Scientific Opinion on Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8

Flavourings,

doi:10.2903/j.efsa.2015.4118

Cited by 9 publications

(9 citation statements)

References 60 publications

(73 reference statements)

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“…For these compounds, for which there is no concern for genotoxicity, EFSA requested additional toxicity data (EFSA CEF Panel, 2011b ). In the absence of such toxicological data, the EFSA CEF Panel was unable to complete its assessment (EFSA CEF Panel, 2015 b). As a result, these compounds are not authorised for use as flavours in food.…”

Section: Assessmentmentioning

confidence: 99%

“… (f) Evaluated applying the ‘Procedure’ described in the Guidance on the data required for the risk assessment of flavourings to be used in or on food (EFSA CEF Panel, 2010 ). No longer authorised for use as flavours in food, as the additional toxicity data requested (EFSA CEF Panel, 2011b ) were not submitted and the CEF Panel was unable to complete its assessment (EFSA CEF Panel, 2015 b). …”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of a feed additive consisting of an essential oil derived from the fruit of Illicium verum Hook.f. (star anise oil) for use in all animal species (FEFANA asbl)

Bampidis,

Azimonti,

Bastos

et al. 2023

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of star anise oil from the fruit (without or with the presence of plant leaves) of Illicium verum Hook.f., when used as a sensory additive in feed and water for drinking for all animal species. For long‐living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of the additive in complete feed at 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.6 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 6.5 mg/kg for ornamental fish. For short‐living animals, the Panel had no safety concern when the additive is used at 83.3 mg/kg for veal calves, 73.3 mg/kg for sheep/goats, cattle for fattening and horses for meat production, 83.8 mg/kg for salmonids, 24.8 mg/kg for turkeys for fattening, 18.5 mg/kg chickens for fattening, 33.3 mg/kg for piglets, 40 mg/kg for pigs for fattening and 29.3 mg/kg for rabbits for meat production. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered of low concern at 0.6 mg/kg. The use of star anise oil in animal feed is expected to be of no concern for consumers and for the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Due to the high concentration of estragole (≥ 1%), the additive is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of I. verum and its preparations are recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was necessary.

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Section: Assessmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of an essential oil derived from the fruit of Illicium verum Hook.f. (star anise oil) for use in all animal species (FEFANA asbl)

Bampidis,

Azimonti,

Bastos

et al. 2023

EFS2

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“…Based on considerations related to structural and metabolic similarities, the components were allocated to 12 assessment groups, corresponding to the chemical groups (CGs) 2, 6, 8, 13, 15, 16, 18, 21, 22, 23, 31 and 32, as defined in Annex I of Regulation (EC) No 1565/2000. For chemical group 31 (‘aliphatic and aromatic hydrocarbons’), the application of sub‐assessment groups as defined in Flavouring Group Evaluation 25 (FGE.25) and FGE.78 is applied (EFSA CEF Panel, 2015a , b ). The allocation of the components to the (sub‐)assessment groups is shown in Table 4 and in the corresponding footnote.…”

Section: Assessmentmentioning

confidence: 99%

“…The NOAELs for the representative compounds of CG 31, myrcene [01.008], limonene [01.001] and β‐caryophyllene [01.007] were applied, respectively, using read‐across to the compounds within sub‐assessment groups II, III and V, respectively (EFSA CEF Panel, 2015a , 2015b ).…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of feed additives consisting of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil) for use in all animal species (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

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 essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil), when used as sensory additives (flavourings) in feed and water for drinking for all animal species. Owing to the presence of styrene in the essential oils under assessment, the FEEDAP Panel is not in the position to conclude on the safety for long‐living animals and animals for reproduction. For ‘short‐living’ animals, the FEEDAP Panel concluded that cinnamon bark oil and cinnamon leaf oil are considered as safe up to the maximum proposed use levels in complete feed. For ‘short‐living’ animals, the Panel considered the use of cinnamon bark oil in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. For cinnamon leaf oil, the proposed use level in water for drinking of 3 mg/L is considered as safe for ‘short‐living’ animals. No concerns for consumers were identified following the use of the additives at the use level considered safe in feed for the target species. Based on the presence of safrole ≥0.1%, cinnamon leaf oil and bark oil are classified as carcinogen (category 1B) and handled accordingly. The use of the additives under the proposed conditions in animal feed was not expected to pose a risk for the environment. Since C. verum and its preparations are recognised to flavour food and its function in feed would be essentially the same, no further demonstration of efficacy is considered necessary for cinnamon essential oils.

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“…The specification for terpineol [02.230] covers α‐, β‐, γ and δ‐terpineol. Composition of mixture: 55–75% α‐terpineol, 16–23% γ‐terpineol, 1–10% cis‐β‐terpineol, 1–13% trans ‐β‐terpineol and 0–1% δ‐terpineol (EFSA CEF Panel, 2015c ).…”

Section: Notesmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of an essential oil from the fruit of Cuminum cyminum L. (cumin oil) for use in all animal species (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of Cuminum cyminum L. (cumin oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of cumin oil up to the maximum proposed use levels in feed of 15 mg/kg complete feed is considered as safe for all animal species. The FEEDAP Panel considered the use in water for drinking as safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of cumin oil up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the essential oil, exposure of unprotected users to estragole (and dillapiole) cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of cumin oil at the proposed use level in feed is not expected to pose a risk to the environment. Since C. cyminum and its preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

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Scientific Opinion on Flavouring Group Evaluation 18, Revision 3 (FGE.18Rev3): Aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols, aromatic tertiary alcohols and their esters from chemical groups 6 and 8

Cited by 9 publications

References 60 publications

Safety and efficacy of a feed additive consisting of an essential oil derived from the fruit of Illicium verum Hook.f. (star anise oil) for use in all animal species (FEFANA asbl)

Safety and efficacy of a feed additive consisting of an essential oil derived from the fruit of Illicium verum Hook.f. (star anise oil) for use in all animal species (FEFANA asbl)

Safety and efficacy of feed additives consisting of essential oils from the bark and the leaves of Cinnamomum verum J. Presl (cinnamon bark oil and cinnamon leaf oil) for use in all animal species (FEFANA asbl)

Safety and efficacy of a feed additive consisting of an essential oil from the fruit of Cuminum cyminum L. (cumin oil) for use in all animal species (FEFANA asbl)

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