Scientific Opinion on Flavouring Group Evaluation 9, Revision 5 (FGE.09Rev5): Secondary alicyclic saturated and unsaturated alcohols, ketones and esters containing secondary alicyclic alcohols from chemical group 8 and 30, and an ester of a phenol derivat

Abstract

None of the substances were considered to have genotoxic potential. 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. The Panel concluded that the 21 substances 02.075, 02.135, 02.167, 06.136, 07.059, 07.109, 07.202, 07.203, 07.255, 09.154, 09.355, 09.520, 09.618, 09.619, 09.621, 09.843, 09.870, 09.929, 09.935 Seventeen of the flavouring substances have one or more chiral centres.Fourteen of the flavouring substances belong to structural class I, six belong to structural class II and one to structural class III, according to the decision tree approach presented by Cramer et al., 1978. Fourteen of the 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 14 flavouring substances belonging to structural class I have intakes in Europe ranging from 0.0012 to 830 µg/capita/day, for five of the six substances from structural class II the intakes range from 0.0085 to 530 µg/capita/day, and for the substance from structural class III the intake is 1.2 µg/capita/day, which are all below their respective threshold of concern value for structural class I, II or III of 1800, 540 or 90 µg/person/day, respectively. For one substance .520] from structural class II the MSDI is 770 µg/capita/day, which is above the threshold of concern of 540 µg/person/day, however, an NOAEL provides a sufficient margin of safety and therefore do the total combined intakes of the candidate and suppor...

Safety and efficacy of secondary aliphatic saturated or unsaturated alcohols, ketones, ketals and esters with a second secondary or tertiary oxygenated functional group belonging to chemical group 10 when used as flavourings for all animal species

“…The data for human exposure in the EU (EFSA, 2008a, 2009, EFSA CEF Panel, 2014b,c) ranges from 0.024 to 2,300 lg/person per day, corresponding to 0.011-106.7 lg/kg 0.75 per day. The data for human exposure in the EU (EFSA, 2008a, 2009, EFSA CEF Panel, 2014b,c) ranges from 0.024 to 2,300 lg/person per day, corresponding to 0.011-106.7 lg/kg 0.75 per day.…”

“…The first approach to the safety assessment for target species takes account of the applied use levels in animal feed relative to the maximum reported exposure of humans on the basis of the metabolic body weight. The data for human exposure in the EU (EFSA, 2008a, 2009, EFSA CEF Panel, 2014b) ranges from 0.024 to 2,300 lg/person per day, corresponding to 0.011-106.7 lg/kg 0.75 per day. Table 3 summarises the result of the comparison with human exposure for representative target animals.…”