Search

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh flowering tops of Lavandula angustifolia Mill. (lavender oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum proposed use levels in complete feed of 30 mg/kg for dogs and ornamental fish. For the other target species, the calculated safe concentrations were 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 19 mg/kg for pigs for fattening, 16 mg/kg for piglets, 23 mg/kg for sows, 39 mg/kg for veal calves (milk replacer) and salmonids, 35 mg/kg for cattle for fattening, sheep/goats and horses, 22 mg/kg for dairy cows, 14 mg/kg for rabbits and 7 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 7 mg/kg complete feed. The use of lavender oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. The use of lavender oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering tops of L. angustifolia is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Spanish sage oil from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of Spanish sage oil in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of Spanish sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis ssp. lavandulifolia (Vahl) Gams is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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 Apium graveolens L. (celery seed 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) Panel concluded that the use of celery seed oil is of no concern up to the following concentrations in complete feed: 1.6 mg/kg for chickens for fattening, 2.3 mg/kg for laying hens, 2.1 mg/kg for turkeys for fattening, 2.8 mg/kg for piglets, 3.3 mg/kg for pigs for fattening, 4.1 mg/kg for sows, 6.5 mg/kg for veal calves (milk replacer), 6.2 mg/kg for cattle for fattening, sheep, goats and horses, 4.0 mg/kg for dairy cows, 2.5 mg/kg for rabbits, 6.8 mg/kg for salmonids and 7.2 mg/kg for dogs. These conclusions were extrapolated to other physiologically related species. For cats, ornamental fish and other species, no conclusion can be drawn. The use of celery seed oil in animals feed is not expected to pose concern for the consumers and for the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a respiratory and skin sensitiser. When handling the essential oil, exposure of unprotected users to perillaldehyde and bergapten may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since A. graveolens and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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 Carum carvi L. (caraway 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) Panel concluded that the use of caraway oil is of no concern up to the following concentrations in complete feed: 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 16 mg/kg for piglets, 19 mg/kg for pigs for fattening, 24 mg/kg for sows, 35 mg/kg for veal calves (milk replacer), 11 mg/kg for cattle for fattening, 10 mg/kg for dairy cows, sheep, goats, horses and rabbits, 25 mg/kg for salmonids and dogs. These conclusions were extrapolated to other physiologically related species. For cats, ornamental fish and other species, no conclusion can be drawn. The use of caraway oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a respiratory and skin sensitiser. When handling the essential oil, exposure of unprotected users to perillaldehyde may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since C. carvi and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tea tree oil obtained from leaves and terminal branchlets of Melaleuca alternifolia (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long‐living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.5 mg/kg for turkeys for fattening, 1.7 mg/kg for laying hens, 2.0 mg/kg for piglets, 2.4 mg/kg for pigs for fattening, 3.1 mg/kg for sows, 5.0 mg/kg for veal calves (milk replacer) and salmonids, 4.4 mg/kg for cattle for fattening, sheep/goats and horses, 2.9 mg/kg for dairy cows, 1.8 mg/kg for rabbits, 0.9 mg/kg for cats, 5.3 mg/kg for dogs, 6.6 for crustaceans and 15 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is very unlikely to be of safety concern at 1.1 mg/kg complete feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. Regarding user safety, tea tree oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. It is classified as a reprotoxic substance (category 1B) following CLP criteria and should be handled accordingly. Since M. alternifolia and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Spanish sage oil from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of Spanish sage oil in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of Spanish sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis ssp. lavandulifolia (Vahl) Gams is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh flowering tops of Lavandula angustifolia Mill. (lavender oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum proposed use levels in complete feed of 30 mg/kg for dogs and ornamental fish. For the other target species, the calculated safe concentrations were 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 19 mg/kg for pigs for fattening, 16 mg/kg for piglets, 23 mg/kg for sows, 39 mg/kg for veal calves (milk replacer) and salmonids, 35 mg/kg for cattle for fattening, sheep/goats and horses, 22 mg/kg for dairy cows, 14 mg/kg for rabbits and 7 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 7 mg/kg complete feed. The use of lavender oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. The use of lavender oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering tops of L. angustifolia is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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 wood of Juniperus deppeana Steud. (cedarwood Texas oil), when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered 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 and the environment were identified following the use of the additive 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 skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) when used as a sensory additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of ~ 1.86%, which contains on average 0.454% phenolic acids and flavonoids (of which 0.280% was gallic acid), 0.0030% 1,8‐cineole and 0.00012% methyleugenol. In the absence of analytical data on the occurrence of mono‐ or diformylated adducts of acylphloroglucinols with terpenes in the tincture and in the absence of toxicity data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the use of eucalyptus tincture for long‐living and reproductive animals. For short‐living animals (species for fattening), the additive was considered of no concern at 4 mg/kg complete feed for chickens for fattening, 5 mg/kg for turkeys for fattening, 6 mg/kg for piglets and rabbits for meat production, 7 mg/kg for pigs for fattening, 16 mg/kg for veal calves (milk replacer), 14 mg/kg for cattle for fattening, sheep/goats and horses for fattening, and 15 mg/kg for salmonids. These levels were extrapolated to physiologically related minor species. No safety concern would arise for the consumer from the use of eucalyptus tincture up to the levels in feed considered of no concern. Eucalyptus tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of eucalyptus tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the leaves of E. globulus and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■) solution, with a dry matter content of ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels 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 additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of S. aromaticum and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long‐living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short‐living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Panax ginseng C.A.Mey. (ginseng tincture), when used as a sensory additive in feed for horses, dogs and cats. The product is a water/ethanol (40:60 v/v) solution, with a dry matter content of no more than 6% and a content of 0.01%–0.5% (w/w) for the sum of the two triterpene saponins ginsenoside Rb1 and ginsenoside Rg1. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the tincture is safe for horses, dogs and cats at the maximum proposed use level of 48.6, 228.7 and 162 mg/kg complete feed, respectively. The Panel also concluded that the additive is considered safe for consumers when used at the proposed conditions of use in feed for horses. Ginseng tincture should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the ginseng tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the roots of P. ginseng and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive obtained from the dried leaves of Ginkgo biloba L. (ginkgo extract) when used as a sensory additive in feed for horses, dogs, cats, rabbits and guinea pigs. Ginkgo extract contains ≥ 24% total flavonoids, ≥ 6% total terpene lactones and ≤ 1 mg/kg ginkgolic acids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ginkgo extract is safe for the target species at the following concentrations in complete feed: 2.8 mg/kg for horses and cats, 1.1 mg/kg for rabbits and guinea pigs, and 3.3 mg/kg for dogs. No safety concern would arise for the consumers from the use of ginkgo extract up to the highest level in feed which is considered safe for food‐producing species (horses and rabbits). The additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the additive at the proposed level in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that the ginkgo extract would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additive. [ABSTRACT FROM AUTHOR]

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 cajuput oil obtained from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., when used as a sensory additive for all animal species. The FEEDAP Panel concluded that cajuput oil is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for sows and dogs, 50 mg/kg for horses and ornamental fish, 40 mg/kg for salmon and 5 mg/kg for cats. For the other species, the calculated safe concentrations were 18 mg/kg for chickens for fattening, 26 mg/kg for laying hens, 23 mg/kg for turkeys for fattening, 37 mg/kg for pigs for fattening, 31 mg/kg for piglets, 78 mg/kg for veal calves (milk replacer), 69 mg/kg for cattle for fattening and sheep/goats, 45 mg/kg for dairy cows and 28 mg/kg for rabbits. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 5 mg/kg complete feed. The use of cajuput oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since cajuput oil was recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%–0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of S. chinensis can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment. [ABSTRACT FROM AUTHOR]

Abstract 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 Carum carvi L. (caraway 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) Panel concluded that the use of caraway oil is of no concern up to the following concentrations in complete feed: 9 mg/kg for chickens for fattening, 13 mg/kg for laying hens, 12 mg/kg for turkeys for fattening, 16 mg/kg for piglets, 19 mg/kg for pigs for fattening, 24 mg/kg for sows, 35 mg/kg for veal calves (milk replacer), 11 mg/kg for cattle for fattening, 10 mg/kg for dairy cows, sheep, goats, horses and rabbits, 25 mg/kg for salmonids and dogs. These conclusions were extrapolated to other physiologically related species. For cats, ornamental fish and other species, no conclusion can be drawn. The use of caraway oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a respiratory and skin sensitiser. When handling the essential oil, exposure of unprotected users to perillaldehyde may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since C. carvi and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract 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 Apium graveolens L. (celery seed 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) Panel concluded that the use of celery seed oil is of no concern up to the following concentrations in complete feed: 1.6 mg/kg for chickens for fattening, 2.3 mg/kg for laying hens, 2.1 mg/kg for turkeys for fattening, 2.8 mg/kg for piglets, 3.3 mg/kg for pigs for fattening, 4.1 mg/kg for sows, 6.5 mg/kg for veal calves (milk replacer), 6.2 mg/kg for cattle for fattening, sheep, goats and horses, 4.0 mg/kg for dairy cows, 2.5 mg/kg for rabbits, 6.8 mg/kg for salmonids and 7.2 mg/kg for dogs. These conclusions were extrapolated to other physiologically related species. For cats, ornamental fish and other species, no conclusion can be drawn. The use of celery seed oil in animals feed is not expected to pose concern for the consumers and for the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a respiratory and skin sensitiser. When handling the essential oil, exposure of unprotected users to perillaldehyde and bergapten may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since A. graveolens and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species. Nonanoic acid is currently authorised for use as a sensory additive (functional group: flavouring compounds) for all animal species at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the active substance from 5 to 100 mg/kg complete feed for all poultry and pig species. In support of the safety of the additive at the new proposed level, the applicant provided tolerance trials in the target species. The FEEDAP Panel concludes that nonanoic acid is safe for all growing poultry species and Suidae at 100 mg/kg feed. The Panel cannot conclude on the safety of the new proposed level (100 mg/kg complete feed) for laying hens, turkeys for breeding, minor poultry species for laying/breeding and reproductive Suidae. However, FEEDAP Panel considered that nonanoic acid is safe at 10 mg/kg complete feed in laying hens, turkeys for breeding, minor poultry species for laying/breeding and 20 mg/kg complete feed for reproductive Suidae. The use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for the consumer and the environment. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant neither a dermal nor respiratory sensitiser. No further demonstration of efficacy is necessary. [ABSTRACT FROM AUTHOR]

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■) solution, with a dry matter content of ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels 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 additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of S. aromaticum and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long‐living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short‐living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) when used as a sensory additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of ~ 1.86%, which contains on average 0.454% phenolic acids and flavonoids (of which 0.280% was gallic acid), 0.0030% 1,8‐cineole and 0.00012% methyleugenol. In the absence of analytical data on the occurrence of mono‐ or diformylated adducts of acylphloroglucinols with terpenes in the tincture and in the absence of toxicity data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the use of eucalyptus tincture for long‐living and reproductive animals. For short‐living animals (species for fattening), the additive was considered of no concern at 4 mg/kg complete feed for chickens for fattening, 5 mg/kg for turkeys for fattening, 6 mg/kg for piglets and rabbits for meat production, 7 mg/kg for pigs for fattening, 16 mg/kg for veal calves (milk replacer), 14 mg/kg for cattle for fattening, sheep/goats and horses for fattening, and 15 mg/kg for salmonids. These levels were extrapolated to physiologically related minor species. No safety concern would arise for the consumer from the use of eucalyptus tincture up to the levels in feed considered of no concern. Eucalyptus tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of eucalyptus tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the leaves of E. globulus and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Abstract 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 wood of Juniperus deppeana Steud. (cedarwood Texas oil), when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered 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 and the environment were identified following the use of the additive 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 skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Panax ginseng C.A.Mey. (ginseng tincture), when used as a sensory additive in feed for horses, dogs and cats. The product is a water/ethanol (40:60 v/v) solution, with a dry matter content of no more than 6% and a content of 0.01%–0.5% (w/w) for the sum of the two triterpene saponins ginsenoside Rb1 and ginsenoside Rg1. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the tincture is safe for horses, dogs and cats at the maximum proposed use level of 48.6, 228.7 and 162 mg/kg complete feed, respectively. The Panel also concluded that the additive is considered safe for consumers when used at the proposed conditions of use in feed for horses. Ginseng tincture should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the ginseng tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the roots of P. ginseng and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive obtained from the dried leaves of Ginkgo biloba L. (ginkgo extract) when used as a sensory additive in feed for horses, dogs, cats, rabbits and guinea pigs. Ginkgo extract contains ≥ 24% total flavonoids, ≥ 6% total terpene lactones and ≤ 1 mg/kg ginkgolic acids. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that ginkgo extract is safe for the target species at the following concentrations in complete feed: 2.8 mg/kg for horses and cats, 1.1 mg/kg for rabbits and guinea pigs, and 3.3 mg/kg for dogs. No safety concern would arise for the consumers from the use of ginkgo extract up to the highest level in feed which is considered safe for food‐producing species (horses and rabbits). The additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the additive at the proposed level in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that the ginkgo extract would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additive.

Abstract 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 cajuput oil obtained from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., when used as a sensory additive for all animal species. The FEEDAP Panel concluded that cajuput oil is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for sows and dogs, 50 mg/kg for horses and ornamental fish, 40 mg/kg for salmon and 5 mg/kg for cats. For the other species, the calculated safe concentrations were 18 mg/kg for chickens for fattening, 26 mg/kg for laying hens, 23 mg/kg for turkeys for fattening, 37 mg/kg for pigs for fattening, 31 mg/kg for piglets, 78 mg/kg for veal calves (milk replacer), 69 mg/kg for cattle for fattening and sheep/goats, 45 mg/kg for dairy cows and 28 mg/kg for rabbits. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 5 mg/kg complete feed. The use of cajuput oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since cajuput oil was recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%–0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of S. chinensis can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species. Nonanoic acid is currently authorised for use as a sensory additive (functional group: flavouring compounds) for all animal species at a recommended maximum content of 5 mg/kg complete feed. The applicant is requesting a modification of the authorisation to increase the recommended maximum content of the active substance from 5 to 100 mg/kg complete feed for all poultry and pig species. In support of the safety of the additive at the new proposed level, the applicant provided tolerance trials in the target species. The FEEDAP Panel concludes that nonanoic acid is safe for all growing poultry species and Suidae at 100 mg/kg feed. The Panel cannot conclude on the safety of the new proposed level (100 mg/kg complete feed) for laying hens, turkeys for breeding, minor poultry species for laying/breeding and reproductive Suidae. However, FEEDAP Panel considered that nonanoic acid is safe at 10 mg/kg complete feed in laying hens, turkeys for breeding, minor poultry species for laying/breeding and 20 mg/kg complete feed for reproductive Suidae. The use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for the consumer and the environment. Due to the lack of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant neither a dermal nor respiratory sensitiser. No further demonstration of efficacy is necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from fruit and stems of Foeniculum vulgare Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). 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 bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short‐living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. 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%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of F. vulgare Mill. ssp. vulgare and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary. [ABSTRACT FROM AUTHOR]

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 Coriandrum sativum L. (coriander oil), when used as a sensory additive in feed for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of coriander oil is safe up to the maximum proposed use levels of 30 mg/kg complete feed for piglets, pigs for fattening, sows, veal calves (milk replacer), cattle for fattening, sheep, goats and horses, salmonids, dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 14 mg/kg for chickens for fattening, 28 mg/kg for laying hens, 26 mg/kg for turkeys for fattening, 28 mg/kg for rabbits and 14 mg/kg for cats. These conclusions were extrapolated to physiologically related species. For any other species, the additive was considered safe at 14 mg/kg complete feed. The proposed conditions of use for veal calves (10 mg/kg) and ruminants, horses and dogs (5 mg/kg) were considered safe provided that the use in water for drinking alone or in combination with the use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No concerns for consumers and the environment were identified following the use of coriander oil up to the maximum proposed use level in feed. Coriander oil should be considered as irritant to skin and eyes and the respiratory tract and as a dermal and respiratory sensitiser. Since C. sativum 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 was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes), when used as a feed additive for all animal species. The additive contains up to 25% estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. This is not in line with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, the FEEDAP Panel considered it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive. [ABSTRACT FROM AUTHOR]

Abstract 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 Coriandrum sativum L. (coriander oil), when used as a sensory additive in feed for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of coriander oil is safe up to the maximum proposed use levels of 30 mg/kg complete feed for piglets, pigs for fattening, sows, veal calves (milk replacer), cattle for fattening, sheep, goats and horses, salmonids, dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 14 mg/kg for chickens for fattening, 28 mg/kg for laying hens, 26 mg/kg for turkeys for fattening, 28 mg/kg for rabbits and 14 mg/kg for cats. These conclusions were extrapolated to physiologically related species. For any other species, the additive was considered safe at 14 mg/kg complete feed. The proposed conditions of use for veal calves (10 mg/kg) and ruminants, horses and dogs (5 mg/kg) were considered safe provided that the use in water for drinking alone or in combination with the use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No concerns for consumers and the environment were identified following the use of coriander oil up to the maximum proposed use level in feed. Coriander oil should be considered as irritant to skin and eyes and the respiratory tract and as a dermal and respiratory sensitiser. Since C. sativum 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 was considered necessary.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes), when used as a feed additive for all animal species. The additive contains up to 25% estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. This is not in line with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, the FEEDAP Panel considered it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from fruit and stems of Foeniculum vulgare Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). 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 bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short‐living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. 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%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of F. vulgare Mill. ssp. vulgare and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of essential oils from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry: clove bud oil, clove leaf oil and a β‐caryophyllene‐rich fraction of clove leaf oil (CCL oil), when used as sensory additives in feed and water for drinking for all animal species. Clove oils contain methyleugenol (up to 0.13%). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove oils was of low concern for long‐living and reproductive animals and of no concern for target species for fattening at the following concentrations in complete feed: 25–50 mg/kg for clove bud oil, 28–100 mg/kg for clove leaf oil and 20 mg/kg for CCL oil. The FEEDAP Panel considered that the use in water for drinking alone or in conjunction with use in feed should not exceed the daily amount that is considered of low or no concern when consumed via feed alone. No concerns for consumers were identified following the use of clove oils up to the highest safe level in feed. The additives under assessment should be considered as irritant to skin and eyes and the respiratory tract and as skin sensitisers. When handling the essential oils, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of clove oils at the proposed use level in feed was not expected to pose a risk for the environment. Since clove bud oil and clove leaf oil are recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 lemongrass oil obtained from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson when used as a sensory additive for all animal species. The FEEDAP Panel concluded that lemongrass oil is safe up to the maximum proposed use levels in complete feed of 125 mg/kg for salmonids; 100 mg/kg for sows and horses; 75 mg/kg for veal calves (milk replacer), cattle for fattening, dairy cows, sheep and goats; and 50 mg/kg for dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 41 mg/kg for chickens for fattening, 61 mg/kg for laying hens, 55 mg/kg for turkeys for fattening, 74 mg/kg for piglets, 88 mg/kg for pigs for fattening, 65 mg/kg for rabbits and 33 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 33 mg/kg complete feed. The use of lemongrass oil in water for drinking for poultry, pigs, calves and rabbit is safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the aerial parts of C. flexuosus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the buds of Pinus sylvestris L. (pine tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product under assessment is a ■■■■■ solution, with a dry matter content of ~ 2.2%. The product contains on average 0.0882% polyphenols, of which 0.0222% are phenolic acids. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that pine tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for all animal species. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No safety concern would arise for the consumer from the use of pine tincture up to the maximum proposed use level in feed. Pine tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of pine tincture in animal feed was not expected to pose a risk for the environment. Since twigs of P. sylvestris, which are considered similar in composition to the source material for the production of pine tincture, are described to flavour food, no further demonstration of efficacy is deemed necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the leaves and twigs of Eucalyptus globulus Labill. (eucalyptus oil) when used as a sensory additive in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the use of eucalyptus oil is safe at the following concentrations in complete feed: 12 mg/kg for chickens for fattening, 18 mg/kg for laying hens, 16 mg/kg for turkeys for fattening, 22 mg/kg for piglets, 26 mg/kg for pigs for fattening, 32 mg/kg for sows, 55 mg/kg for veal calves (milk replacer), 48 mg/kg for cattle for fattening, sheep, goats and horses, 31 mg/kg for dairy cows, 19 mg/kg for rabbits, 55 mg/kg for salmonids, 58 mg/kg for dogs, 10 mg/kg for cats and 75 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 10 mg/kg complete feed. No concerns for consumers were identified following the use of eucalyptus oil up to the highest safe level in feed. The additive under assessment should be considered as irritant to skin and eyes and the respiratory tract and as a skin sensitiser. The use of eucalyptus oil at the proposed use level in feed was not expected to pose a risk for the environment. Since E. globulus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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 herbaceous parts of Pelargonium graveolens L'Hér. (geranium rose 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 geranium rose oil is safe up to the maximum proposed use levels of 5 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use in water for drinking is 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 geranium rose 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 skin and respiratory sensitiser. The use of geranium rose oil at the proposed use level in feed was not expected to pose a risk to the environment. Since P. graveolens and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the seeds of Myristica fragrans Houtt. (nutmeg oil), when used as a sensory additive in feed and water for drinking for all animal species. The additive contains myristicin (up to 12%), safrole (2.30%), elemicin (0.40%) and methyleugenol (0.33%). 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 0.2 mg/kg for laying hens and rabbits, 0.3 mg/kg for sows and dairy cows, 0.5 mg/kg for sheep/goats, horses and cats, 0.6 mg/kg for dogs and 2.5 mg/kg for ornamental fish. For short‐living animals, the Panel had no safety concern when the additive is used at the maximum proposed use level of 10 mg/kg for veal calves, cattle for fattening, sheep/goats, horses for meat production, and salmon and for the other species, at 3.3 mg/kg for turkeys for fattening, 2.8 mg/kg chickens for fattening, 5.0 mg/kg for piglets, 6.0 mg/kg for pigs for fattening and 4.4 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 0.2 mg/kg. The use of nutmeg oil in animal feed was expected to be of no concern for consumers and the environment. The additive should be considered as irritant to skin and eyes and as a skin and respiratory sensitiser. Based on the presence of safrole, nutmeg oil is classified as carcinogen (category 1B) and handled accordingly. Since nutmeg oil was recognised to flavour food and its function in feed would be the same, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of juniper oil and juniper tincture obtained from the berries of Juniperus communis L., when used as sensory additives for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that juniper oil is safe up to the maximum proposed use levels in complete feed of 5 mg/kg for laying hens, 15 mg/kg for veal calves (milk replacer) and cattle for fattening and 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 4 mg/kg for chickens for fattening, 5 mg/kg for turkeys for fattening, 7 mg/kg for piglets, 8 mg/kg for pigs for fattening, 10 mg/kg for sows, dairy cows, 16 mg/kg for sheep, goats and horses, 6 mg/kg for rabbits, 17 mg/kg for salmonids, 18 mg/kg for dogs and 3 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 3 mg/kg complete feed. The FEEDAP Panel concluded that juniper tincture is safe up to the maximum proposed use level in feed of 45 mg/kg complete feed or water for drinking for all animal species. No concerns for consumers and the environment were identified following the use of the additives to the highest safe level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. Since the berries of J. communis and their preparations are recognised to flavour food and their function in feed would be the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 oleoresin of Pinus pinaster Aiton (pine white oil, also known as turpentine oil), when used as a sensory additive in feed and water for drinking for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels of 35 mg/kg for laying hens, piglets, pigs for fattening, sows, rabbits, salmonids, 50 mg/kg for veal calves (milk replacer), cattle for fattening, dairy cows, horses, dogs and ornamental fish, 20 mg/kg for cats. For the other species, the calculated safe concentrations in complete feed were 25 mg/kg complete feed for chickens for fattening, 33 mg/kg for turkeys for fattening and 14 mg/kg for ornamental birds. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 20 mg/kg complete feed. No concerns for consumers were identified following the use of pine white oil up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of pine white oil at the proposed use level in feed was not expected to pose a risk for the environment. Pine white oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]