard Mulder,
  • Agneta Oskarsson,
  • Camilla Svendsen,
  • Jan Van Benthem,
  • Maria Anastassiadou,
  • Maria Carfì,
  • Wim Mennes

DOI
https://doi.org/10.2903/j.efsa.2018.5120
Journal volume & issue
Vol. 16, no. 2
pp. n/a – n/a

Abstract

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Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the safety of the use of the substance (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one [FL‐no: 16.129], as a flavouring substance. The substance is intended to be used in the form of its sodium salt as a flavour modifier in beverages. The Panel concluded that [FL‐no: 16.129] would not raise a concern with respect to genotoxicity under conditions where it remains stable and does not undergo photodegradation. However, the data provided do not rule out genotoxicity for the degradation products. A 90‐day toxicity study with [FL‐no: 16.129] in rats showed no adverse effects at exposure up to 100 mg/kg body weight (bw) per day. No developmental toxicity was observed in rats at dose levels up to 1,000 mg/kg bw per day. An adequate margin of safety was calculated for [FL‐no: 16.129]. The Panel concluded that [FL‐no: 16.129] and its sodium salt are not expected to be of safety concern at the estimated levels of intake. This conclusion applies only to the use of the substance as a flavour modifier at levels up to those specified in beverages, but not to the degradation products that may be formed upon exposure to ultraviolet‐A (UV‐A) light. The conditions protecting [FL‐no: 16.129] from photodegradation have not been adequately investigated. It is also unclear if degradation occurs in the absence of UV light. Based on the data provided, the Panel cannot conclude on the safety of [FL‐no: 16.129] when used as a flavour modifier.

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