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

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.

Occurrence of Perillaldehyde and Other (Suspected) Genotoxic Flavoring Substances in Water-Based Beverages Consumed by Belgian Children

“…Fewer occurrences and lower levels were reported for 2,4-pentanedione (up to 20 μg·kg –1 ), 2-acetyl-3,5-dimethylfuran (up to 2 μg·kg –1 ), menthalactone (9 μg·kg –1 ), and 4-methyl-5-vinylthiazole (up to 15 μg·kg –1 ). Among these compounds, as indicated in Table , the genotoxic concern for 2-acetylfuran and 2-acetyl-3,5-dimethylfuran was ruled out within the time frame of this work . Menthalactone was instead no longer authorized to be added to food as industry discontinued its use.…”

“…In total, 38 compounds were selected for analysis and are listed in Table 1 with their current safety evaluation status. Except for ethone (20) and homo ethone (22), all selected compounds have already been identified in nature. 17−19 3.2.…”

“…Among these compounds, as indicated in Table 1, the genotoxic concern for 2-acetylfuran and 2-acetyl-3,5-dimethylfuran was ruled out within the time frame of this work. 20 Menthalactone was instead no longer authorized to be added to food as industry discontinued its use. This stopped its safety evaluation and led to its removal from the Union list.…”

A Proposal for Evaluating the Economic Viability of Biorefineries against Petrochemical Benchmarks

“…Furthermore, HMF can be used as a food additive and is known as a flavoring agent under FL-No. 13.139 [34]. The promising fuel additive 2,5-dimethylfuran (DMF) can be HMF-based.…”

Safety and efficacy of a feed additive consisting of an essential oil derived from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson (lemongrass oil) for use in all animal species (FEFANA asbl)

“…Toxicological data of subchronic studies, from which NOAEL values could be derived, were available for acetaldehyde [05.001] the representative compound in CG 1 (EFSA FEEDAP Panel, 2013 ), citral [05.020] the representative compound in CG 3 (EFSA FEEDAP Panel, 2016a ), citronellol [02.011], hex‐3(cis)‐en‐1‐ol [02.056] and 2,6‐dimethylhept‐5‐enal [05.074] in CG 4 (EFSA FEEDAP Panel, 2016b ), for heptan‐2‐one [07.002] and 6‐methylhept‐5‐en‐2‐one [07.015] in CG 5 (EFSA FEEDAP Panel, 2015a ), terpineol [02.230] 28 and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2012a ), menthol [02.015] in CG 8 (EFSA FEEDAP Panel, 2016c ), isoeugenol [04.004] in CG 17 (EFSA FEEDAP Panel, 2012d ), myrcene [01.008], d‐limonene [01.045], p‐cymene [01.002] and β‐caryophyllene in CG 31 (EFSA FEEDAP, 2015b , 2016d ), and β‐caryophyllene epoxide [16.043] for CG 32 (EFSA CEF Panel, 2014 ). For d‐carvone [01.146] and 2‐pentylfuran [13.059], not present in the essential oil but structurally related to some components, the applicant made reference to a BMD lower confidence limit for a benchmark response of 10% (BMDL 10 ) of 60 mg/kg bw per day (EFSA SC, 2014 ; EFSA FEEDAP Panel, 2016c ) and of 8.52 mg/kg bw per day (EFSA FAF Panel, 2021a , b ), respectively.…”