Following a request from the European Commission, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion to provide scientific advice to the Commission on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.
In Flavouring Group Evaluation 90 (FGE.90), the European Food Safety Authority (EFSA) considered six flavouring substances from a group of flavouring substances consisting of acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances evaluated by JECFA at the 68th meeting. The JECFA has evaluated a group of 15 flavouring substances consisting of aliphatic, acyclic and alicyclic terpenoid tertiary alcohols, and structurally related substances. Two of the JECFA evaluated substances are not in the Register ((±)-ethyl 2-hydroxy-2-methylbutyrate, JECFA no: 1651 and (±)-ethyl 2-hydroxy-3-methylbutyrate, JECFA no: 1652). Seven tertiary alcohols [FL-no: 02.035, 02.037, 02.042, 09.086, 09.227, 09.232 and 09.509] have been considered in FGE.89. Therefore, this consideration only deals with six substances.
This revision of FGE.90 is made because EFSA received new toxicity data on anhydrolinalool oxide [FL-no: 13.097] from FGE.75 which support the evaluation of [FL-no: 13.076 and 13.087] in this FGE.
The Panel concluded that the six substances [FL-no: 02.018, 02.245, 02.250, 02.251, 13.076 and 13.087] are structurally related to the aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters evaluated by EFSA in the Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3).
The Panel agrees with the way the application of the Procedure has been performed by the JECFA for four of the six substances [FL-no: 02.018, 02.245, 02.250 and 02.251]. For the remaining two substances [FL-no: 13.076 and 13.087], no metabolism data are available, neither for the substances themselves nor for related substances. Therefore, in contrast to the JECFA, the Panel cannot conclude that these substances are metabolised to innocuous products and they should accordingly be evaluated via the B-side of the Procedure scheme. The present revision of FGE.90, FGE.90Rev1, includes the consideration of new available toxicity data made available since the publication of FGE.90. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight (bw) was derived from a 90-day study in rats for the structurally related substance anhydrolinalool oxide. Compared with an exposure estimate of 0.12 µg /capita per day for both [FL-no: 13.076 and 13.087], a margin of safety of 26 × 106 can be calculated.
Thus for four substances [FL-no: 02.018, 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 [FL-no: 02.018, 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 [FL-no: 02.018, 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.
Adequate specifications are available for four out of six materials of commerce. For substance [FL-no: 02.251] information on the stereoisomeric composition and for substance [FL-no: 13.087] the identity of the isomers and the stereoisomeric composition needs to be specified.