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

Vittorio Silano , Claudia Bolognesi , Laurence Castle , Kevin Chipman , Jean Pierre J. P. Cravedi (1) , Karl‐heinz Engel , Paul Fowler , Roland Franz , Konrad Grob , Rainer Gürtler , Trine Husøy , Sirpa Kärenlampi , Maria Rosaria Milana , Karla Pfaff , Gilles Rivière , 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

1 ToxAlim - ToxAlim

The Panelon 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 Panelconcluded 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 100mg/kg body weight (bw) per day. No developmental toxicity was observed in rats at dose levels up to 1,000mg/kg bw per day. An adequate margin of safety was calculated for [FL-no: 16.129]. The Panelconcluded 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 Panelcannot conclude on the safety of [FL-no: 16.129] when used as a flavour modifier

Domaines: Sciences du Vivant [q-bio]

Vittorio Silano, Claudia Bolognesi, Laurence Castle, Kevin Chipman, Jean Pierre J. P. Cravedi, et al.. 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 Journal, 2018, 16 (2), 1 p. ⟨10.2903/j.efsa.2018.5120⟩. ⟨hal-02618062⟩