Scientific Opinion on Flavouring Group Evaluation 3, Revision 2 (FGE.03Rev2): Acetals of branched- and straight-chain aliphatic saturated primary alcohols and branched- and straight-chain saturated or unsaturated aldehydes, an ester of a hemiacetal and an

Flavourings,

doi:10.2903/j.efsa.2011.2312

Cited by 8 publications

(4 citation statements)

References 16 publications

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“…Based on these distributions, the mean and the 95th percentile of exposure were calculated per survey and population group. The 95th percentile of exposure was only calculated for those population groups with a sufficiently large sample size to obtain a reliable estimate (EFSA, 2011).…”

Section: Exposure Assessment Of the Primary Productmentioning

confidence: 99%

“…hydroxyacetaldehyde), which is expected to be completely metabolised to endogenous metabolites carbon dioxide or glycolic acid and oxalic acid (WHO, 2002). According to the applicant these considerations may support the absence of concern for genotoxicity in vivo for the target substance, also considering read-across with substances in FGE.03Rev2 (EFSA CEF Panel, 2011) andFGE.10Rev3 (EFSA CEF Panel, 2012).…”

Section: B2mentioning

confidence: 99%

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Scientific opinion on the renewal of the authorisation of proFagus Smoke R714 (SF‐001) as a smoke flavouring Primary Product

Younes,

Aquilina,

Castle

et al. 2023

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product proFagus Smoke R714 (SF-001), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. ProFagus Smoke R714 is obtained by pyrolysis of beech and oak woods as main source materials. Based on the compositional data, the Panel noted that the identified and quantified proportion of the solvent-free fraction amounts to 39 weight (wt)%, thus the applied method does not meet the legal quality criterion that at least 50% of the solvent-free fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.7 to 10.9 mg/kg body weight (bw) per day at the mean and from 2.2 to 42.5 mg/kg bw per day at the 95th percentile. The Panel concluded that three components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan-2(5H)-one, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for this component are above the threshold of toxicological concern (TTC) of 0.0025 lg/kg bw per day for DNA-reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity.

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Section: Exposure Assessment Of the Primary Productmentioning

confidence: 99%

Section: B2mentioning

confidence: 99%

Scientific opinion on the renewal of the authorisation of proFagus Smoke R714 (SF‐001) as a smoke flavouring Primary Product

Younes,

Aquilina,

Castle

et al. 2023

EFS2

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“…Experimental studies indicate that acetals may also be hydrolysed enzymatically in the liver and probably also in other tissues. Nevertheless, hydrolysis data on acetals show that it cannot be excluded that a fraction of an oral dose of the parent acetals may reach the systemic circulation (JECFA, 2002;EFSA CEF Panel, 2011). Therefore, acetals can be anticipated to be metabolised to innocuous substances through (acidic or enzymatic) hydrolysis, oxidation and normal fatty acid metabolism, including b-oxidation and citric acid cycle, which finally leads to their total oxidation.…”

Section: Adme Datamentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 61 Revision 2 (FGE.61Rev2): consideration of aliphatic acetals evaluated by JECFA (57th, 63rd and 68th meetings) structurally related to acetals evaluated by EFSA in FGE.03Rev2

Flavourings¹,

Younes²,

Aquilina³

et al. 2020

EFS2

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The EFSA Panel on Food Additives and Flavourings was requested to evaluate 12 flavouring substances attributed to the Flavouring Group Evaluation 61 (FGE.61), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.61 and FGE.61Rev1 [FL-no: 06.001, 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037, 06.081]. The remaining three substances [FL-no: 06.025, 06.031 and 06.072] have been cleared with respect to genotoxicity in FGE.200Rev1 and are considered in this revision 2 of FGE.61. 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 12 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. For nine flavouring substances 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037 and 06.081], use levels are still needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) values in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation accordingly.

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“…However, thioacetals are more resistant to hydrolysis than oxygen acetals. In addition, chances of hydrolysis would be reduced even more by their cyclic character (Smith and March, 2001;EFSA CEF Panel, 2011c). It is thus anticipated that these substances may be expected to reach the intestinal lumen intact and may also be absorbed as such.…”

Section: Metabolitesmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

Flavourings¹

2013

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate 59 flavouring substances in the Flavouring Group Evaluation 21, Revision 4, using the Procedure in Commission Regulation (EC) No 1565/2000. This revision is made due to the inclusion of the assessment of new toxicity data on one supporting substance 5,6-dihydro-2,4,6-tris(2-methylpropyl)-4H-1,3,5-dithiazine , which is considered to be structurally related to the candidate substances 2-butyl-4-methyl(4H)pyrrolidino[1,2d]-1,3,5-dithiazine .042], dihydro-2,4,6-triethyl-1,3,5(4H)-dithiazine .054], 2,4-dimethyl(4H)pyrrolidino[1,2e]-1,3,5-dithiazine .055], 4,6-dimethyl-2-(1-methylethyl)dihydro-1,3,5-dithiazine .057], 2-isobutyldihydro-4,6-dimethyl-1,3,5-dithiazine [FLno: 15.079] and ethyl thialdine . Furthermore, new in vitro genotoxicity studies have become available on the supporting substance 2-acetyl-2-thiazoline .010], which is considered to be structurally related to and a supportive substance for 2-methyl-2-thiazoline . Eighteen of the original 59 candidate substances 15.042, 15.043, 15.064, 15.070, 15.072, 15.077, 15.088, 15.090, 15.091, 15.092, 15.094, 15.099, 15.106, 15.107, 15.114, 15.129 and 15.133], for which additional data were requested, are no longer supported by Industry for use as flavouring substances in Europe and will therefore not be considered any further. Therefore, FGE.21Rev4 will only deal with 41 candidate substances. Two of the substances, 3-thiazolines, 2,4-dimethyl-3-thiazoline .060] and 2-isobutyl-3-thiazoline [FLno: 15.119], were considered to have genotoxic potential. The remaining 39 substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that 32 flavouring substances 15.039, 15.044, 15.050, 15.051, 15.052, 15.054, 15.055, 15.057, 15.058, 15.061, 15.062, 15.063, 15.067, 15.068, 15.069, 15.071, 15.078, 15.079, 15.080, 15 All candidate substances are five-or six-member sulphur-containing heterocyclic compounds, some of which also contain nitrogen. They have been divided into two main groups, those with an aromatic ring (33 candidate substances) (Group A) and those with a non-aromatic ring structure (eight candidate substances) (Group B). All are ring-substituted with one or more of the substituents alkyl, alkenyl, aryl, alcohol, keto and thio. For assessment purposes, the following further subdivision of groups (A) and (B) has been made: Thirty-four of the candidate substances belong to structural class II and seven belong to structural class III.Thirty-one of the candidate substances have been reported to occur naturally in a wide range of foods.In its evaluation, the Panel as a default used the "Maximised Survey-derived Daily Intake" (MSDI) approach to estimate the per capita intakes of the flavouring substances in Europe. Howev...

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Scientific Opinion on Flavouring Group Evaluation 3, Revision 2 (FGE.03Rev2): Acetals of branched- and straight-chain aliphatic saturated primary alcohols and branched- and straight-chain saturated or unsaturated aldehydes, an ester of a hemiacetal and an

Cited by 8 publications

References 16 publications

Scientific opinion on the renewal of the authorisation of proFagus Smoke R714 (SF‐001) as a smoke flavouring Primary Product

Scientific opinion on the renewal of the authorisation of proFagus Smoke R714 (SF‐001) as a smoke flavouring Primary Product

Scientific Opinion on Flavouring Group Evaluation 61 Revision 2 (FGE.61Rev2): consideration of aliphatic acetals evaluated by JECFA (57th, 63rd and 68th meetings) structurally related to acetals evaluated by EFSA in FGE.03Rev2

Scientific Opinion on Flavouring Group Evaluation 21, Revision 4 (FGE.21Rev4): Thiazoles, thiophenes, thiazoline and thienyl derivatives from chemical groups 29 and 30

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