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Scientific Opinion on Flavouring Group Evaluation 12, Revision 3 (FGE.12Rev3): Primary saturated or unsaturated alicyclic alcohol, aldehyde, acid, and esters from chemical group 7
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 10 flavouring substances in the Flavouring Group Evaluation 12 (FGE.12), including an additional substance in revision 3, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to inclusion of one additional flavouring substance, 2,6,6-trimethylcyclohex-2-ene-1-carboxaldehyde [FL-no: 05.182]. 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 10 substances [FL-no: 02.134, 02.186, 05.157, 05.182, 05.183, 05.198, 08.135, 09.342, 09.670 and 09.829] 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. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all 10 candidate substances.
© European Food Safety Authority,2012
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 10 flavouring substances in the Flavouring Group Evaluation 12, Revision 3 (FGE.12Rev3), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. These 10 primary saturated or unsaturated alicyclic alcohol, aldehyde, acid and esters belong to chemical group 7, Annex I of the Commission Regulation (EC) No 1565/2000.
The present revision of FGE.12, FGE.12Rev3, includes the assessment of one additional flavouring substance, 2,6,6-trimethylcyclohex-2-ene-1-carboxaldehyde [FL-no: 05.182], compared to FGE.12Rev2.
Eight flavouring substances possess one or more chiral centres and additionally, due to the presence of a double bond, one of these substances can exist as geometric isomer. For all eight substances, the stereoisomeric composition has been specified sufficiently.
The 10 flavouring substances are classified into structural class I according to the decision tree approach presented by Cramer et al., 1978.
Four of the flavouring substances in the present group have been reported to occur in essential oils and in a few 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 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 10 flavouring substances in this group have intakes in Europe from 0.011 to 43 microgram/capita/day, which are below the threshold of concern value for structural class I (1800 microgram/person/day) substances.
The genotoxic potential of this group of flavouring substances cannot be assessed since information on the flavouring substances or on structurally related substances is missing. However, this does not preclude evaluation of the flavouring substances in the present group using the Procedure.
The flavouring substances are expected to be metabolised to innocuous products at the estimated levels of intake as flavouring substances.
It is considered that on the basis of the default MSDI approach these 10 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 they ranged from 2 to 5000 microgram/person/day for the 10 flavouring substances from structural class I. For six of the substances the intakes were above the threshold of concern for structural class I of 1800 microgram/person/day. Thus, for six 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 six substances [FL-no: 02.134, 02.186, 08.135, 09.342, 09.670 and 09.829] 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. The four substances which have mTAMDI intake estimates below the threshold of concern for structural class I are also expected to be metabolised to innocuous products.
In order to determine whether this evaluation could be applied to the material of commerce, it is necessary to consider the available specifications. Specifications including complete purity criteria and identity tests for the materials of commerce have been provided for each of the 10 flavouring substances.
For these 10 flavouring substances [FL-no: 02.134, 02.186, 05.157, 05.182, 05.183, 05.198, 08.135, 09.342, 09.670 and 09.829], the Panel concluded that they would present no safety concern at the estimated levels of intake based on the MSDI approach.
Primary alicyclic, saturated, unsaturated, alicyclic, alcohols, aldehydes, esters, flavourings, safety.