Scientific Opinion on Flavouring Group Evaluation 12, Revision 4 (FGE.12Rev4): primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters from chemical groups 1 and 7
Résumé
The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety
Authority was requested to evaluate 12 flavouring substances in Flavouring Group Evaluation 12, Revision 4
(FGE.12Rev4), including two additional substances, using the Procedure in Commission Regulation (EC)
No 1565/2000. The present revision includes two additional flavouring substances: 12-beta-santalen-14-ol [FL-
no: 02.216] and 12-alpha-santalen-14-ol [FL-no: 02.217]. None of the substances was 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 and the toxicological threshold of
concern and available data on metabolism and toxicity. The Panel concluded that none of the 12 substances [FL-
nos: 02.134, 02.186, 02.216, 02.217, 05.157, 05.182, 05.183, 05.198, 08.135, 09.342, 09.670 and 09.829] gives
rise to safety concerns at their levels of dietary intake, estimated on the basis of the maximised survey-derived
daily intake approach. Besides the safety assessment of these flavouring substances, the specifications for the
materials of commerce have also been considered. Specifications including complete purity criteria and identity
for the materials of commerce have been provided for all 12 candidate substances