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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 Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present revision of this FGE is on the assessment of recently submitted toxicity data on methyl propyl trisulfide [FL-no: 12.020], being the representative for a group of seven additional flavouring substances: diallyl trisulfide [FL-no: 12.009], dimethyl trisulfide [FL-no: 12.013], dipropyl trisulfide [FL-no: 12.023], methyl allyl trisulfide [FL-no: 12.045], diallyl polysulfides [FL-no: 12.074], methyl ethyl trisulfide [FL-no: 12.155] and diisopropyl trisulphide [FL-no: 12.280]. Specifications have been provided for all substances. The Paneldecided that the 90-day study submitted for [FL-no: 12.020] can be considered only once it is clearly demonstrated that the material tested is representative of the material of commerce and that potential reaction products of the components are not of safety concern. Therefore, no conclusion on the safety of the eight flavouring substances [FL-no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280] can be reached. For 2-methyl-4-oxopentane-2-thiol [FL-no: 12.169] and 2-mercapto-2-methylpentan-1-ol [FL-no: 12.241], additional subchronic toxicity data are required. The remaining nine substances [FL-no: 12.088, 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291] in this FGE are not considered of safety concern under the intended conditions of use.

International audience; The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 22 pyridine, pyrrole and quinoline derivatives evaluated by JECFA (63rd meeting). The revision of this consideration is made since additional genotoxicity data have become available for 6-methylquinoline [FL-no: 14.042]. The genotoxicity data available rule out the concern with respect to genotoxicity and accordingly the substance is evaluated through the Procedure. For all 22 substances [FL-no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 14.042, 14.045, 14.046, 14.047, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.068, 14.071, 14.072 and 14.164] considered in this Flavouring Group Evaluation (FGE), the Panel agrees with the JECFA conclusion, 'No safety concern at estimated levels of intake as flavouring substances' based on the Maximised Survey-derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been evaluated, and the information is considered adequate for all the substances. For the following substances [FL-no: 13.134, 14.001, 14.030, 14.041, 14.042, 14.058, 14.072], the Industry has submitted use levels for normal and maximum use. For the remaining 15 substances, use levels are needed to calculate the modified Theoretical Added Maximum Daily Intakes (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

International audience; The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested to deliver a scientific opinion on the implication for human health of the product Grillin' CB-200SF [FL-no: 21.004] in the Flavouring Group Evaluation 503, according to Regulation (EC) No 1331/2008 and Regulation (EC) No 1334/2008 of the European Parliament and of the Council. The product is derived from heat-treated high oleic sunflower oil, and intended to be used as a food flavouring with charbroiled or grilled aroma in a wide variety of food categories either in liquid or powder form. Information on manufacturing and compositional data was considered adequate to show the reproducibility of the production process. However, the Panel noted that a substantial amount of the non-volatile fraction of the product could not be identified. The chronic dietary exposure to the substance estimated using the Added Portions Exposure Technique (APET) was calculated to be 60 mg/person per day for a 60-kg adult and 37.8 mg/person per day for a 15-kg child. The data submitted for evaluating the genotoxic potential of the flavouring was considered insufficient. There are still eight substances in the flavouring for which the evaluation of genotoxic potential is pending. No toxicity studies have been provided on the final product itself. Only information on a number of constituents of the flavouring and data on toxicity of several thermally treated fats and oils were provided by the applicant. However, the Panel considered the time-temperature conditions that were applied in the preparation of the substances tested as not comparable to those applied in the course of the production of the flavouring. The Panel concluded that on the basis of the data provided by the applicant the safety of Grillin' CB-200SF cannot be established.

International audience; The Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the flavouring rum ether [FL-no: 21.001] in the Flavouring Group Evaluation 500 (FGE.500), according to Regulation (EC) No1331/2008 and Regulation (EC) No1334/2008 of the European Parliament and of the Council. Rum ether is a complex mixture of volatile substances obtained by distillation of the reaction products of pyroligneous acid and ethyl alcohol under oxidative conditions in the presence of manganese dioxide and sulfuric acid. A total of 84 volatile constituents have been reported by the applicant. It is a colourless liquid with a rum-like odour and flavour. Its major uses are in the food categories beverages, confectionery and baked goods. The Paneldecided to apply a congeneric group-based approach. The 84 reported constituents were allocated to 12 congeneric groups, based on structural and metabolic similarity. For eight of the congeneric groups, the Panelconcluded that there is no safety concern at the intended conditions of use. However, the Panelconcluded that substances in congeneric group 1 (ethanol and acetaldehyde) and congeneric group 12 (furan) are carcinogenic and genotoxic. The Panelalso identified genotoxicity concerns for substances in congeneric group 3 (3-pentene-2-one). The exposure for congeneric group 10 (ethers of various structures) was above the Threshold of Toxicological Concern (TTC) applicable for this group, but a point of departure or health based guidance value that covers all the substances in this group could not be identified. The Panelconcluded that according to the overall strategy for the risk assessment of flavouring substances, the presence of genotoxic substances as process-derived constituents of rum ether is of safety concern.

International audience; The EFSA Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No1565/2000. The present revision of FGE.73 concerns the inclusion of four additional flavouring substances (p-mentha-1,8-dien-7-ol [FL-no: 02.060], myrtenol [FL-no: 02.091], p-mentha-1,8-dien-7-yl acetate [FL-no: 09.278] and myrtenyl acetate [FL-no: 09.302]) evaluated by JECFA at the 59th meeting. The substances were evaluated through a stepwise approach integrating information on structure-activity relationships, intake from current uses, toxicological thresholds of concern (TTC), and available data on metabolism and toxicity. In agreement with JECFA, the Panelevaluated 22 and one candidate substances via the A and the B-side of the Procedure, respectively, and concluded for all substances No safety concern at estimated levels of intake as flavouring substances' based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. Adequate specifications, including complete purity criteria and identity data, are available for 22 out of the 23 JECFA substances evaluated in this FGE. For [FL-no: 09.278], the stereoisomeric composition is not specified. For the six substances with [FL-no: 02.060, 02.091, 09.034, 09.278, 09.302 and 09.712] evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For two substances [FL-no: 09.034, and 09.712], the mTAMDI estimates were above the TTC for their structural class and more detailed information is needed to finalise their evaluation. For the remaining 17 substances evaluated through the Procedure, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment in order to finalise the evaluation.

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.