Scientific Opinion on Flavouring Group Evaluation 21, Revision 2 (FGE.21Rev2): Thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29. Miscellaneous substances from chemical group 30

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 56 flavouring substances in the Flavouring Group Evaluation 21, Revision 2, using the Procedure in Commission Regulation (EC) No 1565/2000. Seven of the substances 15.086, 15.090, 15.099, 15.114, 15.119 and 15.133] were considered to have genotoxic potential. The remaining 49 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. The Panel concluded that 26 substances 15.039, 15.044, 15.050, 15.051, 15.052, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.080, 15.082, 15.084, 15.085, 15.087, 15.089, 15.098, 15.108, 15.115, 15.116 and 15.118] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining 23 candidate substances 15.040, 15.042, 15.043, 15.045, 15.054, 15.055, 15.064, 15.070, 15.072, 15.074, 15.076, 15.077, 15.088, 15.091, 15.092, 15.093, 15.094, 15.096, 15.097, 15.106, 15.107 and 15.129], of the 49 substances evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the Flavouring Group Evaluation 21, Revision 2 2 EFSA Journal 2011; 9(10):1989 specifications for the materials of commerce have also been considered. For two substances are an identity test lacking and for one has the stereoisomeric composition to be specified. In the present FGE.21Rev2, the 56 candidate substances include five-and six-membered sulphurcontaining aromatic and non-aromatic heterocycles, which have been arranged into 11 subgroups in order to facilitate comparisons of the data sets between the groups. This division was done on the basis of degree of aromaticity and according to the presence of other heteroatoms (i.e. nitrogen).Five of the 56 candidate substances possess one chiral centre Forty-six of the 56 candidate substances are classified into structural class II and 10 candidate substances are classified into structural class III, according to the decision tree approach presented by Cramer et al., 1978. Forty-two of 56 the candidate substances have been reported to occur in a wide range of food items.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. ...

Flavouring Group Evaluation 21 Revision 6 (FGE.21Rev6): thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

“…In revision 2 of FGE.21 (FGE.21Rev2), the same group of 56 substances was considered (EFSA CEF Panel, 2011 ).…”

Scientific Opinion on the safety and efficacy of thiazoles, thiophene, thiazoline and thienyl derivatives (chemical group 29): 3-acetyl-2, 5-dimethylthiophene when used as a flavouring for all animal species

“…(WHO, 2000). Although JECFA concluded that all 12 flavouring substances of CG 29 evaluated were of no safety concern when used at current levels of estimated intake, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) (EFSA, 2008(EFSA, , 2011(EFSA, , 2012(EFSA, , 2013a A consortium of companies (the Feed Flavourings Authorisation Consortium (FFAC)) supplying flavours to the feed industry has requested authorisation for the use of the substance 3-acetyl-2,5-dimethylthiophene of CG 29 (Table 2) as an additive to feed and water for drinking (sensory additives, flavouring compounds) for use in all animal species.…”