The European Food Safety Authority (EFSA) asked the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (the Panel) 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 13 flavouring substances in the Flavouring Group Evaluation 15, Revision 2 (FGE.15Rev2), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 13 flavouring substances belong to chemical group 22, Annex I of the Commission Regulation (EC) No 1565/2000.
FGE.15Rev2 includes the assessment of four additional flavouring substances compared to FGE.15Rev1. The present FGE.15Rev2 deals in total with 13 aryl-substituted saturated and unsaturated primary alcohol, aldehyde, acid and ester derivatives belonging to chemical group 22.
Due to the presence and the position of double bonds, seven of the 13 candidate substances can exist as geometrical isomers [FL-no: 05.154, 05.155, 08.088, 08.089, 09.306, 09.339 and 09.735]. For six of these substances [FL-no: 05.155, 08.088, 08.089, 09.306, 09.339 and 09.735] the composition of the geometrical mixture has not been specified sufficiently, as the actual ratio has to be given.
One of the 13 flavouring substances possesses one chiral centre [FL-no: 09.364], which occurs as the racemic mixture.
The 13 flavouring substances are classified into structural class I according to the decision tree approach presented by Cramer et al., 1978.
Ten of the substances in the present group 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 13 flavouring substances in this group have intakes in Europe from 0.0024 to 0.37 microgram/capita/day, which are below the threshold of concern value for structural class I substances of 1800 microgram/person/day.
The genotoxicity data available are not sufficient to evaluate the genotoxicity adequately. However, the limited data available do not preclude evaluation of the 13 flavouring substances, using the Procedure.
The 13 flavouring substances in this flavouring group may be expected to be metabolised to innocuous products.
It was noted that where toxicity data were available they were consistent with the conclusions in the present flavouring group evaluation using the Procedure.
It is considered that on the basis of the default MSDI approach these 13 flavouring substances would not 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 approach they ranged from 1000 to 3900 microgram/person/day for the 13 flavouring substances from structural class I. The intakes were above the threshold of concern for structural class I of 1800 microgram/person/day, except for one flavouring substance [FL-no: 05.155]. This substance is also expected to be metabolised to innocuous products.
Thus, for 12 of the 13 flavouring 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 substances have been assigned. Therefore, for these 12 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 the conclusion for the 13 flavouring substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity tests for the materials of commerce have been provided for seven flavouring substances. For six substances [FL-no: 05.155, 08.088, 08.089, 09.306, 09.339 and 09.735], the composition of the geometrical mixture has to be specified. Thus, the final evaluation of the materials of commerce cannot be performed for these six substances, pending further information.
The remaining seven substances [FL-no: 02.173, 05.154, 05.156, 09.364, 09.690, 09.836 and 09.837] would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.