Flavouring Group Evaluation 203: alpha, beta‐Unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double bonds and with or without additional non‐conjugated double bonds

Flavourings,

doi:10.2903/j.efsa.2009.877

Cited by 3 publications

(1 citation statement)

References 4 publications

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“…One carcinogenicity study is available on hexa-2(trans),4(trans)-dienal [FL-no: 05.057] (NTP, 2003) already considered in FGE.203 (EFSA CEF Panel, 2009b). This study has also been considered by JECFA at their 61st meeting (JECFA, 2004a).…”

Section: Carcinogenicity Studiesmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β‐unsaturated, di‐ and trienals and related alcohols, acids and esters evaluated by JECFA (61st‐68th‐69th meeting)

Flavourings¹,

Younes²,

Aquilina³

et al. 2019

EFS2

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The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.71 [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. The remaining 30 substances [FL‐no: 02.020, 02.050, 02.090, 02.112, 02.137, 02.156, 02.210, 05.037, 05.060, 05.070, 05.073, 05.076, 05.078, 05.102, 05.109, 05.150, 05.171, 05.179, 09.276, 09.277, 09.303, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.678 and 09.841] have been cleared with respect to genotoxicity in FGE.200Rev1 and they are considered in this revision. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 39 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL‐no: 08.073 and 09.235]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Normal and maximum use levels should be provided for nine flavouring substances [FL‐no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. For two flavouring substances [FL‐no: 02.020 and 05.076], the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) estimates are above the TTC for their structural class I. Therefore, additional information on uses and use levels should be provided for these eleven substances in order to finalise their evaluation.

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Section: Carcinogenicity Studiesmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β‐unsaturated, di‐ and trienals and related alcohols, acids and esters evaluated by JECFA (61st‐68th‐69th meeting)

Flavourings¹,

Younes²,

Aquilina³

et al. 2019

EFS2

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Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double‐bonds and with or without additional non‐conjugated double‐bonds

Silano¹,

Bolognesi²,

Castle³

et al. 2018

EFS2

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.057] was also tested in an in vivo gene mutation assay giving negative results. Both hexa-2(trans),4(trans)-dienal .057] and deca-2(trans),4(trans)-dienal .140] were tested in vivo for the induction of micronuclei in rats bone marrow and peripheral reticulocytes after oral or intraperitoneal administration. None of the two substances induced increased frequencies of micronuclei. The Panel concluded that the concern for genotoxicity can be ruled out for the representative substances hexa-2(trans),4(trans)-dienal .057] and deca-2(trans),4(trans)-dienal .140] and therefore also for the other substances in this group 02.153, 02.162, 02.188, 05.064,

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Scientific Opinion on Flavouring Group Evaluation 5, Revision 3 (FGE.05Rev3): Branched‐ and straight‐chain unsaturated aldehydes, dienals, unsaturated and saturated carboxylic acids and related esters with saturated and unsaturated aliphatic alcohols and a phenylacetic acid related ester from chemical groups 1, 2, 3, 5 and 15

Flavourings¹,

Younes²,

Aquilina³

et al. 2019

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate 54 flavouring substances attributed to the Flavouring Group Evaluation 05 (FGE.05), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. This Revision 3 includes 17 additional substances which have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL‐no: 02.192, 02.231, 05.072, 05.144, 05.184, 05.189, 05.190, 05.191, 05.195, 09.247, 09.400, 09.866, 09.948]) and in FGE.203Rev2 ([FL‐no: 05.081, 05.186, 05.194, 05.196]). The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 54 substances gives rise to safety concern at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for 10 substances ([FL‐no: 08.072, 08.083, 08.101, 08.119, 08.120, 09.181, 09.329, 09.335, 09.379 and 09.637]) for which quantitative figures on the composition of stereoisomeric mixtures are missing and for [FL‐no: 09.578] complete specifications should be provided. Normal and maximum use levels were not available for [FL‐no: 08.072, 08.083, 08.101, 08.119, 08.120, 09.287, 09.326 and 09.578]. Except for flavouring substances [FL‐no: 05.072, 05.081, 05.186, 05.194, 05.196, 09.934 and 09.942], more reliable intake data should be requested for all the 46 flavouring substances, for which use levels were submitted, as their modified Theoretical Added Maximum Daily Intake (mTAMDI) exposure estimates are above the threshold of concern for structural classes I and II. This would include more reliable intake data and then, if required, additional toxicological data.

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Flavouring Group Evaluation 203: alpha, beta‐Unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double bonds and with or without additional non‐conjugated double bonds

Cited by 3 publications

References 4 publications

Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β‐unsaturated, di‐ and trienals and related alcohols, acids and esters evaluated by JECFA (61st‐68th‐69th meeting)

Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β‐unsaturated, di‐ and trienals and related alcohols, acids and esters evaluated by JECFA (61st‐68th‐69th meeting)

Scientific Opinion on Flavouring Group Evaluation 203, Revision 2 (FGE.203Rev2): α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.4 of FGE.19 with two or more conjugated double‐bonds and with or without additional non‐conjugated double‐bonds

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