Résumé
The Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) was asked 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.
The JECFA has at their 68th meeting 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-methylvalerate, JECFA no: 1652). Seven tertiary alcohols and esters of these [FL-no: 02.035, 02.037, 02.042, 09.086, 09.227, 09.232 and 09.509] have been considered in FGE.89. This consideration therefore only deals with six substances.
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 the European Food Safety Authority (EFSA) in the Flavouring Group Evaluation 18, Revision 1 (FGE.18Rev1).
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. A No Observed Adverse Effect Level (NOAEL) could not be identified for these two substances or for structurally related substances and accordingly, additional data are required.
For five of the six substances, use levels have been provided by the Industry [FL-no: 02.018, 02.250, 02.251, 13.076 and 13.087]. The mTAMDI figures calculated for three of the five 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. For the one remaining substance [FL-no: 02.245] use levels are needed to calculate the mTAMDI in order to identify if a more refined exposure assessment is needed to finalise the evaluation.
In order to determine whether the conclusion for the six JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications are available for one [FL-no: 02.018] of the six materials of commerce. For two substances [FL-no: 02.250 and 02.251] information on the stereoisomeric composition has not been specified and an ID test is missing. Data on solubility in ethanol is lacking for three substances [FL-no: 02.245, 13.076 and 13.087] and in water for one substance [FL-no: 02.245].
Thus, for two substances [FL-no: 02.250 and 02.251] the Panel has reservations (missing information on stereoisomerism and missing ID test). For two substances [FL-no: 13.076 and 13.087] the Panel concluded that additional data are needed before they can be evaluated as a flavouring substance.
For the remaining two substances [FL-no: 02.018 and 02.245] the Panel agrees with the JECFA conclusion "No safety concern at estimated level of intake as flavouring substances" based on the MSDI approach.