Scientific Opinion on Flavouring Group Evaluation 73, Revision 5 (FGE.73Rev5): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th, 63rd and 86th meeting) and structurally related to substances evaluated in FGE.12Rev5

Flavourings, Myrtenal, α,β‐unsaturated carbonyls, FGE.73 Rev4, JECFA
First published in the EFSA Journal
31 janvier 2020
Adopted
10 décembre 2019
Type
Scientific Opinion

Abstract

The EFSA Panel on Food Additives and Flavourings was requested to evaluate 24 flavouring substances assigned to the Flavouring Group Evaluation 73 (FGE.73), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty‐three substances have already been considered in FGE.73 and its four revisions ([FL‐no: 02.114, 02.141, 05.098, 05.112, 08.067, 09.289, 09.488, 09.534, 09.615, 05.119, 05.123, 08.034, 08.060, 09.028, 09.536, 05.104, 09.034, 09.712, 09.305, 02.060, 02.091, 09.278, 09.302]). The remaining substance myrtenal [FL‐no: 05.106] has been cleared with respect to genotoxicity in FGE.208Rev3 and is considered in this revision 5 of FGE.73. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 24 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 23 substances. For [FL‐no: 09.278], the stereoisomeric composition is not specified. For two substances [FL‐no: 09.034, and 09.712], the modified Theoretical Added Maximum Daily Intake (mTAMDI) estimates are above the TTC for their structural class (I). For 17 substances evaluated through the Procedure, no normal and maximum use levels are available. Therefore, for these 19 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations.

Substances
Myrtenal
Cas: 565-94-3
Inchi: InChI=1S/C11H16O/c1-8-4-5-9-6-11(8,7-12)10(9,2)3/h4,7,9H,5-6H2,1-3H3
Iupac: 2,6,6-trimethylbicyclo[3.1.1]hept-2-ene-1-carbaldehyde
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.5970
EFSA Journal 2020;18(1):5970
Question Number
On request from
European Commission