Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14

EFSA Panel on Food Additives, Flavourings (FAF), 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 BenigniClaudia Bolognesi, Kevin Chipman, Eugenia Cordelli, Gisela Degen, Daniel Marzin, Camilla Svendsen, Maria Carfì, Giorgia Vianello, Wim Mennes

Research output: Contribution to specialist publicationArticle

2 Citations (Scopus)

Abstract

The Panel on Food additives and Flavourings of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2-ethyl-5-methylfuran [FL-no: 13.125] and 2-octylfuran [FL-no: 13.162]. FGE.13 revision 3 (FGE.13Rev3) deals with 26 flavourings substances of which 24 have been already evaluated to be of no safety concern. For [FL-no: 13.125] and [FL-no: 13.162], a concern for genotoxicity was raised in FGE.13Rev1. This concern could be ruled out based on new genotoxicity data on supporting substances in FGE.67Rev3. Subsequently, [FL-no: 13.125 and 13.162] were evaluated, through a stepwise approach that integrates intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity, along the B-side of the Procedure, making use of a BMDL of 8.51 mg/kg body weight (bw) per day. The Panel derived this BMDL from an oral subchronic toxicity study with the supporting substance 2-pentylfuran [FL-no: 13.059]. Using this BMDL, for [FL-no: 13.125 and 13.162], adequate margins of safety were calculated based on the MSDI approach. The Panel concluded that the 26 candidate substances in FGE.13Rev3 do not give rise to safety concerns at their levels of dietary intake, when estimated on the basis of the MSDI approach. Adequate specifications for the materials of commerce have been provided for all 26 substances. Data on uses and use levels are needed for [FL-no: 13.130]. For 21 flavouring substances [FL-no: 13.011, 13.102, 13.108, 13.113, 13.114, 13.122, 13.125, 13.127, 13.129, 13.132, 13.133, 13.135, 13.136, 13.139, 13.141, 13.143, 13.146, 13.149, 13.162, 13.178 and 13.185], the mTAMDI intake estimates are above the TTC for their structural class and more reliable data on uses and use levels are required to finalise their evaluation.
Original languageEnglish
Pagese06386
Number of pages61
Volume19
No.2
Specialist publicationEFSA Journal
DOIs
Publication statusPublished - Feb 2021

Keywords

  • Furfuryl
  • Furan
  • Flavourings
  • sulfur-substituted
  • disulfide
  • trisulfide
  • thioester
  • FGE.13
  • 2-FURYL METHYL KETONE
  • REACTIVE METABOLITES
  • BIOACTIVATION
  • CYSTEINE
  • METABOLIC-ACTIVATION
  • TOXICITY-DISTRIBUTION RELATIONSHIPS
  • MUTAGENICITY
  • 3-ALKYLFURANS
  • GLUTATHIONE
  • 2-METHYLFURAN

Fingerprint

Dive into the research topics of 'Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14'. Together they form a unique fingerprint.

Cite this