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"Zootechnical additives"
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Safety and efficacy of Kelforce® (l‐glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na4)) as a feed additive for chickens for fattening
2018
l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na4) (Kelforce®) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na4, respectively. Kelforce® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na4/kg complete feed. Based on the toxicological profile of GLDA‐Na4 and the consumer exposure to GLDA‐Na4 and to nitrilotriacetic acid trisodium salt (NTA‐Na3; an impurity of the additive), the use of Kelforce® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na4 is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.
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
Assessment of the feed additive consisting of Enterococcus lactis NCIMB 10415 (Cylactin®) for cats and dogs for the renewal of its authorisation (DSM Nutritional Products Ltd.)
2024
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 Cylactin® as a zootechnical feed additive for cats and dogs. The active agent of the additive is Enterococcus lactis NCIMB 10415 and the micro‐encapsulated formulation, Cylactin® LBC ME5 PET, was assessed. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for cats and dogs. Regarding user safety, the additive was not shown to be skin and eye irritant, but it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Efficacy of a feed additive consisting of carvacrol (Nimicoat®) for weaned piglets (Techna France Nutrition)
2024
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 efficacy of a feed additive consisting of carvacrol (Nimicoat®) as a zootechnical feed additive for weaned piglets at the recommended use level of 250 mg/kg complete feed. In a previous assessment, three efficacy trials and one tolerance–efficacy trial were assessed. Only one of the efficacy trials was considered to support the efficacy at the recommended use level. The applicant provided amendments to two previously submitted studies and a new trial. The amendments to the previously submitted studies did not change the conclusions from the previous assessment. The new efficacy study showed a significant improvement of the zootechnical parameters. Two studies showed positive and significant effects on the performance of the weaned piglets when the additive was administered at 250 mg/kg feed. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.
Journal Article
Safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ chromium) for all growing poultry species (KEMIN EUROPA N.V)
2025
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate as zootechnical feed additive for all growing poultry species. The safety and efficacy of chromium propionate has been assessed previously in 2021 by the Panel and it was concluded that the additive is considered safe for chickens for fattening and chickens reared for laying/breeding at the proposed use level 0.2–0.4 mg Cr/kg complete feed, but the conclusion was not extrapolated to other growing species. During that assessment, the EU Reference Laboratory for feed additives (EURL) was not in a position to recommend the method for official control for the quantification of the organic chromium content in premixtures and feedingstuffs. The applicant subsequently proposed a new method of analyses, incorporating a tracer in the composition of a premixture, which has been evaluated by EURL and recommended as official method for the quantification of the organic chromium content in premixtures and feedingstuffs. The safety of the use of the microtracer has been assessed in 2024. The Panel considered that the use of the microtracer as proposed in the conditions of use would not introduce safety concerns for the target animals, the consumers and terrestrial environmental compartment, but no conclusion could be made for the groundwater. The microtracer should be considered a dermal and respiratory sensitiser. In the current assessment, the FEEDAP Panel concluded that the additive is safe for turkeys for fattening at the maximum proposed supplementation level of 0.4 mg Cr/kg feed, but a margin of safety cannot be established. This conclusion can be extended to turkeys reared for reproduction, but cannot be extrapolated to other growing poultry species. The use of the additive according to the proposed conditions of use causes no concern for consumer safety. The conclusions made previously for user safety remain the same: the additive does not present a risk by inhalation, the additive is irritant to the eyes, not irritant to the skin and is not a skin sensitiser. The use of the additive is considered safe for the environment. The previous conclusion on efficacy remains valid.
Journal Article
Safety and efficacy of a feed additive consisting of benzoic acid (Kalama® Animal Feed Grade Benzoic acid) for weaned piglets and pigs for fattening (Emerald Kalama Chemical, B.V)
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use.
Journal Article
Safety and efficacy of a feed additive consisting of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.)
by
Pechová, Alena
,
Mayo, Baltasar
,
Durjava, Mojca
in
Additives
,
all avian species
,
Animal welfare
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union. Bafasal® is intended to be used in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 106 PFU/bird, to reduce the Salmonella spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In a previous opinion, the FEEDAP Panel could not conclude on the additive's potential to be irritant or a dermal sensitiser, or on its efficacy for any avian species due to insufficient data. The applicant provided supplementary information to address these data gaps. The new data showed that Bafasal® is not a skin or eye irritant. No conclusions could be drawn on its skin sensitisation potential. The Panel was not in the position to conclude on the efficacy of Bafasal® to improve the zootechnical performance of the target species based on the available data. The additive showed the potential to decrease the counts of two strains of Salmonella Enteritidis in boots swabs and caecal digesta of chickens for fattening. No conclusions could be drawn on the capacity of Bafasal® to reduce the contamination of other Salmonella enterica strains, serovars or other species of Salmonella. The potential of Bafasal® to reduce the Salmonella spp. contamination poultry carcasses and/or the environment is limited. The FEEDAP Panel recommended a post‐market monitoring plan to address the potential selection and spread of resistant variants of Salmonella to Bafasal®.
Journal Article
Efficacy of Availa®Cr (chromium chelate of dl‐methionine) as a feed additive for dairy cows (Zinpro Animal Nutrition (Europe), Inc)
by
Pechová, Alena
,
Innocenti, Matteo Lorenzo
,
Ortuño, Jordi
in
Additives
,
Animal lactation
,
Animal nutrition
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Availa®Cr (active compound: chromium chelate of dl‐methionine) as a feed additive for dairy cows. In a previous opinion, the FEEDAP Panel concluded that Availa®Cr at a maximum recommended use level of 0.5 mg Cr(III) (8 mg Cr from Availa®Cr/cow per day) was safe for dairy cows and the consumers. Additionally, the FEEDAP Panel considered that the additives posed a risk to the user by inhalation, it was not irritant to skin and eyes, and it should be considered a skin sensitiser. The Panel could not conclude on the efficacy of the additive at the proposed conditions of use. Since the new information provided in the current application is lacking sufficient evidence, the FEEDAP Panel is still not in the position to conclude on the efficacy of chromium dl‐methionine from Availa®Cr.
Journal Article
Safety and efficacy of a feed additive consisting of lanthanum carbonate octahydrate for dogs (Porus GmbH)
2024
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lanthanum carbonate octahydrate as a zootechnical feed additive for dogs. The additive is already authorised for use in feed for cats. The FEEDAP Panel concluded that the additive lanthanum carbonate octahydrate is safe for adult dogs at the maximum recommended level of 7500 mg/kg complete feed. The additive is not irritant to skin or eyes, is not a skin sensitiser and exposure by inhalation is considered to be unlikely. The Panel also concluded that lanthanum carbonate octahydrate is efficacious in the reduction of phosphorus bioavailability in adult dogs at the minimum inclusion level of 1500 mg/kg complete feed.
Journal Article
Safety and efficacy of a feed additive consisting of an aqueous extract of Citrus limon (L.) Osbeck (Citrozest®) for weaned piglets and all growing poultry species (Nor‐Feed SAS)
2022
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an aqueous extract of Citrus limon (L.) Osbeck (Citrozest®) when used as a zootechnical additive in feed for weaned piglets and all growing poultry species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe for the target species up to the maximum proposed use level of 1,000 mg/kg complete feed. No concerns for consumers were identified following the use of additive up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of Citrozest® as a feed additive is considered safe for the environment. In the absence of adequate data, the FEEDAP Panel could not conclude on the efficacy of Citrozest® as a zootechnical additive for weaned piglets and all growing poultry species under the proposed conditions of use.
Journal Article