Safety and efficacy of aromatic ketones, secondary alcohols and related esters belonging to chemical group 21 when used as flavourings for all animal species

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doi:10.2903/j.efsa.2016.4557

Cited by 4 publications

(3 citation statements)

References 31 publications

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“…However, the lack of data on metabolism and residues in poultry precluded an assessment of consumer exposure from this source (EFSA FEEDAP Panel, 2011 ). Subsequently, the FEEDAP Panel reviewed the literature available on the enzymes involved in the biotransformation of several classes of compounds and found that both Phase I (CYP450 monooxygenase families, epoxide hydrolases) and Phase II enzymes (glucuronide‐ sulfate‐ and glutathione‐transferases) are also expressed in birds (EFSA FEEDAP Panel, 2013b , 2016b , c ). Therefore, birds can also be assumed to have the ability to metabolise and excrete trans ‐anethole as mammals and there is no evidence that they or their metabolites would accumulate in tissues and cause a concern for consumer safety.…”

Section: Assessmentmentioning

confidence: 99%

“…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, 2013a ), 2‐ethylhexan‐1‐ol [02.082] the representative compound in CG 2 (EFSA FEEDAP Panel, 2012a ), linalool [02.013] and terpineol 33 [02.230] in CG 6 (EFSA FEEDAP Panel, 2012b ), carvone in CG 8 (EFSA SC, 2014 ), trans ‐anethole [04.010] in CG 18 (EFSA FEEDAP Panel, 2011 ), 4‐(4‐hydroxyphenyl)butan‐2‐one [07.055] in CG 21 (EFSA FEEDAP Panel, 2016c ), anisaldehyde [05.015] in CG 23 (EFSA FEEDAP Panel, 2012c ), methyl isoeugenol [04.013] in CG 26 (EFSA FEEDAP Panel, 2012d ), myrcene [01.008], d‐limonene [01.045], p‐cymene [01.002] and β‐caryophyllene [01.007] in CG 31 (EFSA FEEDAP Panel, 2015 , 2016b ).…”

Section: Assessmentmentioning

confidence: 99%

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Safety and efficacy of feed additives obtained from the fruit of Pimpinella anisum L.: anise oil for use in poultry and horses and anise tincture for use in poultry, dogs, cats and horses (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

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 anise oil and anise tincture obtained from the fruit of Pimpinella anisum L., when used as sensory additives. The use of the anise oil at the proposed use level in complete feed of 1.9 mg/kg for laying hens and 5 mg/kg for horses was considered of low concern. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concern when anise oil is used at the proposed use levels of 1.5 mg/kg for chickens for fattening and at 1.7 mg/kg for turkeys for fattening. The use of anise tincture at the proposed conditions of use was considered of low concern in dogs, cats, horses and laying hens, and of no concern in chickens for fattening. The use of the additives up to the highest level in feed which was considered of low or no concern for target animals was also expected to be of no concern for consumers. The additives under assessment should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. Due to the high concentration of estragole (≥ 1%), anise oil is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. When handling anise tincture, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of these additives in animal feed was not expected to pose a risk to the environment. Since the fruit of P. anisum and its preparations are recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was considered necessary.

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Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of feed additives obtained from the fruit of Pimpinella anisum L.: anise oil for use in poultry and horses and anise tincture for use in poultry, dogs, cats and horses (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

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“…The initial application on CG 21 concerned 10 compounds, intended to be used as feed flavourings for all animal species. The European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has already delivered an opinion on eight of the 10 compounds included in CG 21 (EFSA FEEDAP Panel, 2016).…”

Section: Additional Informationmentioning

confidence: 99%

Safety and efficacy of 4‐phenylbut‐3‐en‐2‐one and benzophenone belonging to chemical group 21 when used as flavouring compounds for all animal species

Additives¹,

Bampidis²,

Azimonti³

et al. 2020

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 4‐phenylbut‐3‐en‐2‐one [07.024] and benzophenone [07.032] belonging to chemical group 21, when used as feed flavourings for all animal species. They are currently authorised for use as flavours in food. The use of 4‐phenyl‐3‐butene‐2‐one [07.024] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. Benzophenone [07.032] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species except chicken for fattening, laying hens and piglets, for which the calculated safe concentration in feed is 0.5 mg/kg. No safety concern would arise for the consumer from the use of 4‐phenyl‐3‐butene‐2‐one [07.024] and benzophenone [07.032] as feed flavourings. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for users when handling the additives. The use of 4‐phenyl‐3‐butene‐2‐one [07.024] and benzophenone [07.032] in animal feed at the maximum safe use level in feed is also considered safe for the environment. Since 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.

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Safety of 31 flavouring compounds belonging to different chemical groups when used as feed additives for all animal species

Additives¹,

Bampidis²,

Azimonti³

et al. 2020

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 of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty‐two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The FEEDAP Panel concluded that the 22 compounds are safe for these species at the proposed use level and conclusions were extrapolated to all animal species for all the compounds except for α‐damascone [07.134]. In the absence of data that would allow the FEEDAP Panel to rule out the genotoxicity concern, the FEEDAP Panel cannot extend the conclusions for α‐damascone [07.134] to all animal species and cannot conclude on the safety for the consumer, the user and the environment. No safety concern would arise for the consumer from the use of the remaining 30 compounds up to the highest levels considered safe for target animals. The revised maximum safe levels for the 30 compounds are not expected to further impact on the previous conclusions on user safety. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds except β‐damascone [07.083] and (E)‐β‐damascone [07.224], for which in the absence of ecotoxicity data, the FEEDAP Panel cannot conclude on the safety for the terrestrial compartments. For the marine environment, the safe use level for 2‐methyl‐1‐phenylpropan‐2‐ol [02.035], α‐irone [07.011], β‐damascone [07.083] and (E)‐β‐damascone [07.224], phenethyl isovalerate [09.466], 4‐(p‐hydroxyphenyl) butan‐2‐one [07.055] and 2‐isopropyl‐4‐methylthiazole [15.026] is confirmed to be 0.05 mg/kg.

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Safety and efficacy of aromatic ketones, secondary alcohols and related esters belonging to chemical group 21 when used as flavourings for all animal species

Cited by 4 publications

References 31 publications

Safety and efficacy of feed additives obtained from the fruit of Pimpinella anisum L.: anise oil for use in poultry and horses and anise tincture for use in poultry, dogs, cats and horses (FEFANA asbl)

Safety and efficacy of feed additives obtained from the fruit of Pimpinella anisum L.: anise oil for use in poultry and horses and anise tincture for use in poultry, dogs, cats and horses (FEFANA asbl)

Safety and efficacy of 4‐phenylbut‐3‐en‐2‐one and benzophenone belonging to chemical group 21 when used as flavouring compounds for all animal species

Safety of 31 flavouring compounds belonging to different chemical groups when used as feed additives for all animal species

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