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.
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.
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.
The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision ...3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al FL‐no: 05.117, which was found to be genotoxic in vivo. The Panel concluded that there was a potential safety concern for the nine substances in this FGE that were all represented by FL‐no: 05.177. Consequently, substance FL‐no: 05.117, as well as four substances (FL‐no: 05.121, 09.272, 09.899 and 09.900), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panel assessed genotoxicity studies submitted on five flavouring substances FL‐no: 02.060, 02.091, 05.106, 09.278 and 09.302 and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal FL‐no: 05.106 for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined in vivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panel concluded that the concern for genotoxicity could be ruled out for myrtenal FL‐no: 05.106. Subsequently, this substance can be evaluated through the Procedure.
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.
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