Résumé
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (the Panel) is asked to advise 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 is asked to evaluate 13 flavouring substances in the Flavouring Group Evaluation 14, Revision 1 (FGE. 14Rev1), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 13 flavouring substances belong to chemical group 15 and 22, Annex I of the Commission Regulation (EC) No 1565/2000.
The present Flavouring Group Evaluation (FGE) deals with eight phenethyl alcohol derivatives (alcohol, esters and acetals), one phenylacetic acid, one phenethyl aldehyde derivative and three phenylacetals.
Three of the 13 flavouring substances possess a chiral centre and two flavouring substances possess three chiral centres. For two of the substances the stereoisomeric composition has not been specified. The substances have been evaluated irrespective of their chirality. One of the substances can exist as geometrical isomers due to the presence and position of the double bond, but the geometrical isomeric form is given by the name.
Twelve of the 13 flavouring substances are classified into structural class I and one flavouring substance is classified into structural class II according to the decision tree approach presented by Cramer et al. (1978).
Ten of the 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 13 flavouring substances have intakes in Europe from 0.0012 to 33 microgram/capita/day, which are well below the threshold of concern for structural class I of 1800 microgram/person/day and for structural class II of 540 microgram/person/day.
All 13 flavouring substances are expected to be metabolised to innocuous substances.
Overall, the genotoxicity data available are not sufficient to evaluate the genotoxicity adequately. However, the data available on candidate and supporting substances do not give rise to concern with respect to genotoxicity of the 13 candidate substances in this FGE. Consideration was given to ethanol and acetaldehyde, two potential hydrolysis products of the acetals [FL-no: 06.078 and 06.080]. Because of the natural occurrence in food and the endogenous formation in humans of considerably larger amounts of these compounds, their formation from hydrolysis of the acetals was not considered to be of safety concern with respect to genotoxicity at their estimated levels of intakes, based on the MSDI approach.
It was noted that where toxicity data were available they were consistent with the conclusions in the present FGE using the Procedure.
It is considered that on the basis of the default MSDI approach these 13 substances would not give rise to safety concerns at levels of intake arising from their use as flavouring substances.
When the estimated intakes were based on the mTAMDI approach they ranged from 1600 to 5700 microgram/person/day for the 12 flavouring substances from structural class I and for the candidate substance from structural class II the mTAMDI is 3900 microgram/person/day. Thus, the intakes were above the threshold of concern for structural class I of 1800 microgram/person/day and of 560 microgram/person/day for structural class II, except for one candidate substance [FL-no: 05.159] from class I. The one substance [FL-no: 05.159], which has an mTAMDI intake below the threshold of concern for structural class I, is also expected to be metabolised to innocuous products.
Thus, the intakes, estimated on the basis of the mTAMDI, exceed the relevant threshold for the structural class to which the flavouring substance has been assigned for 12 of the 13 flavouring substances considered in this Opinion. Therefore, for these 12 substances [FL-no: 02.166, 06.078, 06.080, 08.108, 09.201, 09.620, 09.684, 09.685, 09.686, 09.756, 09.761 and 09.774] 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 of 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 12 of the 13 candidate substances. Identity test and information on chirality is missing for one substance [FL-no: 09.756]. Information on chirality is also missing for [FL-no: 08.108]. Thus, the final evaluation of the materials of commerce cannot be performed for two of the 13 substances [FL-no: 08.108 and 09.756], pending further information. The remaining 11 substances would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.