Scientific Opinion on Flavouring Group Evaluation 90, Revision 1 (FGE.90Rev1): consideration of six substances evaluated by JECFA (68th meeting) structurally related to aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters evaluated by EFSA in FGE.18Rev1 and FGE.75Rev1

Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA 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 consideration concerns a group of six aliphatic, acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances evaluated by JECFA at the 68th meeting in 2007. This revision of FGE.90 is made because additional toxicity data have become available for a structurally related substance in FGE.75Rev1, anhydrolinalool oxide (5) . The Panel agrees with the application of the Procedure as performed by the JECFA for four substances 02.245, 02.250 and 02.251]. For two substances .076 and 13.087] it could not be concluded that they are metabolised to innocuous substances. Based on the exposure estimates (MSDI) and the no observed adverse effect level (NOAEL) from 90-day toxicity study with anhydrolinalool oxide (5), the Panel considered that the substances [FL-no: 13.076 and 13.087] were not of safety concern at the estimated levels of intake based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. For substance ] information on the stereoisomeric composition has not been specified, and for substance .087], the identity of the isomers needs to be specified. For three substances 13.076 and 13.087] the modified theoretical added maximum daily intake (mTAMDI) is above the threshold of concern and therefore more reliable exposure data are required to perform a more refined exposure estimation and to judge whether a re-evaluation according to the Procedure is needed. Thus for four substances 02.245, 02.250 and 13.076], the Panel agrees with the JECFA conclusion 'no safety concern at estimated level of intake as flavouring substances' based on the MSDI approach.For the six substances, use levels have been provided by the Industry 02.245, 02.250, 02.251, 13.076 and 13.087]. The modified theoretical added maximum daily intake (mTAMDI) figures calculated for three of the six substances 13.076 and 13.087] are above the threshold of concern for their structural classes. For these substances, more reliable exposure data are needed. On the basis of such data, the substances should be reconsidered using the Procedure.