Effects of microbial lipases on hydrolyzed milk fat at different time intervals in flavour development and oxidative stability.

The interest in application of biocatalysis during natural milk fat flavours development has increased rapidly and lipases have become the most studied group in the development of bovine milk fat flavours. Lipozyme-435, Novozyme-435 and Thermomyces lanuginosus Immobilized (TL-IM) lipases were used to hydrolyze anhydrous milk fat (AMF) and anhydrous buffalo milk fat (ABF) and their volatile flavouring compounds were identified by solid-phase micro-extraction gas chromatography/mass spectrometry (SPME-GC/MS) and then compared at three hydrolysis intervals. Both AMF and ABF after lipolysis produced high amount of butanoic and hexanoic acids and other flavouring compounds; however, highest amount were produced by Lipozyme-435 and Novozyme-435 followed by TL-IM. The hydrolyzed products were assessed by Rancimat-743 for oxidative stability and found both that, for AMF and ABF treated butter oil, Lipozyme-435 and TL-IM were generally more stable compared to Novozyme-435. For both AMF and ABF treated butter oil, Lipozyme-435 was observed to cause no further oxidation consequences which indicates Lipozyme-435 was stable during hydrolysis at 55 °C for 24 h.

Modification of the terms of authorisation regarding the maximum inclusion level of a feed additive consisting of nonanoic acid for all pigs and poultry species (Anitox Corporation).

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.

Safety and efficacy of feed additives consisting of ginkgo tinctures obtained from the leaves of Ginkgo biloba L. 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.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) 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 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.

Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) for 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 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.

Safety and efficacy of a feed additive consisting of a dry extract obtained from the leaves of Ginkgo biloba L. (ginkgo extract) for horses, dogs, cats, rabbits and guinea pigs (FEFANA asbl).

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.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of Carum carvi L. (caraway oil) for 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 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.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of Apium graveolens L. (celery seed oil) for 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 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.

Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) for 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 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.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil) 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 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.

Safety and efficacy of a feed additive consisting of a tincture derived from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture) for poultry, horses, dogs and cats (FEFANA asbl).

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.

Safety and efficacy of a feed additive consisting of an essential oil derived from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. (cajuput oil) for use in all animal species (FEFANA asbl).

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.

Safety and efficacy of a feed additive consisting of a tincture derived from the roots of Panax ginseng C.A.Mey. (ginseng tincture) for horses, dogs and cats (FEFANA asbl).

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.

Safety of a feed additive consisting of sodium saccharin for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sodium saccharin as a sensory feed additive (flavouring compound) for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening. In a previous assessment, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) could not conclude on the safety of the additive for the environment because concentrations of the additive or its degradation product 4-hydroxysaccharin in groundwater above 0.1 µg/L were likely to occur. In addition, regarding user safety, sodium saccharin was considered to be potentially harmful by inhalation or by contact to skin and eyes. In the current opinion, the applicant restricted the use to suckling and weaned piglets and up to a use level of 5 mg/kg complete feed. In relation to the user safety, the additive was neither a skin or eye irritant, nor a dermal sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be toxic by inhalation. Regarding the safety of the additive for the environment, the new conditions of use describe a maximum use level of 5 mg sodium saccharin/kg feed. The applicant indicated that a restriction to a lower use level due to environmental safety would be accepted and submitted an environment risk assessment based on a use level of 1.13 mg sodium saccharin/kg feed. This use level cannot be considered safe. The estimated use level that would result in a concentration in groundwater below 0.1 µg/L is of 0.022 mg sodium saccharin/kg feed. The available data do not allow to conclude on the potential effect of the degradation product 4-hydroxysaccharin in ground water.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Anethum graveolens L. (dill tincture) 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 a tincture from the fruit of Anethum graveolens L. (dill 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 approximately 0.9%. The product contained 0.0247% polyphenols (of which 0.0137% were flavonoids) and 0.003% carvone. Estragole was present at concentrations between the limit of detection and the limit of quantification in the five batches examined. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the dill tincture is safe at the maximum proposed use levels of 200 mg/kg complete feed for horses and 50 mg/kg complete feed for all other 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 which is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of dill tincture up to the maximum proposed use levels in feed. Dill tincture 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 estragole cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of dill tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of A. graveolens and its preparations were 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.

Safety of a feed additive consisting of a tincture derived from the roots of Gentiana lutea L. (gentian tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from Gentiana lutea L. (gentian tincture). It is intended to be used as a sensory additive for all animal species. The product is a water/ethanol solution, with a dry matter content of approximately 4.3% and it contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The additive is intended for use in complete feed or drinking water up to a maximum level of 50 mg tincture/kg for all animal species, except horses, for which the proposed use is 200 mg/kg in complete feed. In a previous assessment, due to the genotoxic potential identified in vitro for xanthones (gentisin and isogentisin) and gentiopicroside the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive for long-living animals and on risks of genotoxicity and carcinogenicity for dermal exposure of unprotected users. The additive did not raise safety concern for short-living animals, consumers and the environment. The applicant has provided information in the form of literature to address the previously identified genotoxic activity of xanthones and gentiopicroside and the risk for the user. Considering that the literature identified provided no new evidence, the FEEDAP Panel reiterated that it is not in a position to conclude on the safety of the additive for long-living and reproductive animals. No conclusions could be drawn on the potential of the additive to be a dermal/eye irritant or a skin sensitiser. When handling the tincture, exposure of unprotected users to xanthones (gentisin and isogentisin) and gentiopicroside cannot be excluded. Therefore, to reduce the risk, the exposure of the users should be minimised.

Safety of the feed additive consisting of disodium 5'-inosinate (IMP) produced by Corynebacterium stationisKCCM 80235 for all animal species (CJ Europe GmbH).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of disodium 5'-inosinate (also known as inosine monophosphate, IMP) produced by Corynebacterium stationis KCCM 80235 as a sensory additive, functional group flavouring compounds, for all animal species. In 2022, the FEEDAP Panel issued an opinion on the safety and efficacy of the product. In that assessment, the Panel could not conclude on the safety of the additive for the target species, consumers, users and the environment due to uncertainties on the genetic basis of the streptomycin resistance of the production strain C. stationis KCCM 80235 and on the possible presence of its recombinant DNA in the final product. The applicant provided supplementary data which elucidated the genetic basis of the streptomycin resistance of the production strain and excluded the presence of its DNA in the final product. Therefore, the FEEDAP Panel concluded that IMP produced by C. stationis KCCM 80235 is safe for the target species, consumers, users and the environment. The FEEDAP Panel reiterated its previous concerns on the safety for the target species when using IMP in water for drinking due to hygienic reasons.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Pimpinella anisum L. (anise tincture) 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 a tincture from the fruit of Pimpinella anisum L. (anise 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 approximately 1.6%. The product contained on average 0.0414% polyphenols (of which 0.0144% were flavonoids), 0.0009% anisaldehyde, 0.0003% anethole. Estragole (≤ 1.2 mg/kg) was detected in the additive. The estimated maximum content of furocoumarins was 8.2 mg/kg. The use of the anise tincture in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by-products to a relevant extent (< 10%). For dogs, cats and ornamental fish not normally exposed to citrus by-products, no conclusion could be drawn. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the anise tincture was safe at the maximum proposed use levels in complete feed of 200 mg/kg for horses and 50 mg/kg for poultry, pigs, ruminants, rabbits and salmonids and other fin fish. Anise tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since anise tincture may contain furocoumarins, they may cause phototoxicity. When handling the additive, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of the anise tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of P. anisum and its preparations were recognised to flavour food and their function in feed would be the same, no demonstration of efficacy was necessary.

Safety and efficacy of a feed additive consisting of an essential oil from the seeds of Myristica fragrans Houtt. (nutmeg oil) for 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 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.

Safety and efficacy of a feed additive consisting of a tincture derived from the buds of Pinus sylvestris L. (pine tincture) for use in all animal species (FEFANA abl).

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.