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Scientific Opinion on Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 45 flavouring substances in the Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4), using the Procedure in Commission Regulation (EC) No 1565/2000. This revision 4 is made due to inclusion of four additional substances, o-, m- and p-tolualdehyde [FL no: 05.026, 05.028 and 05.029] and phenylmethyl 2-methyl-2-butenoate [FL no: 09.858]. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that all the substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for all 45 candidate substances.
© European Food Safety Authority, 2012
The European Food Safety Authority (EFSA) asked the Scientific 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 45 flavouring substances in the Flavouring Group Evaluation 20, Revision 4 (FGE.20Rev4), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These flavouring substances belong to chemical groups 23 and 30, Annex I of the Commission Regulation (EC) No 1565/2000.
The present revision of FGE.20, FGE.20Rev4, includes the evaluation of four additional substances, o- m- and p-tolualdehyde [FL no: 05.026, 05.028 and 05.029] and phenylmethyl 2-methyl-2-butenoate [09.858].
Four flavouring substances can exist as optical isomers [FL-no: 06.104, 09.313, 09.317 and 09.852] and four substances can exist as geometrical isomers [FL-no: 09.314, 09.560, 09.570 and 09.858].
Forty-one candidate substances are classified into structural class I and four [FL-no: 02.205, 05.066, 05.221 and 06.104] are classified into structural class II according to the decision tree approach presented by Cramer et al., 1978.
Twenty-five 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 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 41 flavouring substances allocated to structural class I have intakes in Europe from 0.001 to 610 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day). The four substances in structural class II [FL-no: 02.205, 05.066, 05.221 and 06.104] have estimated intakes of 0.011, 1.2, 0.61 and 100 microgram/capita/day, respectively. These intakes are below the threshold values of 540 microgram/person/day for structural class II.
On the basis of the reported annual production in Europe (MSDI approach), the combined intake of the 41 of the candidate substances belonging to structural class I is approximately 1400 microgram/capita/day and the combined intake of the four candidate substances belonging to structural class II is approximately 100 microgram/capita/day. These values are lower than the threshold of concern for structural class I and II substances. Based on reported production volumes, European per capita intakes (MSDI) could be estimated for 76 of the 77 supporting substances. The total combined intakes of the candidate and supporting substances are approximately 75000 and 7100 microgram/capita/day for structural class I and II, respectively, which exceed the thresholds of concern. However, the substances are expected to be efficiently metabolised and are not expected to saturate the metabolic pathways.
For the substances in this group the available genotoxicity data do not preclude the evaluation of the candidate substances using the Procedure.
It is anticipated that the candidate substances in FGE.20Rev4 would 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.
It is considered that on the basis of the default MSDI approach the 45 candidate 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 770 to 120000 microgram/person/day for 41 flavouring 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 six flavouring substances [FL-no: 05.129, 05.142, 05.153, 05.158, 08.080 and 09.858]. The estimated intakes, based on the mTAMDI, of the four flavouring substances [FL-no: 02.205, 05.066, 05.221 and 06.104] assigned to structural class II were 3900, 1600, 7000 and 3900 microgram/person/day, respectively, which are all above the threshold of concern for the structural class (540 microgram/person/day for structural class II). 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, on the basis of the mTAMDI, the estimated intakes for 39 flavouring substances considered in this Opinion, exceed the relevant threshold for their structural class to which the flavouring substance has been assigned. Therefore, for these 39 substances more reliable exposure data are required. On the basis of such additional data, these flavouring substances should be re-evaluated using the Procedure. Subsequently, additional toxicological data might become necessary.
In order to determine whether the conclusion for the 45 candidate 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 for the materials of commerce have been provided for each of the 45 flavouring substances.
For these 45 flavouring substances the Panel concluded that they would present no safety concern at their estimated levels of intake based of the MSDI approach.
Flavourings, safety, benzyl alcohols, benzaldehydes, benzoic acids, esters, acetals, FGE.20, revision