Scientific Opinion on Flavouring Group Evaluation 9, Revision 6 (FGE.09Rev6): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 and 30, and an ester of a phenol derivative from chemical group 25

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2015;13(9):4243 [81 pp.].
doi
10.2903/j.efsa.2015.4243
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fátima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldrá, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu.
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings, Ulla Beckman Sundh, Leon Brimer, Karl-Heinz Engel, Paul Fowler, Rainer Gürtler, Trine Husøy, Wim Mennes, Gerard Mulder and Harriet Wallin, for the preparatory work on this scientific opinion and hearing experts Vibe Beltoft and Karin Nørby and EFSA staff Annamaria Rossi, Maria Carfi and Maria Anastassiadou for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2015-00318
Adopted
9 September 2015
Published
30 September 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 22 flavouring substances in the Flavouring Group Evaluation 9, Revision 6, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances was 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 present revision of FGE.09 includes the assessment of one additional flavouring substance, trans-3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one [FL-no: 07.219]. The Panel concluded that the 22 substances [FL-nos: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.219, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for 11 flavouring substances [FL-nos: 07.059, 07.109, 07.202, 07.203, 09.154, 09.520, 09.618, 09.619, 09.843, 09.935 and 09.949] more reliable exposure data are required for a re-evaluation. For two substances [FL-nos: 07.219 and 09.929] no use levels are available and these should be submitted. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have been considered. Specifications, including complete purity criteria and identity for the materials of commerce, have been provided for all candidate substances.

Summary

Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion 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 22 flavouring substances in the Flavouring Group Evaluation (FGE) 9, Revision 6 (FGE.09Rev6), using the Procedure referred to in Commission Regulation (EC) No 1565/2000 “(hereinafter ‘the Procedure’)”. These flavouring substances belong to chemical groups 8, 25 and 30 of Annex I of the Commission Regulation (EC) No 1565/2000.

The present revision of FGE.09, FGE.09Rev6, includes the assessment of one additional candidate substance, trans-3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one [FL-no: 07.219], which was not included in FGE.09Rev5. This substance is an α,β-unsaturated carbonyl, for which concern for genotoxicity was ruled out in FGE.212Rev3.

FGE.09Rev6 deals with 22 candidate substances: secondary alicyclic saturated and unsaturated alcohols, ketones, one hemiketal ester and esters containing secondary alicyclic alcohols.

Two candidate substances [FL-nos: 07.203 and 07.255] possess one chiral centre and 15 substances [FL-nos: 02.075, 02.167, 06.136, 07.059, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949] possess two or more chiral centres.

Fourteen candidate substances belong to structural class I, seven substances belong to structural class II and one to structural class III according to the decision tree approach presented by Cramer et al. (1978).

Fifteen 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 capitaintakes 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 Flavour 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 the Flavour 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, intakes in Europe of the 14 flavouring substances belonging to structural class I range from 0.0012 to 830 µg per capita per day, intakes of the seven substances from structural class II range from 0.0085 to 530 µg per capita per day and intake of the substance from structural class III is 1.2 µg per capita per day. These intakes are all below the threshold of concern values for structural classes I, II and III of 1 800, 540 and 90 µg per person per day, respectively. For one substance [FL-no: 09.520] from structural class II the MSDI is 770 µg per capitaper day, which is above the threshold of concern of 540 µg per person per day. For this substance a No Observed Adverse Effect Level (NOAEL) is available, providing a sufficient margin of safety based on the MSDI approach.

The total combined intakes of candidate and supporting substances from structural classes I and II do not give rise to a safety concern.

For five of the candidate substances [FL-nos: 07.109, 07.202, 07.219, 07.255 and 09.870] it has been concluded that a concern for genotoxicity, indicated by the presence of a structural alert, could be ruled out based on experimental data for supporting substances. Genotoxicity data are available for only a limited number of the remaining flavouring substances in the present group and the genotoxicity cannot be assessed adequately. However, the data available do not preclude evaluation of the substances using the Procedure.

All candidate substances are expected to be metabolised to innocuous products at the estimated levels of use as flavouring substances.

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 the 22 candidate substances would not give rise to safety concerns at the estimated levels of intake arising from their use as flavouring substances based on the default MSDI approach.

In order to determine whether the conclusion for the 22 candidate substances, which have been evaluated using the Procedure, can be applied to the materials of commerce, it is necessary to consider the available specifications. Specifications, including complete purity criteria and information on identity for the materials of commerce, have been provided for all flavouring substances.

Thus, for 22 flavouring substances evaluated using the Procedure, the Panel considered that the materials of commerce would not present a safety concern at their estimated levels of intake based on the MSDI approach [FL-nos: 02.070, 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.219, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 and 09.949].

The estimated intakes of 13 candidate substances in structural class I, based on the mTAMDI approach, ranged from 420 to 63 000 µg per person per day. For six substances [FL-nos: 09.154, 09.618, 09.619, 09.843, 09.935 and 09.949], the mTAMDI is above the threshold of concern of 1 800 µg per person per day. For seven substances [FL-nos: 02.070, 02.075, 02.135, 02.167, 09.355, 09.621 and 09.870], the mTAMDI is below the threshold. The mTAMDIs of five substances assigned to structural class II [FL-nos: 07.059, 07.109, 07.202, 07.203 and 09.520] range from 1 600 to 8 700 µg per person per day, which are above the threshold of concern for structural class II substances of 540 µg per person per day. The mTAMDI estimates for one substance from structural class II [FL-no: 07.255] and for the one candidate substance in class III [FL-no: 06.136] are 320 and 0.075 µg per person per day, respectively, which are below the thresholds of their structural classes (540 and 90 µg per person per day). For all substances with mTAMDI values below their structural class thresholds, the Panel noted that they have been evaluated using the A-side of the Procedure.

For one flavouring substance [FL-no: 09.929] from structural class I and one flavouring substance [FL-no: 07.219] from structural class II, use levels are missing and an mTAMDI cannot be calculated for these two substances.

In conclusion, for 11 candidate substances [FL-nos: 07.059, 07.109, 07.202, 07.203, 09.154, 09.520, 09.618, 09.619, 09.843, 09.935 and 09.949], for which the mTAMDIs are above the thresholds for their structural class, and for another two substances [FL-nos: 07.219 and 09.929], for which use levels are missing, further information is required. This would include more reliable intake data and then, if required, additional toxicological data.

Keywords
flavourings, alcohols, ketones, esters, secondary alicyclic, saturated, unsaturated, food safety, FGE.09
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Number of Pages
81