Scientific Opinion on Flavouring Group Evaluation 90, Revision 1 (FGE.90Rev1): consideration of six substances evaluated by JECFA (68th meeting) structurally related to aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters evaluated by EFSA in FGE.18Rev1 and FGE.75Rev1

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2016;14(1):4336 [37 pp.].
doi
10.2903/j.efsa.2016.4336
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, Wim Mennes, Maria Rosaria Milana, André Penninks, Maria de Fatima Tavares Poças, Vittorio Silano, Andrew Smith, Christina Tlustos, Fidel Toldra, Detlef Wölfle and Holger Zorn.
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 the 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-2013-00195
EFSA-Q-2013-00196
Adopted
2 December 2015
Published
13 January 2016
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 EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of six aliphatic, acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances evaluated by JECFA at the 68th meeting in 2007. This revision of FGE.90 is made because additional toxicity data have become available for a structurally related substance in FGE.75Rev1, anhydrolinalool oxide (5) [FL-no: 13.097]. The Panel agrees with the application of the Procedure as performed by the JECFA for four substances [FL-no: 02.018, 02.245, 02.250 and 02.251]. For two substances [FL-no: 13.076 and 13.087] it could not be concluded that they are metabolised to innocuous substances. Based on the exposure estimates (MSDI) and the no observed adverse effect level (NOAEL) from 90-day toxicity study with anhydrolinalool oxide (5), the Panel considered that the substances [FL-no: 13.076 and 13.087] were not of safety concern at the estimated levels of intake based on the maximised survey-derived daily intake (MSDI) approach. The specifications for the materials of commerce have also been considered. For substance [FL-no: 02.251] information on the stereoisomeric composition has not been specified, and for substance [FL-no: 13.087], the identity of the isomers needs to be specified. For three substances [FL-no: 02.018, 13.076 and 13.087] the modified theoretical added maximum daily intake (mTAMDI) is above the threshold of concern and therefore more reliable exposure data are required to perform a more refined exposure estimation and to judge whether a re-evaluation according to the Procedure is needed.

Summary

Following a request from the European Commission, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion 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 consider the Joint FAO/WHO Expert Committee on Food Additives (the JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.

In Flavouring Group Evaluation 90 (FGE.90), the European Food Safety Authority (EFSA) considered six flavouring substances from a group of flavouring substances consisting of acyclic and alicyclic terpenoid tertiary alcohols and structurally related substances evaluated by JECFA at the 68th meeting. The JECFA has evaluated a group of 15 flavouring substances consisting of aliphatic, acyclic and alicyclic terpenoid tertiary alcohols, and structurally related substances. Two of the JECFA evaluated substances are not in the Register ((±)-ethyl 2-hydroxy-2-methylbutyrate, JECFA no: 1651 and (±)-ethyl 2-hydroxy-3-methylbutyrate, JECFA no: 1652). Seven tertiary alcohols [FL-no: 02.035, 02.037, 02.042, 09.086, 09.227, 09.232 and 09.509] have been considered in FGE.89. Therefore, this consideration only deals with six substances.

This revision of FGE.90 is made because EFSA received new toxicity data on anhydrolinalool oxide [FL-no: 13.097] from FGE.75 which support the evaluation of [FL-no: 13.076 and 13.087] in this FGE.

The Panel concluded that the six substances [FL-no: 02.018, 02.245, 02.250, 02.251, 13.076 and 13.087] are structurally related to the aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters evaluated by EFSA in the Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3).

The Panel agrees with the way the application of the Procedure has been performed by the JECFA for four of the six substances [FL-no: 02.018, 02.245, 02.250 and 02.251]. For the remaining two substances [FL-no: 13.076 and 13.087], no metabolism data are available, neither for the substances themselves nor for related substances. Therefore, in contrast to the JECFA, the Panel cannot conclude that these substances are metabolised to innocuous products and they should accordingly be evaluated via the B-side of the Procedure scheme. The present revision of FGE.90, FGE.90Rev1, includes the consideration of new available toxicity data made available since the publication of FGE.90. A no observed adverse effect level (NOAEL) of 52 mg/kg body weight (bw) was derived from a 90-day study in rats for the structurally related substance anhydrolinalool oxide. Compared with an exposure estimate of 0.12 µg /capita per day for both [FL-no: 13.076 and 13.087], a margin of safety of 26 × 106 can be calculated.

Thus for four substances [FL-no: 02.018, 02.245, 02.250 and 13.076], the Panel agrees with the JECFA conclusion ‘no safety concern at estimated level of intake as flavouring substances’ based on the MSDI approach.

For the six substances, use levels have been provided by the Industry [FL-no: 02.018, 02.245, 02.250, 02.251, 13.076 and 13.087]. The modified theoretical added maximum daily intake (mTAMDI) figures calculated for three of the six substances [FL-no: 02.018, 13.076 and 13.087] are above the threshold of concern for their structural classes. For these substances, more reliable exposure data are needed. On the basis of such data, the substances should be reconsidered using the Procedure.

Adequate specifications are available for four out of six materials of commerce. For substance [FL-no: 02.251] information on the stereoisomeric composition and for substance [FL-no: 13.087] the identity of the isomers and the stereoisomeric composition needs to be specified.

Keywords
food safety, tertiary alcohols, flavourings, JECFA 68th meeting, FGE.18Rev1
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Number of Pages
37