Scientific Opinion on Flavouring Group Evaluation 217, Revision 1 (FGE.217Rev1). Consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: Lactones

Flavourings,

doi:10.2903/j.efsa.2013.3304

Cited by 3 publications

(7 citation statements)

References 7 publications

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“…The six substances belonging to CG 13 have been previously assessed by JECFA (WHO, 1999a,b) and EFSA (2008b;2009a, b;EFSA CEF Panel 2011, 2013 (EFSA, 2009b). The EFSA CEF Panel has subsequently delivered an opinion in which these two substances were considered not to give rise to concern with respect to genotoxicity and could accordingly be evaluated using the Procedure (EFSA, CEF Panel 2013).…”

Section: Discussionmentioning

confidence: 99%

“…The six substances belonging to CG 13 have been previously assessed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (WHO, 1999a, b) and EFSA (2008bEFSA ( , 2009aEFSA CEF Panel, 2011, 2013 (EFSA, 2009b;EFSA CEF Panel, 2013). Since these two substances were considered not to give rise to concern with respect to genotoxicity, they can be evaluated using the Procedure.…”

Section: Introductionmentioning

confidence: 99%

“…The six substances belonging to CG 13 have been previously assessed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (WHO, 1999a, b) and EFSA (2008bEFSA ( , 2009aEFSA CEF Panel, 2011, 2013 (EFSA, 2009b). The EFSA CEF Panel has subsequently delivered an opinion in which the genotoxicity concern for these two substances has been ruled out (EFSA CEF Panel, 2013).…”

Section: Introductionmentioning

confidence: 99%

“…No acceptable daily intake (ADI) values were specified. The CEF Panel considered the same compounds for use as food flavourings (EFSA, 2009b;EFSA CEF Panel, 2013). Since these two substances were considered not to give rise to concern with respect to genotoxicity, they can be evaluated using the Procedure.…”

Section: Introductionmentioning

confidence: 99%

“…The six substances belonging to CG 13 have been previously assessed by JECFA (WHO, 1999a,b) andEFSA (2008b;2009a, b;EFSA CEF Panel 2011, 2013 (EFSA 2008a;EFSA CEF Panel, 2011). The other two compounds belonging to CG 13, 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one [10.023] and 3-hydroxy-4,5-dimethylfuran-2(5H)-one [10.030] were excluded from the assessment based on an outstanding issue with regards to possible genotoxicity (EFSA, 2009b).…”

mentioning

confidence: 99%

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Scientific Opinion on the safety and efficacy of furanones and tetrahydrofurfuryl derivatives: 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one and 3‐hydroxy‐4, 5‐dimethylfuran‐2(5H)‐one (chemical group 13) when used as flavourings for all animal species

Högstrand¹

2014

EFS2

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European Food Safety Authority (EFSA), Parma, Italy ABSTRACT5-Ethyl-3-hydroxy-4-methylfuran-2(5H)-one and 3-hydroxy-4,5-dimethylfuran-2(5H)-one belong to chemical group 13 (furanones and tetrahydrofurfuryl derivatives) and are authorised for use as flavours in food. These additives are safe at concentrations of 0.05 mg/kg feed for poultry and pigs and 0.08 mg/kg feed for cattle, salmonids and non food-producing animals. The concentration of the additives should be appropriately reduced if used in water for drinking. If used simultaneously in feed and water for drinking, the total intake should not exceed the maximum dose resulting from the use of the flavourings in feed alone. At the levels safe for target animal species these products are safe for the consumers of animal products. The FEEDAP Panel considers it prudent to treat the compounds under assessment as irritant to skin, eyes and the respiratory tract and as skin sensitisers. The proposed concentration of 0.08 mg flavouring compound/kg feed is unlikely to have detrimental effects on the environment except when used in feed for fish in sea cages, in which case the safe concentration would be 0.047 mg/kg. Since both compounds 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. SUMMARYFollowing a request from the European Commission, the 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 5-ethyl-3-hydroxy-4-methylfuran-2(5H)-one and 3-hydroxy-4,5-dimethylfuran-2(5H)-one (furanones and tetrahydrofurfuryl derivatives belonging to chemical group 13) when used as flavours for all animal species. These two additives are currently listed in the European Union database of flavouring substances and are authorised for use as flavours in food.These additives are safe at concentrations of 0.05 mg/kg feed for poultry and pigs and 0.08 mg/kg feed for cattle, salmonids and non-food-producing animals. The concentrations of the additives should be appropriately reduced if used in water for drinking. If used simultaneously in feed and water for drinking, the total intake should not exceed the maximum dose resulting from the use of the flavourings in feed alone.At the levels safe for target animal species these products are safe for the consumers of animal products.The FEEDAP Panel considers it prudent to treat the compounds under assessment as irritant to skin, eyes and the respiratory tract and as skin sensitisers.The proposed concentration of 0.08 mg flavouring compound/kg feed is unlikely to have detrimental effects on the environment except when used in feed for fish in sea cages, in which case the safe concentration would be 0.047 mg/kg.Since both compounds 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.Furanones and tetrahydrofurfuryl derivatives (CG 13) for all species EF...

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…The six substances belonging to CG 13 have been previously assessed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (WHO, 1999a, b) and EFSA (2008bEFSA ( , 2009aEFSA CEF Panel, 2011, 2013 (EFSA, 2009b). The EFSA CEF Panel has subsequently delivered an opinion in which the genotoxicity concern for these two substances has been ruled out (EFSA CEF Panel, 2013).…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Scientific Opinion on the safety and efficacy of furanones and tetrahydrofurfuryl derivatives: 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one and 3‐hydroxy‐4, 5‐dimethylfuran‐2(5H)‐one (chemical group 13) when used as flavourings for all animal species

Högstrand¹

2014

EFS2

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Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Flavourings¹,

Younes²,

Aquilina³

et al. 2019

EFS2

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The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.024] and 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL‐no: 07.024] and [FL‐no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL‐no: 07.024] and for the structurally related substances 4‐phenylbut‐3‐en‐2‐ol [FL‐no: 02.066] and 3‐methyl‐4‐phenylbut‐3‐en‐2‐one [FL‐no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030], the Panel concluded that [FL‐no: 07.030] is aneugenic in vitro. For such substances, there is currently no agreed follow‐up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1‐(4‐methoxyphenyl)pent‐1‐en‐3‐one [FL‐no: 07.030] and the structurally related substances vanillylidene acetone [FL‐no: 07.046] and 1‐(4‐methoxyphenyl)‐4‐methylpent‐1‐en‐3‐one [FL‐no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4‐(2,3,6‐trimethylphenyl)but‐3‐en‐2‐one [FL‐no: 07.206] is to be considered as a stand‐alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL‐no: 07.206]. Industry communicated that the evaluation of [FL‐no: 07.206] is not supported any longer, therefore additional data were not submitted.

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Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Younes¹,

Aquilina²,

Castle³

et al. 2023

EFS2

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The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of four flavouring substances [FL‐no: 10.023, 10.030, 10.057 and 13.012] from subgroup 4.1 of FGE.19. For three of these substances [FL‐no: 10.023, 10.030 and 13.012], the concern for genotoxicity has been ruled out in previous revisions of Flavouring Group Evaluation 217 (FGE.217). However, in FGE.217Rev2, a concern for genotoxicity could not be ruled out for 3a,4,5,7a‐tetrahydro‐3,6‐dimethylbenzofuran‐2(3H)‐one [FL‐no: 10.057]. After publication of FGE.217Rev2, industry provided additional genotoxicity studies for [FL‐no: 10.057], which are evaluated in the present opinion FGE.217Rev3. The flavouring substance [FL‐no: 10.057] did not induce gene mutations or numerical or structural chromosomal aberrations in vitro. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for [FL‐no: 10.057]. Consequently, it can be evaluated through the Procedure.

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Scientific Opinion on Flavouring Group Evaluation 217, Revision 1 (FGE.217Rev1). Consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: Lactones

Cited by 3 publications

References 7 publications

Scientific Opinion on the safety and efficacy of furanones and tetrahydrofurfuryl derivatives: 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one and 3‐hydroxy‐4, 5‐dimethylfuran‐2(5H)‐one (chemical group 13) when used as flavourings for all animal species

Scientific Opinion on the safety and efficacy of furanones and tetrahydrofurfuryl derivatives: 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one and 3‐hydroxy‐4, 5‐dimethylfuran‐2(5H)‐one (chemical group 13) when used as flavourings for all animal species

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Flavouring Group Evaluation 217 Revision 3 (FGE.217Rev3): consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

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