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International audience; 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

International audience; The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 40,5,7-trihydroxyflavanone or naringenin [FL-no: 16.132], in the Flavouring Group Evaluation 410 (FGE.410), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance occurs naturally in grapefruits, oranges and tomatoes. It is intended to be used as a flavouring substance with flavour-modifying properties in specific categories of food. Information on specifications and manufacturing of [FL-no: 16.132] were considered adequate; however, data on stability in food are incomplete. The Panel noted that the available genotoxicity studies have significant shortcomings and are insufficient to conclude on the genotoxic potential of naringenin. Therefore, [FL-no: 16.132] cannot be evaluated through the Procedure. Additionally, the Panel noted that inhibition of CYP 450 by [FL-no: 16.132] has been clearly demonstrated in animal species in vivo which implies that the substance may interact with the metabolism and elimination of medicines and no convincing information is available that this does not pose a risk to humans at the estimated levels of exposure. To continue with the safety assessment of [FL-no: 16.132], a bacterial gene mutation assay and an in vitro micronucleus assay (according to OECD guidelines 471, 487 and GLP) are required. Even if these studies do not indicate a genotoxic potential, additional toxicological data are needed to finalise the evaluation.