Panel members at the time of adoption
The CEF Panel of the European Food Safety Authority was requested to evaluate 80 flavouring substances in the Flavouring Group Evaluation 08, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. Since the publication of the last revision of this FGE, the EFSA has been requested to evaluate additional toxicological data submitted for two flavouring substances, one substance 2,5-dihydroxy-2,5-dimethyl-1,4-dithiane [FL-no: 15.006], which support the evaluation of the candidate substance 2,5-dihydroxy-1,4-dithiane [FL-no: 15.134] and one on the candidate substance spiro(2,4-dithia-1-methyl-8-oxabicyclo[3.3.0]octane-3,3’-(1’-oxa-2’-methyl)-cyclopentane) and spiro(2,4-dithia-6-methyl-7-oxabicyclo[3.3.0]octane-3,3’-(1’-oxa-2’-methyl)-cyclopentane) [FL-no: 15.007], which have been included in the present revision of FGE.08. For the substances methyl methanethiosulphonate [FL-no: 12.159], 2-methylbutane-2-thiol [FL-no: 12.172], 2-methylpropane-2-thiol [FL-no: 12.174], ethyl-2-mercapto-2-methyl propanoate [FL-no: 12.304] and 2,4,4-trimethyl-1,3-oxathiane [FL-no: 16.057] there is an indication of a genotoxic potential in vitro. Therefore, without further genotoxicity data, the Panel concluded that the Procedure could not be applied to these five substances. For four substances, 3-mercaptooctanal [FL-no: 12.268], 3-mercaptodecanal [FL-no: 12.269], methanedithiol diacetate [FL-no: 12.271] and 3,5-dimethyl-1,2-dithiolane-4-one [FL-no: 12.295] no data on use as flavouring substances in Europe are available and no intake figures could be calculated, which preclude the evaluation of the four substances using the Procedure. The remaining 71 substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 59 substances do not rise safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For 12 substances [FL-no: 12.093, 12.094, 12.097, 12.100, 12.112, 12.116, 12.120, 12.164, 12.167, 12.199, 15.102 and 15.125], evaluated through the Procedure, no appropriate NOAEL was available and additional data are required. The specifications for the materials of commerce have also been considered and for three substances, information on the specifications is lacking.