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 and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B-Act®) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis 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 or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B-Act® is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B-Act® is considered a respiratory sensitiser. B-Act® when supplemented at 1.6 × 109 CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B-Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens.
Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Durjava M.F., et al. (2021). Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B-Act®) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.). EFSA JOURNAL, 19(3), 1-11 [10.2903/j.efsa.2021.6449].
Safety and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (B-Act®) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.)
Martelli G.;Revez J.;
2021
Abstract
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 and efficacy of the feed additive consisting of Bacillus licheniformis DSM 28710 (trade name: B-Act®) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. B. licheniformis 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 or has toxigenic potential. Following the QPS approach, B. licheniformis DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B-Act® is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B-Act® is considered a respiratory sensitiser. B-Act® when supplemented at 1.6 × 109 CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B-Act® with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens.File | Dimensione | Formato | |
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