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 evaluate 44 flavouring substances in the Flavouring Group Evaluation 7, Revision 3 (FGE.07Rev3), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 44 flavouring substances belong to chemical group 5, Annex I of the Commission Regulation (EC) No 1565/2000.
The present Flavouring Group Evaluation (FGE) deals with 44 saturated and unsaturated aliphatic secondary alcohols, ketones and esters with a secondary alcohol moiety.
Twenty-two of the 44 candidate substances possess a chiral centre and two of the candidate substances possess two chiral centres.
Due to the presence and the position of double bonds, six of the substances can exist as geometrical isomers. For one of these [FL-no: 07.156], the stereoisomeric composition has been specified as the E/Z mixture, but the composition of the mixture has not been given
Twenty-eight of the flavouring substances have been assigned to structural class I, and 16 substances belong to structural class II.
Forty of the flavouring substances in the present group of 44 flavouring substances have been reported to occur naturally in a wide range of food items.
In its evaluation, the Panel as a default used the Maximised Survey-derived Daily Intake (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European Flavour Industry on the use levels in various foods, it appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the Industry, especially in those cases where the annual production values were reported to be small. In consequence, the Panel had reservations about the data on use and use levels provided and the intake estimates obtained by the MSDI approach.
In the absence of more precise information that would enable the Panel to make a more realistic estimate of the intakes of the flavouring substances, the Panel has decided also to perform an estimate of the daily intakes per person using a modified Theoretical Added Maximum Daily Intake (mTAMDI) approach based on the normal use levels reported by Industry. In those cases where the mTAMDI approach indicated that the intake of a flavouring substance might exceed its corresponding threshold of concern, the Panel decided not to carry out a formal safety assessment using the Procedure. In these cases the Panel requires more precise data on use and use levels.
According to the default MSDI approach, the 44 flavouring substances in this group have intakes in Europe from 0.0012 to 73 microgram/capita/day which are below the threshold of concern value for both structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances.
On the basis of available data from in vitro and in vivo tests on candidate and supporting substances, it can be concluded that the 44 flavouring substances included in this group exhibit no genotoxic potential.
Among the 44 flavouring substances, 43 would be expected to be metabolised to innocuous products at the estimated levels of intake as flavouring substances. The remaining flavouring substance, 5methylheptan-3-one [FL -no: 07.182], may be oxidised to a potential neurotoxic gamma-diketone. However, this metabolic path does not pose a safety concern at the estimated level of intake as a flavouring substance. Indeed, for this substance a No Observed Adverse Effect Level (NOAEL) for neurotoxicity was established, which provided a large margin of safety in relation to the estimated level of intake of the flavouring substance.
Otherwise it was noted, that where toxicity data were available on single flavouring substances, they were consistent with the conclusions in the present Flavouring Group Evaluation (FGE) using the Procedure.
Therefore, it was considered that on the basis of the default MSDI approach none of the 44 flavouring substances would give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances.
When the estimated intakes were based on the mTAMDI they ranged from 1600 to 3900 microgram/person/day for the 28 candidate substances from structural class I. The intakes were all above the threshold of concern for structural class I of 1800 microgram/person/day, except for three flavouring substances [FL-no: 07.084, 07.178 and 07.239]. The estimated intakes of the 16 candidate substances assigned to structural class II, based on the mTAMDI, range from 1500 to 6600 microgram/person/day, which are all above the threshold of concern for structural class II of 540 microgram/person/day. The three substances [FL-no: 07.084, 07.178 and 07.239], which have mTAMDI intake estimates below the threshold of concern for the structural class, are also expected to be metabolised to innocuous products.
Thus, for 41 of the 44 candidate substances considered in this Opinion the intakes, estimated on the basis of the mTAMDI, exceed the relevant threshold for their structural class, to which the flavouring substance has been assigned. Therefore, for these 41 substances more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be reconsidered along the steps of the Procedure. Following this procedure additional toxicological data might become necessary.
In order to determine whether this evaluation could be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including purity and identity for the materials of commerce have been provided for 43 of the 44 flavouring substances. Information on the composition of the stereoisomeric mixture has not been specified for one of the 44 substances [FL-no: 07.156]. Thus, the final evaluation of the materials of commerce cannot be performed for this substance, pending further information.
The remaining 43 substances [FL-no: 02.077, 02.124, 02.142, 02.148, 02.177, 02.182, 02.183, 02.190, 02.255, 07.072, 07.084, 07.150, 07.157, 07.158, 07.160, 07.162, 07.178, 07.181, 07.182, 07.185, 07.189, 07.199, 07.201, 07.205, 07.236, 07.239, 07.262, 09.304, 09.323, 09.325, 09.328, 09.332, 09.386, 09.388, 09.391, 09.604, 09.605, 09.606, 09.608, 09.609, 09.676, 09.880 and 09.926] would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.