Scientific Opinion on Flavouring Group Evaluation 66, Revision 1 (FGE.66Rev1): Consideration of Furfuryl Alcohol and Related Flavouring Substances Evaluated by JECFA (55th meeting)

Flavourings,

doi:10.2903/j.efsa.2011.2314

Cited by 7 publications

(4 citation statements)

References 53 publications

(40 reference statements)

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“…All eight additional substances are in subgroup VI-B: seven of these 13.066,3.070,13.083,13.101,13.105,and 13.163] were from the original JECFA group of 40 and one substance, 2-benzofurancarboxaldehyde .031], was moved over from FGE.66Rev1 because this substance is structurally more similar to the candidate flavouring substance ] in subgroup V-B of FGE.67 than to the other substances in FGE.66Rev1 (EFSA CEF Panel, 2011b).…”

Section: 3mentioning

confidence: 99%

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

Flavourings¹,

Younes²,

Aquilina³

et al. 2021

EFS2

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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.

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Section: 3mentioning

confidence: 99%

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

Flavourings¹,

Younes²,

Aquilina³

et al. 2021

EFS2

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“…Contrary to the JECFA (JECFA, 2009a) and in line with the decisions taken in previous FGEs (FGE.13.Rev2, FGE.66Rev1, FGE.67;(EFSA CEF Panel, 2011c;EFSA CEF Panel, 2011b;EFSA CEF Panel, 2010b), the Panel considers that the remaining 10 substances 13.021,13.022,13.023,13.024,13.047,13.058,13.074,13.116 and 13.190] can be evaluated using the Procedure.…”

Section: Efsa Considerationsmentioning

confidence: 99%

“…Summary of Safety Evaluation of 15 JECFA-Evaluated Furfuryl Derivatives considered in FGE.66Rev1(EFSA CEF Panel, 2011b) …”

mentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 67 Revision 2 (FGE.67Rev2): Consideration of 28 furan‐substituted compounds evaluated by JECFA at the 55th, 65th and 69th meetings (JECFA, 2001, 2006a, 2009b)

Flavourings¹

2015

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The 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 present consideration concerns a group of 28 furan-substituted compounds evaluated by the JECFA. This revision of FGE.67 is due to new data on toxicity for 3-(-methyl-2-furyl) butanal .058] providing an appropriate NOAEL for the evaluation of candidate substance ]. The Panel concluded that 11 substances [FLnos: 13.006, 13.021, 13.022, 13.023, 13.024, 13.031, 13.047, 13.058, 13.074, 13.116 and 13.190] do not give rise to safety concerns at the levels of dietary intake, estimated on the basis of the MSDI approach. However, based on mTAMDI calculations, for these eleven candidate substances, except .058], more reliable intake data are required for a re-evaluation. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered, which for all candidate substances are adequate. For 17 substances 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] a concern for genotoxicity was raised and therefore these were not evaluated using the Procedure. The Panel noted further that for 7 of these 17 substances 13.052, 13.054, 13.059, 13.061, 13.069 The 28 candidate substances considered in this FGE 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.052, 13.054, 13.058, 13.059, 13.061, 13.066, 13.069, 13.070, 13.074, 13.083, 13.101, 13.103, 13.105, 13.106, 13.116, 13.123, 13.138, 13.148, 13.163 and 13.190] have been allocated to various subgroups, based on their chemical structures. These substances are structurally related to the group of 27 furfuryl and furan derivatives evaluated by EFSA in FGE.13Rev2. Part of the substances is also structurally related to a group of 33 sulphur-substituted furan derivatives used as flavouring agents, evaluated by EFSA in FGE.65Rev1 and another part is structurally related to 14 furfuryl derivatives evaluated in FGE.66Rev1.The Panel agrees with the JECFA for 17 of the substances 13.052, 13.054, 13.059, 13.061, 13.066, 13.069, 13.070, 13.083, 13.101, 13.103, 13.105, 13.106, 13.123, 13.138, 13.148 and 13.163] that these substances cannot be evaluated through the Procedure, based on concerns with respect to genotoxicity.On the basis of the new data on toxicity for 3-(5-methyl-2-furyl) butanal .058] an appropriate NOAEL of 5.9mg/kg bw per day was derived, supporting the evaluation of this candidate...

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“…The safety for the consumer of the compounds under assessment in CG 14 used as food flavours has already been assessed by JECFA (WHO, 2001(WHO, , 2002 and EFSA (EFSA CEF Panel 2010b, 2011b Given the low use levels of CG 14 compounds to be applied in feed, and the expected metabolism and excretion in target animals (see Section 3.3.1), the FEEDAP Panel considers that the possible residues in food derived from animals fed with these flavourings would not appreciably increase the human intake levels of these compounds.…”

Section: Safety For the Consumermentioning

confidence: 99%

Safety and efficacy of furfuryl and furan derivatives belonging to chemical group 14 when used as flavourings for all animal species and categories

2016

EFS2

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 18 compounds belonging to chemical group 14 (furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms). They are currently authorised as flavours in food. This opinion concerns 13 compounds from this group. The FEEDAP Panel concludes that all compounds except 5-methylfurfural are safe at the proposed maximum use level for all animal species: furfural and furfuryl alcohol at 5 mg/kg complete feed; methyl 2-furoate and furfuryl acetate at 0.5 mg/kg complete feed; bis-(2-methyl-3-furyl) disulfide, furanmethanethiol, S-furfuryl acetothioate, difurfuryl disulfide, methyl furfuryl sulfide, 2-methylfuran-3-thiol, methyl furfuryl disulfide and methyl 2-methyl-3-furyl disulfide at 0.05 mg/kg complete feed. 5-Methylfurfural is safe at the proposed use level of 0.5 mg/kg complete feed for cattle, salmonids and non-food producing animals and at the use level of 0.3 mg/kg complete feed for pigs and poultry. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and freshwater environments. Since all the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. In the absence of data on the stability in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

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Scientific Opinion on Flavouring Group Evaluation 66, Revision 1 (FGE.66Rev1): Consideration of Furfuryl Alcohol and Related Flavouring Substances Evaluated by JECFA (55th meeting)

Cited by 7 publications

References 53 publications

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

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

Scientific Opinion on Flavouring Group Evaluation 67 Revision 2 (FGE.67Rev2): Consideration of 28 furan‐substituted compounds evaluated by JECFA at the 55th, 65th and 69th meetings (JECFA, 2001, 2006a, 2009b)

Safety and efficacy of furfuryl and furan derivatives belonging to chemical group 14 when used as flavourings for all animal species and categories

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