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

Abstract

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 [FLno: 02.216] and 12-alpha-santalen-14-ol ]. 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 [FLnos: 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.

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“…In agreement, the FDA considers β-ionone to be Generally Recognized as a Safe (GRAS, 21 CFR 172.515) chemical for its intended use in food. It is also included in the list of flavorings authorized by the EU according to the evaluation carried out by EFSA [133]. Regarding use in feed, β-ionone is considered safe at the normal use level (5 mg/kg complete feed) for salmonids, veal calves and dogs, whereas for the remaining target species, the use level of 1 mg/kg complete feed is considered safe [134].…”

“…However, it should be considered that the CLP classification is exclusively hazard-based and that no other information about risks is available, especially after repeated exposure. Isocyclocitral is also included in the list of flavorings authorized by the EU, according to the evaluation carried out by the EFSA [133], in which it is reported that, based on chemical structure, the compound is expected to be oxidized to the corresponding carboxylic acid, conjugated with glucuronic acid and excreted as urinary metabolites. Since apart from an acute toxicity study, cited in the ECHA dossier as grey literature but not available (Registration Dossier-ECHA (europa.eu)), no further data have been produced.…”

“…Since apart from an acute toxicity study, cited in the ECHA dossier as grey literature but not available (Registration Dossier-ECHA (europa.eu)), no further data have been produced. The evaluation of β-cyclocitral toxicity has been carried out by applying the Threshold of Toxicological Concern (TTC) approach [139]: β-cyclocitral belongs to Cramer Class I (characterized by low toxicity) and therefore, levels below the threshold of 1800 µg/person per day are expected not to induce any relevant health effect in an adult of 60 Kg bw [133]. This was also the approach followed by RIVM, evaluating isocyclocitral when used as a fragrance [140] Consequently, the identification of the level of exposure is crucial to understand the toxicity of β-cyclocitral, produced in water.…”

Scientific Opinion on Flavouring Group Evaluation 73, Revision 4 (FGE.73Rev4): consideration of alicyclic alcohols, aldehydes, acids and related esters evaluated by JECFA (59th and 63rd meeting) structurally related to primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters evaluated by EFSA in FGE.12Rev5

“…Genotoxicity studies -text taken 9 from EFSA FGE.12Rev4 (EFSA CEF Panel, 2013c) Data are available for the supporting substance 2,6-dimethyl-2,5,7-octatriene-1-ol acetate ], but no studies on genotoxicity are available for the 12 candidate substances. The genotoxic potential of the remaining flavouring substances cannot be fully assessed as the data are limited.…”