Scientific Opinion on Flavouring Group Evaluation 78, Revision 1 (FGE.78Rev1): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic and aromatic hydrocarbons evaluated by EFSA in FGE.25Rev2

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011; 9(6):2178 [69 pp.].
doi
10.2903/j.efsa.2011.2178
Panel members at the time of adoption
Arturo Anadon, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary Waring, Detlef Wölfle
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Flavourings for the preparation of this Opinion: Ulla Beckman Sundh, Vibe Beltoft, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Karl-Heinz Engel, Henrik Frandsen, Rainer Gürtler, Frances Hill, Trine Husøy, John Christian Larsen, Catherine Leclercq, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerard Pascal, Iona Pratt, Gerrit Speijers, Harriet Wallin and EFSA’s staff member Kim Rygaard Nielsen for the preparatory work on this scientific Opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2010-01557
Adopted
19 May 2011
Published
29 June 2011
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 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 24 aliphatic, alicyclic and aromatic hydrocarbons evaluated by the JECFA (65th meeting). In the previous version of FGE.78, the Panel concluded that for 13 substances no applicable NOAEL was available for the substance itself or on a structurally related compound and therefore further data were required. Additional data (long term study of toxicity, mutagenicity studies and new tonnage figure) have now become available for beta-myrcene [FL-no: 01.008] and the present revision of FGE.78, FGE.78Rev1, includes the evaluation of these data. 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. Two substances [FL-no: 01.011 and 01.013] are genotoxic in vitro and potentially carcinogenic, and are therefore not evaluated using the Procedure. The Panel concluded that the nine substance [FL-no: 01.002, 01.005, 01.006, 01.010, 01.016, 01.019, 01.020, 01.045 and 01.077] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. For 13 substances [FL-no: 01.003, 01.004, 01.007, 01.008, 01.009, 01.014, 01.017, 01.018, 01.024, 01.026, 01.029, 01.040 and 01.061] additional toxicity data are requested. For one substance [FL-no: 01.024] EU production figure is needed to finalise the evaluation. Besides the safety assessment of these substances, the specifications for the materials of commerce have been considered. For two substances [FL-no: 01.018 and 01.061] the isomeric composition is lacking. For 14 substances [FL-no: 01.004, 01.007, 01.008, 01.009, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045 and 01.061] further information on the composition of mixture is requested.

Summary

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 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.

The present consideration concerns 24 aliphatic, alicyclic and aromatic hydrocarbons evaluated by the JECFA (65th meeting). The Panel concluded that the 24 substances are structurally related to the group of 37 aliphatic and aromatic hydrocarbons evaluated by EFSA in the Flavouring Group Evaluation 25, Revision 2 (FGE.25Rev2).

The Panel agrees with the application of the Procedure as performed by the JECFA for eight of the 24 substances considered in this FGE [FL-no: 01.002, 01.005, 01.006, 01.016, 01.019, 01.020, 01.045 and 01.077].

Two substances [FL-no: 01.011 and 01.013] are genotoxic in vitro and there are unresolved problems with potential carcinogenicity and therefore the Panel concluded that they cannot be evaluated using the Procedure.

For the following 14 substances [FL-no: 01.003, 01.004, 01.007, 01.008, 01.009, 01.010, 01.014, 01.017, 01.018, 01.024, 01.026, 01.029, 01.040 and 01.061] it cannot be concluded that they are metabolised to innocuous substances and therefore their evaluation should proceed along the B-side of the Procedure. For one of these substances, 1-isopropenyl-4-methylbenzene [FL-no: 01.010] from subgroup IVe (alkyl substituted benzene hydrocarbons), a NOAEL was available, giving an adequate margin of safety compared to the estimated level of intake. For 13 substances no applicable NOAEL is available for the substance itself or on a structurally related compound and therefore further data are required.

For one substance [FL-no: 01.024] the JECFA evaluation is only based on MSDI values derived from production figure from the USA. EU production figure is needed in order to finalise the evaluation of this substance.

For two substances use levels have been provided by the Industry [FL-no: 01.008 and 01.026]. The mTAMDI figures calculated were above the threshold of concern for structural class I to which the two substances belong. For these two substances more reliable exposure data are needed. On the basis of such additional data these flavouring substances should be reconsidered using the Procedure. For the remaining 22 substances evaluated through the Procedure use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessment to finalise the evaluation.

In order to determine whether the conclusion for the 24 JECFA evaluated 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 are available for 10 of the 24 JECFA evaluated substances. For two substances [FL-no: 01.018 and 01.061] information on the isomeric composition is lacking and for 14 substances [FL-no: 01.004, 01.007, 01.008, 01.009, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045 and 01.061] further information on the composition of the mixture is requested.

Thus, for 14 substances [FL-no: 01.004, 01.007, 01.008, 01.009, 01.017, 01.018, 01.019, 01.020, 01.024, 01.026, 01.029, 01.040, 01.045 and 01.061] the Panel has reservations (no European production volumes available, preventing them from being evaluated using the Procedure, and/or missing information on stereoisomerism/composition of mixture). For two of the 24 JECFA evaluated substances the Procedure could not be applied [FL-no: 01.011 and 01.013] due to concern with respect to genotoxicity and carcinogenicity. For 13 of the 24 JECFA evaluated aliphatic, alicyclic and aromatic hydrocarbons [FL-no: 01.003, 01.004, 01.007, 01.008, 01.009, 01.014, 01.017, 01.018, 01.024, 01.026, 01.029, 01.040 and 01.061] additional toxicity data are requested. For the remaining six substances [FL-no: 01.002, 01.005, 01.006, 01.010, 01.016 and 01.077] the Panel agrees with JECFA conclusion “no safety concern at estimated levels of intake as flavouring substances” based on the MSDI approach.

Keywords
Safety, flavouring, aliphatic, alicyclic, aromatic, hydrocarbons, JECFA, 63rd meeting, FGE.25Rev2, FGE.78.
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Number of Pages
69