Résumé
The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food 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 Scientific Panel is asked to evaluate the 21 flavouring substances in this Flavouring Group 1 Evaluation, Revision 1 (FGE. 01Rev1), using the procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 21 flavouring substances belong to chemical groups 1 and 2, Annex I of the Commission Regulation (EC) No 1565/2000.
The present Flavouring Group Evaluation deals with 21 branched-chain aliphatic acyclic saturated aldehydes, carboxylic acids and esters derived from aliphatic acyclic primary saturated alcohols and branched-chain aliphatic acyclic saturated carboxylic acids. Fifteen of the flavouring substances possess a chiral centre. In three of these cases, the substance has been presented without indication whether the commercial flavouring substance was dominated by one of the chiral isomers.
All 21 flavouring substances are classified into structural class I.
Thirteen of the flavouring 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 Intakes(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 Flavouring 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 21 flavouring substances in this group have intakes in Europe from 0.0012 to 9.0 microgram/capita/day, which are below the threshold of concern value for structural class I substances of 1800 microgram/person/day.
Genotoxicity data are only available for one structurally related substance and the genotoxicity could therefore not be assessed adequately for the substances in the present group. However, the data available do not preclude evaluation of the flavouring substances in the present group using the Procedure. All 21 flavouring substances in the present flavouring group are 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 FGE using the Procedure.
On the basis of the default MSDI approach the Panel concluded that these 21 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 3500 microgram/person/day for 20 flavouring substances from structural class I. For one of the flavouring substances use levels were lacking and the mTAMDI could not be calculated. Except for six flavouring substances the intakes were above the threshold of concern for a structural class I substance of 1800 microgram/person/day. The six substances which have mTAMDI intake estimates below the threshold of concern for structural class I, are also expected to be metabolised to innocuous products.
Thus, for 14 of the 21 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 substance has been assigned. Therefore, for these 14 substances, as well as for the one substance [FL-no: 05.219], for which use levels are missing, 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 complete purity criteria and identity tests for the materials of commerce have been provided for 19 of the 21 flavouring candidate substances, except that information on geometrical isomerism/chirality is missing for three of the substances [FL-no: 05.160, 05.211 and 05.219]. For two substances [FL-no: 09.418 and 09.585] the purity criteria are deficient in one of the parameters.
Thus, the final evaluation of the materials of commerce cannot be performed for five substances [FL-no: 05.160, 05.211, 05.219, 09.418 and 09.585], pending further information. The remaining 16 substances [FL-no: 05.164, 05.166, 05.167, 05.169, 08.094, 08.095, 08.096, 08.097, 08.115, 09.387, 09.392, 09.499, 09.663, 09.679, 09.698 and 09.839] would present no safety concern at the levels of intake estimated on the basis of the MSDI approach.