Literature DB >> 33552300

Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan-substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings.

Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert-Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Matthew Wright, Romualdo Benigni, Claudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Gisela Degen, Daniel Marzin, Camilla Svendsen, Maria Carfì, Giorgia Vianello, Wim Mennes.   

Abstract

The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already been considered in FGE.67 and its revisions (FGE.67Rev1 and FGE.67Rev2). During the current assessment, two substances were no longer supported by industry, therefore 12 candidate substances are evaluated in FGE.67Rev3. New genotoxicity and toxicity data are available for 2-pentylfuran [FL-no: 13.059] and 2-acetylfuran [FL-no: 13.054], which are representative substances of subgroup IV [FL-no: 13.069, 13.106, 13.148] and VI-B [FL-no: 13.045, 13.070, 13.083, 13.101, 13.105, 13.138, 13.163], respectively. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for both [FL-no: 13.054] and [FL-no: 13.059] and consequently for the substances that they represent. Since the candidate substances cannot be anticipated to be metabolised to innocuous products only, they were evaluated along the B-side of the Procedure. The Panel derived a NOAEL of 22.6 mg/kg bw per day and a BMDL of 8.51 mg/kg bw per day, for 2-acetylfuran and 2-pentylfuran, respectively. For all 12 substances sufficient margins of safety were calculated when based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 23 flavouring substances. The Panel agrees with JECFA conclusions, for all 23 substances, 'No safety concern at estimated levels of intake as flavouring substances' based on the MSDI approach. For 18 substances [FL-no: 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.054, 13.059, 13.074, 13.083, 13.101, 13.105, 13.106, 13.138, 13.148, 13.163 and 13.190], the mTAMDI intake estimates are above the threshold of toxicological concern (TTC) for their structural classes and more reliable data on uses and use levels are required to finalise their evaluation.
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Entities:  

Keywords:  FGE.13; FGE.67; Flavourings; furan‐substituted

Year:  2021        PMID: 33552300      PMCID: PMC7856567          DOI: 10.2903/j.efsa.2021.6362

Source DB:  PubMed          Journal:  EFSA J        ISSN: 1831-4732


  51 in total

1.  Evaluation of certain food additives and contaminants. Forty-ninth report of the Joint FAO/WHO Expert Committee on Food Additives.

Authors: 
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Review 2.  International Commission for Protection Against Environmental Mutagens and Carcinogens. Genotoxicity under extreme culture conditions. A report from ICPEMC Task Group 9.

Authors:  D Scott; S M Galloway; R R Marshall; M Ishidate; D Brusick; J Ashby; B C Myhr
Journal:  Mutat Res       Date:  1991-03       Impact factor: 2.433

3.  Scientific Opinion on Flavouring Group Evaluation 7, Revision 5 (FGE.07Rev5): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5.

Authors:  Vittorio Silano; Claudia Bolognesi; Laurence Castle; Jean-Pierre Cravedi; Karl-Heinz Engel; Paul Fowler; Roland Franz; Konrad Grob; Rainer Gürtler; Trine Husøy; Sirpa Kärenlampi; Maria Rosaria Milana; André Penninks; Maria de Fátima Tavares Poças; Andrew Smith; Christina Tlustos; Detlef Wölfle; Holger Zorn; Corina-Aurelia Zugravu; Ulla Beckman Sundh; Leon Brimer; Pasquale Mosesso; Gerard Mulder; Maria Anastassiadou; Wim Mennes
Journal:  EFSA J       Date:  2017-03-08

Review 4.  A general theory of effect size, and its consequences for defining the benchmark response (BMR) for continuous endpoints.

Authors:  Wout Slob
Journal:  Crit Rev Toxicol       Date:  2016-11-02       Impact factor: 5.635

5.  Salmonella mutagenicity tests: II. Results from the testing of 270 chemicals.

Authors:  K Mortelmans; S Haworth; T Lawlor; W Speck; B Tainer; E Zeiger
Journal:  Environ Mutagen       Date:  1986

6.  Evaluation of certain food additives and contaminants. Forty-sixth report of the Joint FAO/WHO Expert Committee on Food Additives.

Authors: 
Journal:  World Health Organ Tech Rep Ser       Date:  1997

7.  Mutagenicity of beta-alkyl substituted acrolein congeners in the Salmonella typhimurium strain TA100 and genotoxicity testing in the SOS chromotest.

Authors:  E Eder; C Deininger; T Neudecker; D Deininger
Journal:  Environ Mol Mutagen       Date:  1992       Impact factor: 3.216

8.  The possible role of alpha, beta-unsaturated carbonyl compounds in mutagenesis and carcinogenesis.

Authors:  E Eder; S Scheckenbach; C Deininger; C Hoffman
Journal:  Toxicol Lett       Date:  1993-04       Impact factor: 4.372

9.  2-Methylfuran toxicity in rats--role of metabolic activation in vivo.

Authors:  V Ravindranath; M G McMenamin; J H Dees; M R Boyd
Journal:  Toxicol Appl Pharmacol       Date:  1986-08       Impact factor: 4.219

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