46 research outputs found
Assessment of the efficacy of a feed additive consisting of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 for dogs (NBF LANES)
No full textFollowing a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 as a zootechnical additive for dogs. The additive is a preparation of viable cells of L. reuteri DSM 32203 and it has not been previously authorised as a feed additive in the European Union. The additive is intended for use in complete feed for dogs at a minimum use level of 6 × 10(9) colony forming units (CFU) per animal and day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM 32203 for dogs. The applicant has provided supplementary information to support the efficacy of the additive to dogs. Based on the data provided, the FEEDAP Panel concludes that L. reuteri DSM 32203 has the potential to improve faecal consistency by reducing the moisture content of stools from dogs receiving the additive at 1 × 10(10) CFU/kg feed. However, the Panel has some reservations on the effects in the moisture content of stools, which if maintained over time might cast doubts on the benefits on the long‐term use of the additive since it could lead to constipation
Efficacy of a feed additive consisting of nicarbazin (Coxar®) for use in turkeys for fattening (Huvepharma N.V.)
No full textFollowing a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of the coccidiostat nicarbazin (Coxar(R)) when used in feed for turkeys for fattening. On the basis of the new data provided, the FEEDAP Panel updated its previous conclusions on the efficacy of Coxar(R) as follows: the two new floor pen studies showed efficacy of nicarbazin from Coxar(R) reducing the adverse clinical consequences of an Eimeria infection in turkeys. Overall, when considering also the positive floor pen study previously reported and the three positive anticoccidial sensitivity tests, the FEEDAP Panel concludes that Coxar(R) has the potential to be efficacious against coccidiosis of turkeys for fattening at 100 mg nicarbazin/kg complete feed. (c) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority
Safety and efficacy of a feed additive consisting of Bacillus velezensis NITE BP-01844 (BA-KING®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species (Toa Biopharma Co., Ltd.)
No full textFollowing 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 and efficacy of BA-KING(R) Bacillus velezensis when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NITE BP-01844 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, BA-KING(R) is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. BA-KING(R) is not irritant to skin but is potentially irritant to eyes. In addition, should be considered a skin and respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of BA-KING(R) for the target species. (c) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority
Safety and efficacy of a feed additive consisting of ferric citrate chelate (CI-FERTM) for poultry species for fattening or reared up to the point of lay (Akeso Biomedical, Inc.)
No full textFollowing 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 and efficacy of ferric citrate chelate (CI-FER (TM)) as a zootechnical additive for poultry species for fattening or reared up to the point of lay. The product had been already assessed by the FEEDAP Panel for use in suckling and weaned piglets and minor porcine species. The application was for an extension of use to poultry species for fattening or reared up to the point of lay. The FEEDAP Panel considers that the new use would not raise safety concerns for the consumers and the environment and retained the previous conclusions as regards to the user: CI-FER (TM) does not pose a risk by inhalation, it is non-irritant to the skin but should be considered as an eye irritant and as a skin sensitiser. Owing to the limitations identified in the tolerance trial submitted, the FEEDAP Panel could not conclude on the safety of the additive for the target species. Regarding the efficacy, three studies were submitted but two of them were not considered further in the assessment due to the husbandry conditions to which the animals were subject to. Therefore, the FEEDAP Panel could not conclude on the efficacy of the additive
Safety and efficacy of a feed additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species (Lactosan GmbH & Co.KG.)
No full textFollowing 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 and efficacy of an additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 x 10(8) colony-forming units (CFU)/kg fresh material. The bacterial species P. freudenreichii and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to assessment. As the identity of the strains has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strains as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant for eyes or skin but should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin sensitiser. The additive at the proposed application rate of 1 x 10(8) CFU/kg fresh plant material showed the potential to improve the aerobic stability silage with dry matter content ranging from 30% to 70%
Safety and efficacy of a feed additive consisting of Bacillus velezensis DSM 15544 (Calsporin®) for dairy cows and other dairy ruminants (Asahi Biocycle Co. Ltd.)
No full textFollowing 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 assessment of Calsporin(R) (Bacillus velezensis DSM 15544) as a zootechnical additive for dairy cows and other dairy ruminants. The product under assessment is based on viable spores of Bacillus velezensis DSM 15544. B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and compliance with the applicable qualifications confirmed. Therefore, B. velezensis DSM 15544 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Calsporin(R) is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. The FEEDAP Panel is not in the position to conclude on the efficacy of Calsporin(R) for dairy cows or other dairy ruminants based on the data provided. (C) 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority
Assessment of the feed additive consisting of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG)
No full textFollowing 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 assessment of the application for renewal of authorisation of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for use in forage for all animal species. The additive aims at improving the production of silage and is authorised for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety L. buchneri DSM 12856 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation
Assessment of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 21762 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG)
No full textFollowing 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 assessment of the application for renewal of authorisation of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 21762, as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority
Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)
No full textAmaferm(R) is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm(R) complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm(R) remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser
Assessment of the feed additive consisting of copper chelate of hydroxy analogue of methionine for all animal species for the renewal of its authorisation (Novus Europe S.A./N.V.)
No full textThe Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of copper chelate of hydroxy analogue of methionine (Mintrex (R) Cu) for all animal species. The FEEDAP Panel has delivered two opinions (in 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Copper chelate of hydroxy analogue of methionine' containing 18% copper, 79.5-81% (2-hydroxy-4-methylthio)butanoic acid (DL-methionine hydroxy analogue, HMTBa) and 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: >= 16% copper and >= 78% HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Mintrex((R))Cu is considered as a skin and eye irritant and a skin sensitiser; the risk of respiratory sensitisation is considered low. The present application did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority
