Flavouring Group Evaluation 87, Revision 3 (FGE.87Rev3): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and related esters evaluated in FGE.47Rev1.

The Panel on Food Additives and Flavourings (FAF) 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 19 bicyclic secondary alcohols, ketones and related esters evaluated by JECFA at the 63rd meeting. This revision of FGE.87 is made due to new information on annual production volume, allowing the calculation of maximised survey-derived daily intake (MSDI) for 4,4a,5,6-tetrahydro-7-methylnaphthalen-2(3H)-one [FL-no: 07.136]. In addition, new data on uses and use levels for the substances [FL-no: 07.089, 07.0136, 07.153 and 07.159] have been provided and considered for the estimation of exposure (mTAMDI approach). For [FL-no: 07.136], the Panel agrees with the Procedure as applied by JECFA and with JECFA conclusion: 'No safety concern at estimated levels of intake as flavouring substance', when based on the MSDI approach. For the other 18 substances considered in FGE.87Rev3, the same conclusion was already drawn in FGE.87Rev2. For [FL-no: 07.136], the mTAMDI exposure estimate is below the TTC for structural class II substances. Accordingly, no further data are required in the context of the current evaluation programme. For [FL-no: 07.089, 07.153, 07.159], mTAMDI exposure estimates are above the TTC for structural class II substances; therefore, more reliable data on uses and use levels should be provided in order to refine the exposure assessment and to finalise their safety evaluation. For the remaining 15 substances, use levels are needed to calculate the mTAMDIs in order to identify those flavouring substances that need more refined exposure assessments and to finalise the evaluation. Information on specifications for the materials of commerce is considered adequate for all 19 substances.