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Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 14 flavouring substances assigned to the Flavouring Group Evaluation 80 (FGE.80), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirteen substances have already been considered in FGE.80 and its revision and in FGE.96 [FL‐no: 10.005, 10.024, 10.025, 10.050, 10.061, 10.069, 10.070, 10.072, 10.169, 13.009, 13.012, 13.161 and 16.055]. The remaining flavouring substance 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057] has been cleared with respect to genotoxicity in FGE.217Rev3 and it is considered in this revision 2 of FGE.80. The substance [FL‐no: 10.057] was evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, threshold of toxicological concern (TTC) and available data on metabolism and toxicity. The Panel concluded that [FL‐no: 10.057] does not give rise to safety concerns at its levels of dietary intake, when estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substance, the specifications for the material of commerce have also been considered and the information provided was complete for [FL‐no: 10.057]. However, for the flavouring substance [FL‐no: 10.057] in the present revision and for eight substances evaluated in previous revisions, the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) values are above the TTC for their structural class (III). For four substances previously evaluated in FGE.80Rev1 and in FGE.96, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 13 flavouring substances, data on uses and use levels should be provided to finalise their safety evaluations. For [FL‐no: 10.050, 10.069 and 13.161], information on the composition of stereoisomeric mixtures is needed.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 43 flavouring substances assigned to the Flavouring Group Evaluation 63 (FGE.63), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty‐nine substances have already been considered in FGE.63 and its revisions ([FL‐no: 02.023, 02.099, 02.104, 02.136, 02.155, 02.252, 07.015, 07.069, 07.081, 07.099, 07.100, 07.101, 07.102, 07.114, 07.123, 07.151, 07.190, 07.240, 07.247, 07.249, 07.256, 09.281, 09.282, 09.657, 09.658, 09.923, 09.924, 09.925 and 09.936]). The remaining 14 flavouring substances have been cleared with respect to genotoxicity in FGE.204Rev1 ([FL‐no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.177, 07.188 and 07.244]) and they are considered in this revision 4 of FGE.63. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of these 43 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 43 flavouring substances. However, for 14 of these flavouring substances in the present revision and for 10 of the substances in the previous revision (FGE.63Rev3), the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) values are equal to or above the TTCs for their structural classes (I and II). For 15 substances previously evaluated in FGE.63Rev3, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 39 flavouring substances, more data on uses and use levels should be provided to finalise their safety evaluations.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 55 flavouring substances assigned to the Flavouring Group Evaluation 07 (FGE.07), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Fifty‐three substances have already been considered in FGE.07 and its revisions. This revision 6 includes two additional substances which have been cleared with respect to genotoxicity in FGE.201Rev2 (4‐methyl‐3‐hepten‐5‐one [FL‐no: 07.261]) and FGE.204Rev1 (non‐2‐en‐4‐one, [FL‐no: 07.187]). The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of the 55 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. Normal and maximum use levels were available for all flavouring substances. For 52 substances, including the newly included substances [FL‐no: 07.187 and 07.261], their ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) estimates were above the TTC for their structural classes (I and II). Therefore, for these 52 flavouring substances, more detailed data on uses and use levels should be provided to finalise their safety evaluations.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 35 flavouring substances attributed to the Flavouring Group Evaluation 69 (FGE.69), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirty‐two substances have already been considered in FGE.69 [FL‐no: 02.033, 02.034, 02.036, 02.064, 02.065, 02.080, 07.004, 07.013, 07.022, 07.023, 07.025, 07.026, 07.028, 07.029, 07.032, 07.038, 07.040, 07.042, 07.070, 07.079, 07.086, 07.087, 09.144, 09.178, 09.179, 09.189, 09.200, 09.231, 09.249, 09.476, 09.486 and 09.501]. The remaining three substances [FL‐no: 02.066, 07.024 and 07.027] have been cleared with respect to genotoxicity in FGE.215Rev1 and are considered in this revision FGE.69Rev1. The substances were evaluated through a stepwise approach, namely the Procedure, that integrates information on the structure–activity relationships, intake from current uses, Threshold of Toxicological Concern (TTC) and available data on metabolism and toxicity. The Panel considered that for 33 flavouring substances evaluated through the Procedure the specifications are adequate and the Panel agrees with JECFA conclusions ‘No safety concern at estimated levels of intake as flavouring substances’ when based on the MSDI approach. For two flavouring substances [FL‐no: 07.038 and 07.042], there is insufficient information on their chemical identity to reach a final conclusion. For six substances [FL‐no: 02.066, 07.013, 07.024, 07.028, 07.032 and 07.086], there is no concern when the exposure was estimated based on the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) approach. For 28 substances, use levels are needed to calculate the mTAMDI estimates in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation accordingly. For one substance [FL‐no: 07.027], more reliable data on uses and use levels are required in order to finalise the safety evaluation.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty‐four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL‐no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL‐no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL‐no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL‐no: 12.169] representative for the tertiary monothiols [FL‐no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 49 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL‐no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL‐no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 31 flavouring substances assigned to the Flavouring Group Evaluation 72 (FGE.72), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty‐three substances have already been considered in FGE.72 and FGE.72Rev1 ([FL‐no: 02.011, 02.012, 02.027, 02.029, 02.058, 02.076, 02.109, 05.020, 05.021, 05.124, 05.148, 05.169, 08.036, 08.044, 08.047, 08.055, 08.064, 08.070, 08.079, 09.273, 09.408, 09.931 and 16.001]). The remaining eight flavouring substances have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL‐no: 05.114]) and FGE.201Rev2 ([FL‐no: 02.174, 05.033, 05.090, 05.095, 05.105, 05.107 and 05.126]) and they are considered in this revision 2 of FGE.72. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 31 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for all 31 flavouring substances. For 21 substances, evaluated through the Procedure in the previous revision (FGE.72Rev1), no normal and maximum use levels are available. For four substances, the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are equal to ([FL‐no: 05.090]) or above ([FL‐no: 05.107, 05.105, 05.033]) the TTC for their structural class. Therefore, for these 25 substances more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.71 [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. The remaining 30 substances [FL‐no: 02.020, 02.050, 02.090, 02.112, 02.137, 02.156, 02.210, 05.037, 05.060, 05.070, 05.073, 05.076, 05.078, 05.102, 05.109, 05.150, 05.171, 05.179, 09.276, 09.277, 09.303, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.678 and 09.841] have been cleared with respect to genotoxicity in FGE.200Rev1 and they are considered in this revision. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 39 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL‐no: 08.073 and 09.235]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Normal and maximum use levels should be provided for nine flavouring substances [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. For two flavouring substances [FL‐no: 02.020 and 05.076], the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) estimates are above the TTC for their structural class I. Therefore, additional information on uses and use levels should be provided for these eleven substances in order to finalise their evaluation.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty‐three substances have already been considered in FGE.73 and its four revisions ([FL‐no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL‐no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL‐no: 09.278], the stereoisomeric composition is not specified. For two substances [FL‐no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 12 flavouring substances attributed to the Flavouring Group Evaluation 61 (FGE.61), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.61 and FGE.61Rev1 [FL‐no: 06.001, 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037, 06.081]. The remaining three substances [FL‐no: 06.025, 06.031 and 06.072] have been cleared with respect to genotoxicity in FGE.200Rev1 and are considered in this revision 2 of FGE.61. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 12 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For nine flavouring substances [FL‐no: 06.001, 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037 and 06.081], use levels are still needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) values in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation accordingly.

Abstract The EFSA Panel on Food Additives and Flavourings was requested to evaluate 29 flavouring substances attributed to the Flavouring Group Evaluation 70 (FGE.70), using the Procedure in Commission Regulation (EC) No 1565/2000. Seven substances have already been considered in FGE.70 [FL‐no: 08.085, 09.194, 09.260, 09.300, 09.371, 09.639 and 09.840]. The remaining 22 substances [FL‐no: 02.049, 05.058, 05.111, 05.120, 05.172, 09.947, 02.139, 02.153, 02.162, 02.188, 05.057, 05.064, 05.071, 05.084, 05.101, 05.108, 05.125, 05.127, 05.140, 05.141, 05.173 and 09.573] have been cleared with respect to genotoxicity in FGE.200Rev1 and FGE.203Rev2 and are considered in this revision. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 29 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL‐no: 09.371 and 09.840]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Data on the identity and contents of secondary components should be requested for [FL no: 09.260]. Normal and maximum use levels should be provided for seven flavouring substances [FL‐no: 08.085, 09.194, 09.260, 09.300, 09.371, 09.639 and 09.840]. For six flavouring substances [FL‐no: 05.057, 05.058, 05.111, 05.120, 05.172 and 09.947] further information is required based on the comparison of the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) with the TTCs. This includes more reliable data on use and use levels and then, if required, additional toxicological data.

Abstract 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.

Abstract The Panel on 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 Panel decided 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.

Abstract The EFSA Panel on 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) No 1565/2000. The present consideration concerns a group of four flavouring substances consisting of isopulegone and three other substances evaluated by JECFA at the 55th meeting. This revision is made due to additional toxicity data available for (1R,2S,5R)‐isopulegol [FL‐no: 02.067]. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. p‐Mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with JECFA, the Panel evaluated the candidate substances in this Flavouring Group Evaluation (FGE) via the B‐side of the Procedure. Based on a no observed adverse effect level (NOAEL) from a 90‐day oral toxicity study on [FL‐no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, 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 considered and found adequate. For the three substances evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For [FL‐no: 02.067 and 07.067], the mTAMDI exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the 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 10 tetrahydrofuran derivatives and one furanone derivative evaluated by the JECFA at the 63rd meeting in 2004. This revision is made due to additional toxicity data have become available for anhydrolinalool oxide (5) [FL‐no: 13.097]. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The JECFA concluded all the 11 tetrahydrofuran derivatives at step A3. The Panel agrees with the application of the Procedure as performed by the JECFA for 10 of the 11 substances. For the remaining substance [FL‐no: 13.097] the Panel did not find that it could be metabolised to innocuous products and should accordingly be evaluated via the B‐side of the Procedure scheme. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight was derived from a 90‐day study in rats and compared with an exposure estimate of 0.9 μg/ capita / per day for anhydrolinalool oxide a margin of safety of 3.5 × 106 was calculated. Accordingly, the Panel agrees with the JECFA conclusion ‘No safety concern at estimated level 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 and for all 11 substances, the information is adequate.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 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 (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The present consideration concerns a group of six furanone derivatives evaluated by the JECFA at their 63rd, 65th and 69th meetings. This revision of FGE.99 includes the assessment of the 2,5‐dimethyl‐4‐methoxyfuran‐3(2H)‐one [FL‐no: 13.089] cleared for genotoxicity concern compared to the previous version. The Panel concluded that none of the six substances gives rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach [FL‐nos: 13.010, 13.084, 13.085, 13.089, 13.099 and 13.176]. The specifications of the materials of commerce have also been considered and are adequate for all candidate substances in this FGE. However, for all substances use levels are required to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

Abstract The Panel on 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 (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns 21 aromatic, aliphatic and alicyclic hydrocarbons [FL‐no: 01.002, 01.003, 01.004, 01.005, 01.006, 01.007, 01.008, 01.009, 01.010, 01.016, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] evaluated by the JECFA in 2005. FGE.78Rev1 considered 24 substances, but 4‐methyl‐1,1′‐biphenyl (JECFA‐no: 1334) and biphenyl (JECFA‐no: 1332) [former FL‐no: 01.011 and 01.013] are no longer supported by Industry for use as a flavouring substance in Europe. Moreover 1‐methylnaphthalene [FL‐no: 01.014] is in the process of being deleted from the Union List. This revision is owing to additional genotoxicity data on β‐caryophyllene [FL‐no: 01.007] and 90‐day studies in rats on β‐caryophyllene [FL‐no: 01.007] and myrcene [FL‐no: 01.008]. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The specifications for the materials of commerce are adequate for all substances. The Panel concluded that the 21 aromatic, aliphatic and alicyclic hydrocarbons [FL‐no: 01.002‐01.010, 01.016‐01.020, 01.024, 01.026, 01.029, 01.040, 01.045, 01.061 and 01.077] do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.

The Panel on 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 consideration concerns a group of 30 aliphatic and arylalkyl amines and amides evaluated by JECFA at the 65th meeting in 2005. This revision is required owing to additional available toxicity data on piperine [FL-no: 14.003] and deca-(2E,4E)-dienoic acid isobutyl-amide [FL-no: 16.091]. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological thresholds of concern and available data on metabolism and toxicity. The Panel agrees with JECFA’s conclusion “No safety concern at estimated levels of intake as flavouring substances” based on the Maximised Survey-derived Daily Intake (MSDI) approach for all substances considered in this FGE. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 30 substances, the information is adequate.

The Panel on 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 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 toxicity data have become available for 1-furfurylpyrrole [FL-no: 13.134]. The data are intended to cover the re-evaluation of this substance and 2-acetyl-1-ethylpyrrole [FL-no: 14.045] and 2-acetyl-1-methylpyrrole [FL-no: 14.046]. The Panel concluded that for 6-methylquinoline [FL-no: 14.042], the genotoxicity data available do not clear the concern with respect to genotoxicity in vitro and accordingly the substance is not evaluated through the Procedure. For 21 substances [FL-no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 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 FGE, the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the 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.

The Panel on 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 (the 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 the JECFA (63rd meeting). The revision of this consideration is made since additional toxicity data have become available for isoquinoline [FL-no: 14.001], pyrrole [FL-no: 14.041] and 2-acetylpyrrole [FL-no: 14.047]. The toxicity data on 2-acetylpyrrole should also cover 2-propionylpyrrole [FL-no: 14.068]. Further, additional genotoxicity data on 6-methylquinoline [FL-no: 14.042] have become available. The Panel concluded that for 6-methylquinoline [FL-no: 14.042], the new genotoxicity data did not clear the concern with respect to genotoxicity in vitro and accordingly the substance is not evaluated through the Procedure. For 18 substances [FL-no: 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 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 FGE, the Panel agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. For three substances [FL-no: 13.134, 14.045 and 14.046], additional toxicological data are still required. 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.

The Panel on 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 (the 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 five furanone derivatives evaluated by the JECFA at their 63rd, 65th and 69th meetings. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for one of the five substances [FL-no: 13.010]. Contrary to the JECFA the Panel allocate three substances [FL-no: 13.084, 13.085 and 13.099] to structural class III due to lack of information on natural occurrence. With regards to the substance [FL-no: 13.176] for which the JECFA concluded that the Procedure for the Safety Evaluation of Flavouring Agents could not be applied because of the unresolved toxicological concerns relating to the epoxidation and opening of the furan ring, the Panel concluded that adequate NOAELs exist and accordingly concluded, “No safety concern at the estimated level of intake”. Therefore, the Panel concluded that all five substances do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all five substances, the information is adequate.

The Panel on 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 (the 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 19 aliphatic secondary alcohols, ketones and related esters evaluated by the JECFA at the 59th and 69th meetings in 2002 and 2008. This revision is made due to inclusion of six additional substances, 4,8-dimethyl-3,7-nonadien-2-ol, 6-methylhepta-3,5-dien-2-one, octa-1,5-dien-3-one, (E,E)-3,5-octadien-2-one, (3Z)-4,8-dimethyl-3,7-nonadiene-2-one and 4,8-dimethyl-3,7-nonadien-2-yl acetate [FL-no: 02.252, 07.099, 07.190, 07.247, 07.256 and 09.936] cleared for genotoxicity concern. The substances were evaluated through a stepwise approach that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 19 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.

Abstract The Panel on 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 (the 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 16 alicyclic primary alcohols, aldehydes, acids and related esters evaluated by the JECFA at the 59th meeting in 2002. The revision is made due to consideration of one additional substance compared to the previous version. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 16 substances [FL‐no: 02.114, 02.141, 05.098, 05.104, 05.112, 05.119, 05.123, 08.034, 08.060, 08.067, 09.028, 09.289, 09.488, 09.534, 09.536 and 09.615], considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for all 16 substances, the information is adequate.

Abstract The Panel on 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 (the 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 33 furan‐substituted aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers evaluated by the JECFA. In the present version of FGE.67 eight additional substances have been included. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. For twenty‐two substances [FL‐no: 13.029, 13.030, 13.045, 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.092, 13.101, 13.103, 13.105, 13.106, 13.107, 13.123, 13.138, 13.148, 13.163 and 13.191] a concern for genotoxicity was raised and therefore these were not evaluated using the Procedure. The Panel concluded that 8 substances [FL‐no: 13.006, 13.021, 13.022, 13.023, 13.024, 13.074, 13.116 and 13.190] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. For one substance [FL‐no: 13.058] additional toxicity data are requested. Besides the safety assessment of these substances, the specifications for the materials of commerce have been considered. For three substances [FL‐no: 13.031, 13.045 and 13.047] data on specifications / stereoisomerism are missing.

Abstract The Panel on 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 (the 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 three unsaturated delta‐lactones [FL‐no: 10.031, 10.037 and 10.044] previously evaluated by the JECFA at their 49th meeting in 1997. The JECFA considered that further information on the metabolism of these three substances was required and that they should be evaluated together with other substances containing alpha, beta‐unsaturation and that, therefore, their evaluation should be deferred. However, the EFSA Panel has considered that these three JECFA evaluated aliphatic lactones can be hydrolysed and metabolised to innocuous products in line with the aliphatic lactones evaluated by EFSA in FGE.10Rev2. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all three substances do not give rise to safety concern at their levels of dietary intake, estimated on the basis of the MSDI approach.

Abstract The Panel on 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 (the 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 30 flavouring substances consisting of aliphatic and aromatic ethers evaluated by the JECFA. The substances were evaluated through a stepwise approach that integrates information on structure‐activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for the 30 substances considered in this FGE and agrees with the JECFA conclusion, “No safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for two substances, are information on the composition of stereoisomeric mixture lacking.