Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Flavouring Group Evaluation 7 (FGE.07): Saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secon

Abstract

The present Flavouring Group Evaluation deals with 35 saturated and unsaturated aliphatic secondary alcohols, ketones and esters with secondary alcohol moiety.Seventeen of the 35 flavouring substances possess one chiral centre, two flavouring substances possess two chiral centres, and three flavouring substances can exist as geometrical isomers. In nine of these cases, the substance has been presented without any indication whether the commercial flavouring substance was dominated by one isomer or the other.Twenty-three of the flavouring substances have been assigned to structural class I, and 12 substances belong to structural class II.Thirty-three of the flavouring substances in the present group of 35 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 Intakes (MSDIs) approach to estimate the per capita intakes of the flavouring substances in Europe. However, when the Panel examined the information provided by the European flavouring 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 2 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 35 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.Among the 35 flavouring substances, 34 might be expected to be metabolised to innocuous products at the estimated levels of intake as flavouring substances. One flavouring substance, 5-methyl-3-heptanone, may potentially be oxidised to a neurotoxic gamma-diketone, but a NOAEL for this substance could be established which provided a large margin of safety in relation to the estimated level of intake of the flavouring substance.On the basis of available data from in vitro and in vivo tests on candidate and supporting substances, it can be concluded th...

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 );…”

“…For two of the newly allocated substances [FL‐no: 07.162 and 07.201], data on metabolism were provided. Furthermore, additional information on 20 flavouring substances [FL‐no: 02.124, 02.142, 02.148, 02.177, 02.182, 02.183, 07.156, 07.157, 07.182, 07.185, 07.205, 09.304, 09.323, 09.325, 09.328, 09.332, 09.386, 09.388, 09.391 and 09.880] was made available since the first publication of FGE.07 (EFSA AFC Panel, 2004 ).…”

“…(EFSA FAF Panel, 2019); -EFSA Scientific Opinion on FGE.07Rev5 (EFSA CEF Panel, 2017a) and its revisions (EFSA AFC Panel, 2004EFSA 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).…”