Scientific Opinion on Flavouring Group Evaluation 96 (FGE.96): Consideration of 88 flavouring substances considered by EFSA for which EU production volumes / anticipated production volumes have been submitted on request by DG SANCO. Addendum to FGE. 51, 52, 53, 54, 56, 58, 61, 62, 63, 64, 68, 69, 70, 71, 73, 76, 77, 79, 80, 83, 84, 85 and 87.
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000.
The present FGE.96 concerns 88 JECFA-evaluated substances from different FGEs. Common for all the 88 substances was that for none of them European production volumes were available at the time for the first consideration of the FGEs in question. As a consequence, no MSDI could be calculated for EU and accordingly the substances could not be considered by EFSA using the evaluation Procedure. Industry has now provided production volumes for these substances. Based on these newly provided production figures, MSDI values for EU have been calculated and based on these MSDI values the substances have been re-considered by the 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. In the FGEs in question, genotoxicity of the substances considered in FGE.96 has already been addressed. For none of the substances a concern for genotoxicity was identified. The Panel concluded that 87 of the substances do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, for the substance 2-acetyl-1-ethylpyrrole [FL-no: 14.045], the Panel could not identify an appropriate NOAEL and accordingly additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered and for eight stereoisomeric substances [FL-no: 06.040, 08.073, 09.371, 09.780, 10.050, 13.060, 13.161 and 16.039], the stereoisomeric composition has to be specified further.