Italia
The Panel on Food additives and Flavourings (FAF) was requested to evaluate the flavouring substances 2,4‐dimethyl‐3‐thiazoline [FL‐no: 15.060] and 2‐isobutyl‐3‐thiazoline [FL‐no: 15.119] in Flavouring Group Evaluation 21 revision 6 (FGE.21Rev6). FGE.21Rev6 deals with 41 flavouring substances of which 39 have been already evaluated to be of no safety concern when based on the MSDI approach. For [FL‐no: 15.060 and 15.119], a concern for genotoxicity was raised in FGE.21. Genotoxicity data have been submitted for the supporting substance 4,5‐dimethyl‐2‐isobutyl‐3‐thiazoline [FL‐no: 15.032] evaluated in FGE.76Rev2. The concerns for gene mutations and clastogenicity are ruled out for [FL‐no: 15.032] and for the structurally related substances [FL‐no: 15.060 and 15.119], but not for aneugenicity. Therefore, the aneugenic potential of [FL‐no: 15.060 and 15.119] should be investigated in studies with the individual substances. For [FL‐no: 15.054, 15.055, 15.057, 15.079 and 15.135], (more reliable) information on uses and use levels is needed to (re)calculate the mTAMDIs in order to finalise their evaluation. Provided that information is submitted for [FL‐no: 15.060 and 15.119] with respect to potential aneugenicity, that would allow evaluation of these substances through the Procedure, also for these two substances, more reliable data on uses and use levels would be required. Upon submission of such data, additional data on toxicity may become necessary for all seven substances. For [FL‐no: 15.054, 15.057, 15.079 and 15.135], information on the actual percentages of stereoisomers in the material of commerce based on analytical data should be provided.
