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Copyright of Food Research & Development is the property of Food Research & Development Editorial Department and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL‐no: 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL‐no: 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL‐no: 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL‐no: 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 10.057]. Consequently, it can be evaluated through the Procedure. [ABSTRACT FROM AUTHOR]

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL‐no: 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL‐no: 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL‐no: 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL‐no: 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 10.057]. Consequently, it can be evaluated through the Procedure.

Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7669/full [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.

The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19, in the Flavouring Group Evaluation 216 (FGE.216). In FGE.216 and in FGE.216Rev1, the CEF Panel requested additional genotoxicity data on 2‐phenylcrotonaldehyde [FL‐no: 05.062], the representative for these five substances. New experimental data on [FL‐no: 05.062] were provided and are evaluated in the present revision of FGE.216 (FGE.216Rev2). Based on the new data, the Panel concluded that, for all the five substances, the concerns for gene mutations and clastogenicity are ruled out by the negative results observed in an in vivo gene mutation assay and in an in vivo comet assay, respectively. In vitro, [FL‐no: 05.062] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus studies were inconclusive and cannot be used to rule out potential aneugenicity of [FL‐no: 05.062] in vivo. Therefore, the Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for this substance. Based on this comparison, the Panel concluded that the use of the flavouring substance [FL‐no: 05.062] at the reported use levels in several food categories would raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances in this FGE [FL‐no: 05.099, 05.100, 05.175 and 05.222], an aneugenic potential may also be anticipated. For these four substances, individual data are needed to establish whether they have aneugenic potential. Accordingly, it is currently not appropriate to assess any of these five substances through the Procedure for the evaluation of flavouring substances. [ABSTRACT FROM AUTHOR]

Abstract The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19, in the Flavouring Group Evaluation 216 (FGE.216). In FGE.216 and in FGE.216Rev1, the CEF Panel requested additional genotoxicity data on 2‐phenylcrotonaldehyde [FL‐no: 05.062], the representative for these five substances. New experimental data on [FL‐no: 05.062] were provided and are evaluated in the present revision of FGE.216 (FGE.216Rev2). Based on the new data, the Panel concluded that, for all the five substances, the concerns for gene mutations and clastogenicity are ruled out by the negative results observed in an in vivo gene mutation assay and in an in vivo comet assay, respectively. In vitro, [FL‐no: 05.062] induced micronuclei through an aneugenic mode of action. The available in vivo micronucleus studies were inconclusive and cannot be used to rule out potential aneugenicity of [FL‐no: 05.062] in vivo. Therefore, the Panel compared the lowest concentration resulting in aneugenicity in vitro with the use levels reported for this substance. Based on this comparison, the Panel concluded that the use of the flavouring substance [FL‐no: 05.062] at the reported use levels in several food categories would raise a concern for aneugenicity. Based on structural similarity, for the remaining four substances in this FGE [FL‐no: 05.099, 05.100, 05.175 and 05.222], an aneugenic potential may also be anticipated. For these four substances, individual data are needed to establish whether they have aneugenic potential. Accordingly, it is currently not appropriate to assess any of these five substances through the Procedure for the evaluation of flavouring substances.

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.024] and 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL‐no: 07.024] and [FL‐no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL‐no: 07.024] and for the structurally related substances 4‐phenylbut‐3‐en‐2‐ol [FL‐no: 02.066] and 3‐methyl‐4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030], the Panel concluded that [FL‐no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow‐up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030] and the structurally related substances vanillylidene acetone [FL‐no: 07.046] and 1‐(4‐methoxyphenyl)‐4‐methylpent‐1‐en‐3‐one [FL‐no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4‐(2,3,6‐trimethylphenyl)but‐3‐en‐2‐one [FL‐no: 07.206] is to be considered as a stand‐alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL‐no: 07.206]. Industry communicated that the evaluation of [FL‐no: 07.206] is not supported any longer, therefore additional data were not submitted.

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL‐no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α‐ionone [FL‐no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α‐damascone [FL‐no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α‐Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α‐damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α‐damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α‐damascone [FL‐no: 07.134] and the four structurally related substances [FL‐no: 07.130, 07.225, 07.226 and 07.231].

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylcoumarin was evaluated using the Procedure in FGE.80Rev1. For 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] and the structurally related substance 3‐hydroxy‐4,5‐dimethylfuran‐2(5H)‐one [FL‐no: 10.030], no further EFSA considerations were needed because these substances were evaluated by JECFA before 2000. Also based on experimental data, in FGE217Rev1, the concern for genotoxicity could not be ruled out for furan‐2(5H)‐one [FL‐no: 10.066] and 3,4‐dimethyl‐5‐pentylidenefuran‐2(5H)‐one [FL‐no: 10.042], which later substance represents the following flavourings: [FL‐no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170]. In the current revision of this FGE (FGE217Rev2), based on the results of additional genotoxicity studies, the FAF Panel concluded that [FL‐no: 10.066] is genotoxic in vivo. Therefore, furan‐2(5H)‐one [FL‐no: 10.066] cannot be evaluated according to the Procedure. For [FL‐no: 10.042] in order to rule out a concern for clastogenicity at site of first contact, the FAF Panel requests results from an in vivo comet assay in duodenum. In addition, [FL‐no: 10.042] has also been identified as an aneugenic substance in vitro. Until the concern for clastogenicity at site of first contact for [FL‐no: 10.042] and the concern for aneugenicity can be ruled out, this substance and [FL‐no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170] cannot be evaluated through the Procedure.

Abstract The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.037] and 2‐nonenal [FL‐no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex‐2(trans)‐enal [FL‐no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058] and oct‐2‐enal [FL‐no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans‐2‐octenal [FL‐no: 05.190], instead of oct‐2‐enal [FL‐no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex‐2(trans)‐enal [FL‐no: 05.073], trans‐2‐octenal [FL‐no: 05.190] and nona‐2(trans),6(cis)‐dienal [FL‐no: 05.058], therefore all the 74 substances [FL‐no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate 53 flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but‐3‐en‐2‐ol, non‐1‐en‐e‐ol, hex‐1‐en‐3‐one and 1‐nonene‐3‐one [FL‐nos: 02.131, 02.187, 07.161 and 07.210] in this Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the 53 substances was considered to have genotoxic potential. 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 all 53 substances do not give 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 50 substances, further information is required based on comparison of the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate 53 flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but-3-en-2-ol, non-1-en-e-ol, hex-1-en-3-one and 1-nonene-3-one [FL-nos: 02.131, 02.187, 07.161 and 07.210] in this Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the 53 substances was considered to have genotoxic potential. 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 all 53 substances do not give 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 50 substances, further information is required based on comparison of the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data. [ABSTRACT FROM AUTHOR]

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested to consider in the Flavouring Group Evaluation 205 (FGE.205), the additional data on genotoxicity submitted by the Industry on two representative substances, oct‐1‐en‐3‐one [FL‐no: 07.081] and pent‐1‐en‐3‐one [FL‐no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent‐1‐en‐3‐one being the most potent (previously available data). In these assays, the representative substances were highly cytotoxic with a steep toxicity curve and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells, the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells. Therefore, the Panel recommended to test the most potent of the representative substances, pent‐1‐en‐3‐one, in an in vivo Comet assay on the first site of contact (e.g. the stomach or duodenum) and on the liver. The Industry has now submitted new data, a combined micronucleus and Comet assay for pent‐1‐en‐3‐one, with scoring in the liver and duodenum, and an Ames test and a Comet assay with scoring in the liver for oct‐1‐en‐3‐one. Based on these new data, the Panel concluded that the concern for a genotoxic potential could be ruled out for the two representative substances and accordingly for the remaining 11 substances in FGE.205Rev1. The 13 substances in FGE.205Rev1 can therefore be evaluated via the Procedure.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in Flavouring Group Evaluation (FGE) 213. In the first version of FGE.213 the Panel concluded, based on available genotoxicity data, that a concern regarding genotoxicity could be ruled out for 11 substances [FL‐nos: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL‐nos: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL‐no: 07.014] and maltyl isobutyrate [FL‐no: 09.525]. In FGE.213Rev2, new data on maltol were considered and the Panel concluded that for maltol [FL‐no: 07.014] and maltyl isobutyrate [FL‐no: 09.525] in food the concern for genotoxicity could be ruled out. Moreover, the Panel reconsidered the available data on p‐mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127], based on new data on the structurally related substance pulegone, and concluded that additional genotoxicity data are needed to rule out the concern for genotoxicity of p‐mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127].

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from FGE.19 subgroup 4.4, in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups: subgroup 4.4a containing [FL‐no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded that for the substances in subgroup 4.4b there is no concern for genotoxicity. In FGE.220, Revision 2, the Panel evaluated genotoxicity studies on two representative substances of subgroup 4.4a: 2,5‐dimethylfuran‐3(2H)‐one [FL‐no:13.119] and 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175]. Based on the submitted data the Panel concluded that 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] does not give rise to concern with respect to genotoxicity. For 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] the concern for genotoxicity could not be ruled out, therefore the Panel requested a repetition of the submitted micronucleus study in the presence of S9‐mix, or a combined in vivo micronucleus and Comet assay, including analysis of the liver. The Flavour Industry has tested again 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] in an in vitro micronucleus assay as was requested by the Panel. This new study is evaluated in FGE.220, Revision 3, where the Panel concluded that [FL‐no: 13.175] does not give rise to concern with respect to genotoxicity and can be evaluated using the Procedure. This is also applicable to other two substances in subgroup 4.4a: 2,5‐dimethyl‐4‐methoxyfuran‐3(2H)‐one [FL‐no:13.089] and 2,5‐dimethyl4‐ethoxyfuran‐3(2H)‐one [FL‐no:13.117]. Based on the available data the substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 22 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212. Based on available genotoxicity data and new genotoxicity data submitted by the Industry, the Panel concluded that genotoxic potential could be ruled out for the six carvone derivatives [FL‐no: 02.062, 07.146, 07.147, 09.143, 09.215 and 09.870], the 11 isophorone derivatives [FL‐no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the five substances [FL‐no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 in FGE.212, FGE.212Rev1 and FGE.212Rev3, respectively. Two substances previously included in FGE.212Rev2, vetiverol and vetiveryl acetate [FL‐no: 02.214 and 09.821], are no longer supported by Industry. Based on the available data, all 22 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure.

The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested to consider in the Flavouring Group Evaluation 205 (FGE.205), the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [ FL-no: 07.081] and pent-1-en-3-one [ FL-no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent-1-en-3-one being the most potent (previously available data). In these assays, the representative substances were highly cytotoxic with a steep toxicity curve and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells, the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells. Therefore, the Panel recommended to test the most potent of the representative substances, pent-1-en-3-one, in an in vivo Comet assay on the first site of contact (e.g. the stomach or duodenum) and on the liver. The Industry has now submitted new data, a combined micronucleus and Comet assay for pent-1-en-3-one, with scoring in the liver and duodenum, and an Ames test and a Comet assay with scoring in the liver for oct-1-en-3-one. Based on these new data, the Panel concluded that the concern for a genotoxic potential could be ruled out for the two representative substances and accordingly for the remaining 11 substances in FGE.205Rev1. The 13 substances in FGE.205Rev1 can therefore be evaluated via the Procedure. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in the Flavouring Group Evaluation 213. In the first version of FGE.213 the Panel concluded based on available genotoxicity data that a concern regarding genotoxicity could be ruled out for [FL-no: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525].

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 24 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212, Revision 2. The Panel concluded in FGE.212, that the genotoxic potential could be ruled out for d-carvone [FL-no: 07.146] together with the structurally related l-carvone [FL-no: 07.147] as well as carveol and the carvyl derivatives [FL-no: 02.062, 09.143, 09.215 and 09.870]. Based on available genotoxicity data and new submitted genotoxicity data from the Industry, the Panel concluded that the genotoxic potential could be ruled out for the 11 isophorone derivatives [FL-no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the two vetiveryl derivatives [FL-no: 02.214 and 09.821] in FGE.212Rev1 and FGE.212Rev2, respectively. For the remaining five substances [FL-no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 there is still a genotoxicity concern and additional data are required.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 13 flavouring substances in Flavouring Group Evaluation 210 (FGE.210) and one additional substance [FL-no: 07.225] in this revision 1 (FGE.210Rev1). In the first version of FGE.210 the Panel concluded that a genotoxic potential could not be ruled out for any of the 13 substances based on data available at that time. The Flavouring Industry has now submitted additional genotoxicity data. The Panel has evaluated these data and concluded that the concern for genotoxic potential is ruled out for eight of the substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170], while for allyl alpha-ionone [FL-no: 07.061] and for alpha-damascone [FL-no: 07.134] and four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] the concern still remains with respect to genotoxicity.

A bstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) of the European Food Safety Authority (EFSA) was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in Flavouring Group Evaluation (FGE) 213. In the first version of FGE.213 the Panel concluded, based on available genotoxicity data, that a concern regarding genotoxicity could be ruled out for 11 substances [FL-nos: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-nos: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525]. In FGE.213Rev2, new data on maltol were considered and the Panel concluded that for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525] in food the concern for genotoxicity could be ruled out. Moreover, the Panel reconsidered the available data on p-mentha-1,4(8)-dien-3-one [FL-no: 07.127], based on new data on the structurally related substance pulegone, and concluded that additional genotoxicity data are needed to rule out the concern for genotoxicity of p-mentha-1,4(8)-dien-3-one [FL-no: 07.127]. [ABSTRACT FROM AUTHOR]

Safety Authority was requested to evaluate the genotoxic potential of 14 flavouring substances in Flavouring Group Evaluation 210 (FGE.210). In FGE.210, the Panel concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210 Revision1, the Panel concluded that the concern for genotoxic potential is ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170] while for allyl a-ionone [FL-no: 07.061], for a-damascone [FL-no: 07.134] and four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] the concern for genotoxicity remains and additional data were requested. The Flavour Industry has submitted additional genotoxicity data for allyl a-ionone [FL-no: 07.061], that are evaluated in the present revision of FGE.210 (Revision 2). Based on these new data the Panel concluded that the genotoxicity concern for allyl a-ionone [FL-no: 07.061] can be ruled out. For a-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] additional genotoxicity data are still required. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 22 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212. Based on available genotoxicity data and new genotoxicity data submitted by the Industry, the Panel concluded that genotoxic potential could be ruled out for the six carvone derivatives [FL-no: 02.062, 07.146, 07.147, 09.143, 09.215 and 09.870], the 11 isophorone derivatives [FL-no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the five substances [FL-no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 in FGE.212, FGE.212Rev1 and FGE.212Rev3, respectively. Two substances previously included in FGE.212Rev2, vetiverol and vetiveryl acetate [FL-no: 02.214 and 09.821], are no longer supported by Industry. Based on the available data, all 22 substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from FGE.19 subgroup 4.4, in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups: subgroup 4.4a containing [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded that for the substances in subgroup 4.4b there is no concern for genotoxicity. In FGE.220, Revision 2, the Panel evaluated genotoxicity studies on two representative substances of subgroup 4.4a: 2,5-dimethylfuran-3(2H)-one [FL-no:13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. Based on the submitted data the Panel concluded that 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] does not give rise to concern with respect to genotoxicity. For 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] the concern for genotoxicity could not be ruled out, therefore the Panel requested a repetition of the submitted micronucleus study in the presence of S9-mix, or a combined in vivo micronucleus and Comet assay, including analysis of the liver. The Flavour Industry has tested again 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] in an in vitro micronucleus assay as was requested by the Panel. This new study is evaluated in FGE.220, Revision 3, where the Panel concluded that [FL-no: 13.175] does not give rise to concern with respect to genotoxicity and can be evaluated using the Procedure. This is also applicable to other two substances in subgroup 4.4a: 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl4-ethoxyfuran-3(2H)-one [FL-no:13.117]. Based on the available data the substances of this FGE are no longer of concern with respect to genotoxicity and can be evaluated through the Procedure. [ABSTRACT FROM AUTHOR]

A straightforward GC–MS method was developed to determine the occurrence of fourteen flavouring compounds in food. It was successfully validated for four generic types of food (liquids, semi-solids, dry solids and fatty solids) in terms of limit of quantification, linearity, selectivity, matrix effects, recovery (53–120%) and repeatability (3–22%). The method was applied to a survey of 61 Dutch food products. The survey was designed to cover all the food commodities for which the EU Regulation 1334/2008 set maximum permitted levels. All samples were compliant with EU legislation. However, the levels of coumarin (0.6–63 mg/kg) may result in an exposure that, in case of children, would exceed the tolerable daily intake (TDI) of 0.1 mg/kg bw/day. In addition to coumarin, estragole, methyl-eugenol, (R)-(+)-pulegone and thujone were EU-regulated substances detected in thirty-one of the products. The non-EU regulated alkenylbenzenes, trans -anethole and myristicin, were commonly present in beverages and in herbs-containing products. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). In FGE.217, 6-methylcoumarin [FL-no: 13.012] was not considered genotoxic and was therefore evaluated through the Procedure in FGE.80Rev1. For the remaining 11 substances, the Panel concluded that based on the data available, a genotoxic potential could not be excluded and accordingly they could not be evaluated through the Procedure. Additional data on genotoxicity for the three representative substances, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023], 3,4-dimethyl-5-pentylidenefuran-2(5H)-one [FL-no: 10.042] and furan-2(5H)-one [FL-no: 10.066], have now been provided. Based on the new data, the Panel concluded that 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [FL-no: 10.023] does not give rise to concern with respect to genotoxicity and can accordingly, together with the structurally related substance, 3-hydroxy-4,5-dimethylfuran-2(5H)-one [FL-no: 10.030] for which it is a representative, be evaluated using the Procedure. For 3,4-dimethyl-5-pentylidenefuran-2(5H)-one [FL-no: 10.042] and furan-2(5H)-one [FL-no: 10.066] the concern for genotoxicity could not be ruled out and a combined micronucleus and Comet assay is requested for these two substances, covering the remaining seven substances [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057 and 10.060].

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19. In the Flavouring Group Evaluation 216 (FGE.216) additional genotoxicity data were requested. Additional genotoxicity studies have now been provided for the representative substance 2-phenylcrotonaldehyde [FL-no: 05.062]. Based on these new data the Panel concluded that the concern for genotoxicity could not be ruled out and requests a proof of sufficient systemic exposure of animals treated with 2-phenylcrotonaldehyde. Moreover, since the substance was genotoxic only without metabolic activation, it appears necessary to prove the absence of genotoxic effect locally in the gastro intestinal system using the Comet assay.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 (FGE.200). The Flavour Industry has provided additional genotoxicity studies for one representative substance in FGE.200, namely hex-2(trans)-enal [FL-no 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [05.037] and 2-nonenal [05.171]. The Panel has evaluated these data and concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and their three representative substances. The Panel confirms, the need for an in vivo Comet assay performed in duodenum and liver for hex-2(trans)-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2(trans),6(cis)-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), a combined in vivo Comet assay and micronucleus assay would be required. For the latter, evidence of bone marrow exposure should be provided. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 26 flavouring substances from subgroup 2.7 of FGE.19 in the Flavouring Group Evaluation 213. In the first version of FGE.213 the Panel concluded based on available genotoxicity data that a concern regarding genotoxicity could be ruled out for [FL-no: 07.047, 07.056, 07.057, 07.075, 07.076, 07.080, 07.117, 07.118, 07.119, 07.120 and 07.168], but for the remaining 15 substances in subgroup 2.7 further genotoxicity data were required. Based on new submitted genotoxicity data, the Panel concluded in FGE.213Rev1 that the concern regarding genotoxicity could be ruled out for 13 substances in subgroup 2.7 [FL-no: 02.106, 07.008, 07.010, 07.041, 07.083, 07.089, 07.108, 07.109, 07.127, 07.136, 07.200, 07.224 and 09.305] but not for maltol [FL-no: 07.014] and maltyl isobutyrate [FL-no: 09.525]. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 13 flavouring substances in Flavouring Group Evaluation 210 (FGE.210) and one additional substance [FL-no: 07.225] in this revision 1 (FGE.210Rev1). In the first version of FGE.210 the Panel concluded that a genotoxic potential could not be ruled out for any of the 13 substances based on data available at that time. The Flavouring Industry has now submitted additional genotoxicity data. The Panel has evaluated these data and concluded that the concern for genotoxic potential is ruled out for eight of the substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170], while for allyl alpha-ionone [FL-no: 07.061] and for alpha-damascone [FL-no: 07.134] and four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231] the concern still remains with respect to genotoxicity [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 24 flavouring substances from subgroup 2.6 of FGE.19 in the Flavouring Group Evaluation 212, Revision 2. The Panel concluded in FGE.212, that the genotoxic potential could be ruled out for d-carvone [FL-no: 07.146] together with the structurally related l-carvone [FL-no: 07.147] as well as carveol and the carvyl derivatives [FL-no: 02.062, 09.143, 09.215 and 09.870]. Based on available genotoxicity data and new submitted genotoxicity data from the Industry, the Panel concluded that the genotoxic potential could be ruled out for the 11 isophorone derivatives [FL-no: 02.083, 02.101, 07.035, 07.098, 07.126, 07.129, 07.172, 07.175, 07.196, 07.202 and 07.255] and the two vetiveryl derivatives [FL-no: 02.214 and 09.821] in FGE.212Rev1 and FGE.212Rev2, respectively. For the remaining five substances [FL-no: 07.033, 07.094, 07.112, 07.140 and 07.219] from subgroup 2.6 there is still a genotoxicity concern and additional data are required. © European Food Safety Authority, 2014 [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider in the Flavouring Group Evaluation 205, the additional data on genotoxicity submitted by the Industry on two representative substances, oct-1-en-3-one [FL-no: 07.081] and pent-1-en-3-one [FL-no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent-1-en-3-one being the most potent (previously available data). In these assays the representative substances were highly cytotoxic with a steep toxicity curve, and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells and the Panel recommend that an in vivo Comet assay on the first site of contact (e.g. the stomach) and on the liver is requested on the most potent of the representative substances, pent-1-en-3-one.

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 10 flavouring substances from subgroup 4.4 of FGE.19 in the Flavouring Group Evaluation 220 (FGE.220). FGE.220 is subdivided into two subgroups (subgroup 4.4a containing [FL-no: 13.089, 13.117, 13.119, 13.157 and 13.175] and subgroup 4.4b containing [13.010, 13.084 and 13.085, 13.099 and 13.176]. For both subgroups the Panel concluded that the genotoxicity alert could not be ruled out based on the data available and accordingly additional genotoxicity data were requested. In FGE.220, Revision 1, the Panel concluded, based on new submitted data, that for the substances in subgroup 4.4b there is no concern for genotoxicity. The Flavour Industry has now provided additional genotoxicity studies for two representative substances of subgroup 4.4a, 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] and 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175]. Based on the new data the Panel concluded that 2,5-dimethylfuran-3(2H)-one [FL-no: 13.119] does not give rise to concern with respect to genotoxicity. For 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no: 13.175] the concern for genotoxicity could not be ruled out and therefore the Panel requests a repetition of the submitted micronucleus study in the presence of S9-mix applying the same conditions and possibly in addition modified conditions, or a combined in vivo micronucleus and Comet assay, including analysis of liver. This is also applicable to 2,5-dimethyl-4-methoxyfuran-3(2H)-one [FL-no:13.089] and 2,5-dimethyl-4-ethoxyfuran-3(2H)-one [FL-no:13.117], which are covered by the representative substance 4-acetyl-2,5-dimethylfuran-3(2H)-one [FL-no:13.175]. The Flavour Industry has informed that 5-methylfuran-3(2H)-one [FL-no: 13.157] is not in common use in the flavour industry and is no longer supported. [ABSTRACT FROM AUTHOR]

Highlights: [•] We present a method to assess dietary exposure to flavouring substances added. [•] This method allows to estimate the dietary exposure by three levels of refinement. [•] The model is illustrated through an example of exposure to isoamyl acetate. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of five flavouring substances from subgroup 3.3 of FGE.19. In the Flavouring Group Evaluation 216 (FGE.216) additional genotoxicity data were requested. Additional genotoxicity studies have now been provided for the representative substance 2‐phenylcrotonaldehyde [FL‐no: 05.062]. Based on these new data the Panel concluded that the concern for genotoxicity could not be ruled out and requests a proof of sufficient systemic exposure of animals treated with 2‐phenylcrotonaldehyde. Moreover, since the substance was genotoxic only without metabolic activation, it appears necessary to prove the absence of genotoxic effect locally in the gastro intestinal system using the Comet assay. [ABSTRACT FROM AUTHOR]

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). In FGE.217, 6‐methylcoumarin [FL‐no: 13.012] was not considered genotoxic and was therefore evaluated through the Procedure in FGE.80Rev1. For the remaining 11 substances, the Panel concluded that based on the data available, a genotoxic potential could not be excluded and accordingly they could not be evaluated through the Procedure. Additional data on genotoxicity for the three representative substances, 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023], 3,4‐dimethyl‐5‐pentylidenefuran‐2(5H)‐one [FL‐no: 10.042] and furan‐2(5H)‐one [FL‐no: 10.066], have now been provided. Based on the new data, the Panel concluded that 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] does not give rise to concern with respect to genotoxicity and can accordingly, together with the structurally related substance, 3‐hydroxy‐4, 5‐dimethylfuran‐2(5H)‐one [FL‐no: 10.030] for which it is a representative, be evaluated using the Procedure. For 3,4‐dimethyl‐5‐pentylidenefuran‐2(5H)‐one [FL‐no: 10.042] and furan‐2(5H)‐one [FL‐no: 10.066] the concern for genotoxicity could not be ruled out and a combined micronucleus and Comet assay is requested for these two substances, covering the remaining seven substances [FL‐no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057 and 10.060]. [ABSTRACT FROM AUTHOR]

Abstract: The Threshold of Toxicological Concern (TTC) is a level of human intake or exposure that is considered to be of negligible risk, despite the absence of chemical-specific toxicity data. The TTC approach is a form of risk characterisation in which uncertainties arising from the use of data on other compounds are balanced against the low level of exposure. The approach was initially developed by the FDA for packaging migrants, and used a single threshold value of 1.5μg/day (called the threshold of regulation). Subsequent analyses of chronic toxicity data resulted in the development of TTC values for three structural classes with different potentials for toxicity (1,800, 540 and 90μg/day). These TTC values have been incorporated into the procedure that is used internationally for the evaluation of flavouring substances. Further developments included additional TTC values for certain structural alerts for genotoxicity (0.15μg/day), and for the presence of an organophosphate group (18μg/day). All of these TTC values were incorporated into an extended decision tree for chemicals, such as contaminants, which might be present in human foods. The TTC approach has been shown to have potential applications to risk assessments of cosmetic ingredients, household products and impurities in therapeutic drugs. [Copyright &y& Elsevier]

Abstract: Realistic estimates of intake are essential for risk assessments of flavouring agents, since substantial over or underestimations introduce inaccuracies into such evaluations. The objectives of this study were to examine the relationship between intakes estimated using methods based on the reported volume of production [e.g., maximized survey-derived daily intake (MSDI)] versus use-level data [e.g., possible average daily intake (PADI) and modified theoretical added maximum daily intake (mTAMDI)]. The impact of volatility, self-limiting organoleptic properties and whether 10% of the population are eaters, an assumption in the MSDI calculation, on intake estimates were investigated. Analyses on 221 flavouring substances showed that intake estimates derived from MSDI correlated with values determined from detailed 14-day menu-census data, PADI, and mTAMDI. Comparisons of menu-census intake data adjusted to account for factors such as volatile losses showed that MSDI estimates are realistic and sufficiently conservative, whereas mTAMDI results in substantial overestimates of intake. Very few flavours have less than 10% eaters, and in the worst case, this assumption underestimates percent eaters by a factor of about 4. This investigation supports the use of MSDI as a conservative yet practical method to estimate intake of flavouring substances. [Copyright &y& Elsevier]

Abstract: This study was conducted to determine the margins of safety between no-observed-effect levels (NOELs) and estimates of daily intake for 809 flavouring substances evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) between 2000 and 2004. Estimates of daily intake were calculated using two methods, the maximized survey-derived daily intake (MSDI) and the possible average daily intake (PADI). The MSDI estimates were based on the production volume of flavouring agents as reported by industry, whereas the higher more conservative PADI estimates were derived by multiplying the anticipated average use level of a flavouring substance in each of 33 food categories by the average amount of food consumed daily from that food category and summing the intake over all 33 food categories. These intake estimates were used to calculate the margins of safety for the flavouring agents to determine whether adequate margins of safety would still exist in the event that the MSDIs used by JECFA to evaluate the safety of flavouring substances underestimated daily intakes. Based on the calculation of the margins of safety using the MSDI values, 99.9% of the 809 flavouring substances evaluated by JECFA have margins of safety of greater than 100. In comparison, 98% of flavouring substances have margins of safety of greater than 100 when the margins of safety were calculated from PADI values. The results indicate that if the MSDI estimates used by JECFA for the evaluation of the safety of flavouring substances were underestimated, a wide margin of safety exists for all but a few of the flavouring substances even when intakes were estimated from PADI values. [Copyright &y& Elsevier]