Following a request from the European commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was asked to deliver a scientific opinion on the implications for human health of chemically defined flavouring substances used in or on foodstuffs in the Member States. In particular, the Panel was requested to consider the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluations of flavouring substances assessed since 2000, and to decide whether no further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. These flavouring substances are listed in the Register, which was adopted by Commission Decision 1999/217/EC and its consecutive amendments.
The present revision of FGE.51, FGE.51Rev2, is due to new genotoxicity data evaluated in FGE.212Rev3 (EFSA CEF Panel, 2015a), which deals only with the genotoxic potential of a, b‑unsaturated flavouring substances. Based on these data, the Panel concluded that the data available could rule out the concern for genotoxicity for [FL-no: 07.033, 07.094, 07.112 and 07.140] and accordingly these substances can be evaluated through the Procedure in this revision. Three of these substances were evaluated by the JECFA at its 59th meeting in 2002 [FL-no: 07.033, 07.094 and 07.112] and the fourth was evaluated by the JECFA at its 63rd meeting. Since in the previous version of this FGE (FGE.51Rev1) 20 substances were discussed, the present revision will address 24 flavouring substances.
The Panel concluded that the 24 substances in the JECFA flavouring groups of alicyclic ketones, secondary alcohols and related esters and monocyclic and bicyclic secondary alcohols, ketones and related esters are structurally related to the group of secondary alicyclic saturated and unsaturated alcohols, ketones and esters with secondary alicyclic alcohol moieties evaluated by EFSA in Flavouring Group Evaluation 09, Revision 6 (FGE.09Rev6) (EFSA CEF Panel, 2015b).
The chemical identity of [FL-no: 07.033] could not be unambiguously confirmed. Therefore the Panel could not consider the JECFA evaluation of this substance. The current revision of FGE.51 will consider only the safety of 23 JECFA-evaluated substances.
For all 23 substances considered in this FGE, the Panel concluded that either they did not raise a concern with respect to genotoxicity, or that concerns with respect to genotoxicity due to the presence of a structural alert for this could be ruled out, based on experimental data.
The Panel agrees with the application of the Procedure as performed by the JECFA for the 23 substances considered in this FGE.
For 23 JECFA evaluated alicyclic ketones, secondary alcohols and related esters [FL-no: 02.209, 07.034, 07.035, 07.045, 07.094, 07.095, 07.098, 07.112, 07.126, 07.129, 07.140, 07.148, 07.149, 07.172, 07.179, 07.180, 07.257, 09.027, 09.140, 09.160, 09.230, 09.464 and 09.930] the Panel agrees with the JECFA conclusion ‘no safety concern at estimated levels of intake as flavouring substance’ based on the MSDI approach.
In order to determine whether the conclusion for the JECFA-evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications: Adequate specifications including complete purity criteria and identity tests are available for 21 JECFA-evaluated substances. For [FL-no: 07.094 and 07.112] information on the solubility in water and ethanol is missing and therefore the conclusions on the named substance cannot be applied to the materials of commerce that correspond to these two FL-numbers. For substance [FL-no: 07.033] unambiguous information with respect to the chemical identity should be provided.
For all substances evaluated through the Procedure use levels are needed to calculate the modified theoretical added maximum daily intake (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.