Safety and efficacy of feed additives consisting of rosemary tinctures obtained from the leaves of Salvia rosmarinus Spenn. for use in all animal species (FEFANA asbl)

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.

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.

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 expressed sweet orange oil and its fractions obtained from the fruit peels of Citrus sinensis (L.) Osbeck, when used as sensory additives (flavourings) in feed and water for drinking for all animal species. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by‐products as part of daily feed, the use of the expressed orange oil and its fractions was not expected to increase the exposure to perillaldehyde to a relevant extent (< 10%). For dogs, cats, ornamental fish and ornamental birds not normally exposed to citrus by‐products, no conclusion can be drawn. For the other species, the FEEDAP Panel concluded that the additives under assessment are safe at the maximum proposed use levels in complete feed. 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 consumer safety were identified following the use of the additives up to the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The use of the additives under the proposed conditions of use in animal feed was not expected to pose a risk for the environment. Expressed orange oil and its fractions were recognised to flavour food. Since their 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 patchouli oil from the leaves of Pogostemon cablin Benth. (patchouli 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 safe up to the maximum use level in complete feed of 7.5 mg/kg for chickens for fattening, laying hens, turkeys for fattening, pigs for fattening, horses, salmonids, shrimps, rabbits, dogs, cats and ornamental fish, 24 mg/kg for piglets, 35 mg/kg for sows, 34 mg/kg for dairy cows, 60 mg/kg for veal calves (milk replacer) and 53 mg/kg for cattle for fattening, sheep and goats. These conclusions were extrapolated to other physiologically related minor species. For any other species, the additive is safe at 7.5 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. No concerns for consumers were identified following the use of patchouli oil up to the highest proposed use level in feed. Regarding user safety, the essential oil under assessment should be considered as irritant to skin and eyes, and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions is not expected to pose a risk to the environment. Since the leaves of P. cablin 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 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.

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.

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.

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 of Salvia officinalis L. (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 sage oil is considered safe up to the maximum proposed use levels in complete feed of 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 3 mg/kg for chickens for fattening and turkeys for fattening, 4 mg/kg for laying hens and rabbits, 5 mg/kg for piglets, 6 mg/kg for pigs for fattening, 7 mg/kg for sows and dairy cows, 11 mg/kg for veal calves (milk replacers) and salmonids, 10 mg/kg for cattle for fattening, sheep/goats and horses, 12 mg/kg for dogs and 2 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 2 mg/kg complete feed. The FEEDAP Panel considered that the use of 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 sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, sage oil 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 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, 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 an essential oil from the leaves of Citrus x aurantium L. (petitgrain bigarade oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentrations in complete feed are 10 mg/kg for chicken for fattening, 14 mg/kg for laying hen, 13 mg/kg for turkey for fattening, 17 mg/kg for piglet, 20 mg/kg for pig for fattening, 25 mg/kg for lactating sow, 43 mg/kg for veal calf (milk replacer), 38 mg/kg for cattle for fattening, sheep, goat and horse, 24 mg/kg for dairy cow, 15 mg/kg for rabbit, 42 mg/kg for salmon, 44 mg/kg for dog and 8 mg/kg for cat. 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. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Petitgrain bigarade 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.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of 17 compounds belonging to chemical group 31 (aliphatic and aromatic hydrocarbons). They are currently authorised for use as flavours in food. This opinion concerns eight compounds from this group. The FEEDAP Panel concluded that b-pinene, a-pinene, b-caryophyllene, myrcene, camphene, b-ocimene and δ-3-carene are safe at the proposed maximum dose level (5 mg/kg complete feed) for all animal species, except myrcene and β-ocimene when 4 mg/kg would apply for cats. For valencene, the calculated safe use level is 1.5 mg/kg complete feed for cattle, salmonids and non-food producing animals, and 1.0 mg/kg complete feed for pigs and poultry. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feeds. The Panel is unable to conclude on user safety in the absence of specific data. The use of the compounds in animal nutrition would not pose a risk for the environment provided that the concentrations regarded as safe for the target species are not exceeded. As all of 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. However, in the absence of data on the stability/survival in water for drinking, the FEEDAP Panel is unable to conclude on the safety or efficacy of the substances under this mode of delivery.

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 6‐phytase (VTR‐phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR‐phytase consists of 6‐phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.370). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR phytase (liquid/solid) produced by Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid VTR phytase and powder VTR phytase are non‐irritant to skin or eyes but should be considered skin and respiratory sensitisers. The additive has the potential to be efficacious in laying hens at 1,000 U phytase/kg complete feed. The conclusion can be extrapolated to other birds for egg production or breeding. The FEEDAP Panel cannot conclude on the efficacy of all pigs or growing poultry species.

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.

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 an essential oil from the fruits of Litsea cubeba (Lour.) Pers. (litsea berry oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that litsea berry oil is safe up to the maximum proposed use level of 125 mg/kg complete feed for ornamental fish. For the other species, the calculated safe concentration in complete feed are 11 mg/kg for chicken for fattening, 16 mg/kg for laying hen, 14 mg/kg for turkey for fattening, 19 mg/kg for piglet, 23 mg/kg for pig for fattening, 28 mg/kg for lactating sow, 48 mg/kg for veal calf (milk replacer), 43 mg/kg for cattle for fattening, sheep, goat and horse, 28 mg/kg for dairy cow, 17 mg/kg for rabbit, 47 mg/kg for salmon, 50 mg/kg for dog and 8.5 mg/kg for cat. The FEEDAP Panel also concluded that the use of litsea berry oil at the maximum proposed use level in water for drinking of 1 mg/kg is safe for all animal species. Simultaneous use in feed and water for drinking may lead to the maximum safe dose being exceeded. No concerns for consumer safety were identified following the use of the additive up to the highest safe use level in feed for the target animals. The essential oil under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Litsea berry oil is 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.

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 dried extracts prepared from the dried roots of Echinacea angustifoliaDC. or the dried aerial parts of Echinacea purpurea (L.) Moench, when used as sensory feed additives for cats and dogs. E. angustifolia extract is specified to contain at least 4% echinacosides and E. purpurea extract at least 4% total phenols. Since about 75% of the composition of the extracts remained uncharacterised, the FEEDAP Panel was unable to conclude on the safety for the target species. In the absence of data, no conclusions can be drawn on the potential of the extracts to be dermal/eye irritants or skin sensitisers. In the absence of evidence that the extracts act as flavours in animal feed or have an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additives.

Following a request from the European Commission, the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of feed additives prepared from Piper nigrum L.: black pepper oil and black pepper oleoresin for all animal species and a supercritical extract of black pepper for use in dogs and cats. The Panelconcludes that black pepper oil is safe in complete feed up to 5mg/kg for chickens for fattening and other growing poultry, 8mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction, 7mg/kg for turkeys for fattening, 9.5mg/kg for piglets and other growing Suidae, 11.5mg/kg for pigs for fattening, 14mg/kg for sows and dairy cows (and other dairy ruminants), 8.5mg/kg in rabbits and 20mg/kg in veal calves, cattle for fattening (and other growing ruminants), sheep, goats, horses, salmonids (and other fin fish), dogs, cats and ornamental fish. For all the other species, the additive is considered safe at 5mg/kg complete feed. The supercritical extract of black pepper is safe up to the maximum proposed use levels in complete feed of 1.5mg/kg for cats and dogs. The black pepper oleoresin is safe in complete feed up to 12.5mg/kg for veal calves, 11.5 for cattle for fattening and other growing ruminants, sheep/goats and horses, 14mg/kg for dogs 13.5 for mg/kg for salmonids and other fin fish and 51.5 for ornamental fish. For the other species, the calculated safe concentrations in complete feed are 1mg/kg for chickens for fattening and other growing poultry, 1.4mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction, 1.3 for turkeys for fattening, 1.7mg/kg for piglets and other growing Suidae, 2mg/kg for pigs for fattening, 2.5mg/kg for sows, 2.4mg/kg for dairy cows and other dairy ruminants, 1.5mg/kg for rabbits, 3.8mg/kg for cats. For all the other species, the additive is considered safe at 1mg/kg complete feed. No concerns for consumers and environment were identified following the use of the additives at the use levels considered safe for the target animals. The additives are irritant to skin and eyes, and act as dermal and respiratory sensitisers. The additives are recognised to flavour food and since their function in feed would be essentially the same, no further demonstration of efficacy is necessary.