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"Brantom, Paul"
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Assessment of a feed additive containing Enterococcus lactis NCIMB 11181 (Lactiferm®) for weaned piglets, calves for fattening and calves for rearing for the renewal of its authorisation (Chr. Hansen A/S)
by
Pechová, Alena
,
Tarrés‐Call, Jordi
,
Mayo, Baltasar
in
Additives
,
Antimicrobial agents
,
calves
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive for weaned piglets, calves for fattening and calves for rearing. The product under assessment is based on a strain originally identified as Enterococcus faecium. During the current assessment, the active agent has been reclassified as Enterococcus lactis. The additive currently authorised is marketed in two formulations: Lactiferm Basic 50 (a solid formulation to be used in feed), and Lactiferm WS200 (a solid ‘water‐soluble’ formulation to be used in water for drinking). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that the use of Lactiferm® under the authorised conditions of use remains safe for the target species (calves up to 6 months and weaned piglets up to 35 kg), consumers and the environment. The Lactiferm WS200 formulation of the additive is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It is not possible to conclude on the irritating potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both forms of the additive to cause skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Safety and efficacy of sodium saccharin when used as a feed flavour for piglets, pigs for fattening, calves for rearing and calves for fattening
2018
Sodium saccharin is intended to be used as a sweetener in feed and water for drinking for piglets, pigs for fattening and veal calves. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the proposed maximum use level of 150 mg sodium saccharin/kg feed as safe for calves and pigs for fattening. For piglets (sucking and weaned piglets), a lower level of 100 mg sodium saccharin/kg complete feed is considered safe. The corresponding maximum safe concentrations in water for drinking are 30 mg/L for piglets and 50 mg/L for pigs for fattening, respectively. The maximum safe concentrations of sodium saccharin in feed and water for drinking are derived under the premise that only one source, feed or water for drinking, contains the additive. The FEEDAP Panel concludes that no concern for the consumer would result from the use of sodium saccharin in feed and water for drinking at the dose considered safe for the target species. The precautions for handling the product proposed by the applicant are considered to be sufficient to ensure user safety. The FEEDAP Panel concludes that the use of sodium saccharin at the dose considered safe for target species is unlikely to have detrimental effects on the terrestrial and freshwater compartments. The high mobility and relative persistence of saccharin and the high persistency of its degradation product 4‐hydroxysaccharin indicate that groundwater contamination above 0.1 μg/L is likely to occur. Since the function of sodium saccharin in feed for the target species is essentially the same as that in food, the FEEDAP Panel concludes that no demonstration of efficacy is necessary.
Journal Article
Safety and efficacy of feed additives consisting of expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle for use in all animal species (FEFANA asbl)
by
Pechová, Alena
,
Westendorf, Johannes
,
Chesson, Andrew
in
Additives
,
Animal feed
,
Animal species
2021
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 lemon oil and distilled lemon oil from Citrus limon (L.) Osbeck and lime oil from Citrus aurantiifolia (Christm.) Swingle, when used as sensory additives in feed for all animal species. The use of the expressed lemon oil and its residual fraction and the use of lime oil in feed is not expected to increase the exposure to furocoumarins and methoxycoumarins and perillaldehyde of those target species that are already fed citrus by‐products a relevant extent (< 10%). For companion animals and ornamental fish not normally exposed to citrus by‐products, no conclusion can be drawn. For the other species and for the distilled fraction of expressed lemon oil, the FEEDAP Panel concludes that the additives under assessment are safe at the maximum proposed or at reduced use levels in complete feed. The Panel considers 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 at the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes and the respiratory tract and as skin sensitisers. Since expressed lemon oil and its fractions contain furocoumarins, they may cause phototoxicity. The use of the additives under the proposed conditions of use in animal feed is not expected to pose a risk for the environment. Since C. limon and C. aurantiifolia and their preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.
Journal Article
Safety and efficacy of a feed additive consisting of an essential oil from the leaves of Laurus nobilis L. (laurel leaf oil) for all animal species (FEFANA asbl)
by
Pechová, Alena
,
Westendorf, Johannes
,
Schrenk, Dieter
in
Additives
,
Animal feed
,
Animal species
2023
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 Laurus nobilis L. (laurel leaf oil), when used as a sensory additive for all animal species. The additive contains up to 4% methyleugenol. The use of the additive at 2 mg/kg complete feed in dogs and cats was considered of low concern. For other long‐living and reproductive animals, the use of the additive at 10 mg/kg was considered of concern. For short‐living animals, the Panel had no safety concern when the additive is used at 10 mg/kg complete feed for turkeys for fattening, piglets and other growing Suidae, pigs for fattening, veal calves (milk replacer), cattle for fattening and other growing ruminants, horses and rabbits for meat production, salmonids and other fin fish; and at 8.5 mg/kg for chickens for fattening, other growing poultry and other minor species for fattening. The use of laurel leaf oil up to the highest level in feed which was considered of no concern for target animals was also expected to be of no concern for consumers. The additive should be considered as irritant to skin and eyes and the respiratory tract. Due to the high concentration of methyleugenol (≥ 1%), the additive was classified by the applicant as suspected of causing genetic defects and of causing cancer and should be handled accordingly. The use of the additive under the proposed conditions of use was not expected to pose a risk for the environment. Since the leaves of L. nobilis and their preparations were recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was considered necessary.
Journal Article
Safety and efficacy of a feed additive consisting of an extract of olibanum from Boswellia serrata Roxb. ex Colebr. for use in dogs and horses (FEFANA asbl)
2022
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 olibanum extract from Boswellia serrata Roxb. ex Colebr., when used as a sensory additive (flavouring) in feed for all dogs and horses. The FEEDAP Panel concluded that the additive under assessment is safe for horses at the maximum proposed use level of 100 mg/kg in complete feed. For dogs, the calculated safe concentration in feed is 330 mg/kg complete feed. The additive is considered safe for consumers when used at the proposed conditions of use in horses. The additive under assessment should be considered as non‐irritant to skin and eyes, but in the absence of data, no conclusion can be drawn on its potential to be a dermal and respiratory sensitiser. The use of the additive under the proposed conditions of use in feed for horses was not expected to pose a risk for the environment. Boswellia species and their preparations 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.
Journal Article
Risks associated with endotoxins in feed additives produced by fermentation
by
Brantom, Paul G.
,
Dierick, Noël
,
Bampidis, Vasileios
in
Agricultural Workers' Diseases - chemically induced
,
Air Pollutants, Occupational - poisoning
,
Animal Feed - poisoning
2016
Increasingly, feed additives for livestock, such as amino acids and vitamins, are being produced by Gram-negative bacteria, particularly
Escherichia coli
. The potential therefore exists for animals, consumers and workers to be exposed to possibly harmful amounts of endotoxin from these products. The aim of this review was to assess the extent of the risk from endotoxins in feed additives and to calculate how such risk can be assessed from the properties of the additive. Livestock are frequently exposed to a relatively high content of endotoxin in the diet: no additional hazard to livestock would be anticipated if the endotoxin concentration of the feed additive falls in the same range as feedstuffs. Consumer exposure will be unaffected by the consumption of food derived from animals receiving endotoxin-containing feed, because the small concentrations of endotoxin absorbed do not accumulate in edible tissues. In contrast, workers processing a dusty additive may be exposed to hazardous amounts of endotoxin even if the endotoxin concentration of the product is low. A calculation method is proposed to compare the potential risk to the worker, based on the dusting potential, the endotoxin concentration and technical guidance of the European Food Safety Authority, with national exposure limits.
Journal Article
Safety and efficacy of feed additives consisting of essential oils derived from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove bud oil and clove leaf oils) for all animal species (FEFANA asbl)
by
Pechová, Alena
,
Westendorf, Johannes
,
Chesson, Andrew
in
Additives
,
Animal feed
,
Animal species
2023
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.
Journal Article
Safety of 41 flavouring compounds providing a herbal flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl)
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read‐across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.
Journal Article
Safety and efficacy of the feed additive consisting of a preparation of carvacrol, cinnamaldehyde and capsicum oleoresin (XTRACT EVOLUTION‐B, CODE X60‐6930, 4d11) for chickens for fattening for the renewal of its authorisation (Pancosma France S.A.S)
2025
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of carvacrol, cinnamaldehyde and capsicum oleoresin (XTRACT EVOLUTION‐B, CODE X60‐6930) (4d11) as a zootechnical feed additive for chickens for fattening for the renewal of its authorisation. The applicant provided evidence that the additive currently in the market complies with the conditions of the existing authorisation and that the production process has not been modified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for the target species, consumers and the environment. Regarding user safety, the additive should be considered a skin, eye and respiratory tract irritant and a skin sensitiser. Exposure of users by any route is considered a risk. The present application for renewal of the authorisation does not include any proposed modification that would have an impact on the efficacy of the additive, and therefore, there is no need to re‐assess the efficacy of the additive.
Journal Article
Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering aerial parts of Mentha arvensis L. (cornmint oil) for use in all animal species (FEFANA asbl)
by
Pechová, Alena
,
Westendorf, Johannes
,
Chesson, Andrew
in
Additives
,
Animal feed
,
Animal species
2026
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 aerial parts of Mentha arvensis L. (cornmint 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 8.8 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of the additive 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. Exposure of users by any route is considered a risk. Since the flowering aerial parts of M. arvensis L. 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.
Journal Article