Flavouring Group Evaluation 7, Revision 2 (FGE.07Rev2) : Saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5

Abstract

The present Flavouring Group Evaluation (FGE) deals with 43 saturated and unsaturated aliphatic secondary alcohols, ketones and esters with a secondary alcohol moiety.Twenty-two of the 43 candidate substances possess a chiral centre and two of the candidate substances possess two chiral centres. For six of these substances the stereoisomeric composition has not been specified.Due to the presence and the position of double bonds, six of the substances can exist as geometrical isomers. In three of these cases the stereoisomeric composition has not been specified.Twenty-eight of the flavouring substances have been assigned to structural class I and 15 substances belong to structural class II.Thirty-nine of the flavouring substances in the present group of 43 flavouring substances 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 capita intakes 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 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 43 flavouring substances in this group have intakes in Europe from 0.0012 to 1.3 microgram/capita/day, which are below the threshold of concern value for both structural class I (1800 microgram/person/day) and structural class II (540 microgram/person/day) substances.On the basis of available data from in vitro and in vivo tests on candidate and supporting substances, it can be concluded that the 43 flavouring substances included in this group exhibit no genotoxic potential.Among the 43 flavouring substances, 42 would be expected to be metabolised to innocuous products at the estimated levels of intake as flavouring substances. The remaining flavouring substance, 5-methylheptan-3-one .182], may be oxidised to a potential neurotoxic gamma-diketone. However, this metab...

Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched‐chain carboxylic acids from chemical group 5

“…In addition, the following documentation has been consulted for the safety evaluation of FGE.07Rev6: Genotoxicity data evaluated in FGE.201Rev2 (EFSA FAF Panel, 2018a ) and FGE.204Rev1 (EFSA FAF Panel, 2019 ); EFSA Scientific Opinion on FGE.07Rev5 (EFSA CEF Panel, 2017a ) and its revisions (EFSA AFC Panel, 2004 , 2008 ; EFSA CEF Panel, 2009 , 2010 , 2012 ); EFSA Scientific Opinion on FGE.63Rev3 (EFSA CEF Panel, 2017b ); EFSA Scientific Opinion on FGE.63Rev4 (EFSA FAF Panel, 2022 ). …”

“…EFSA Scientific Opinion on FGE.07Rev5 (EFSA CEF Panel, 2017a ) and its revisions (EFSA AFC Panel, 2004 , 2008 ; EFSA CEF Panel, 2009 , 2010 , 2012 );…”

“…The second revision of FGE.07, FGE.07Rev2 (EFSA CEF Panel, 2009 ) included the assessment of two additional substances [FL‐no: 02.255 and 07.239]. No new data on toxicity and metabolism were provided.…”