Safety and efficacy of a feed additive consisting of Bacillus paralicheniformisDSM 5749 and Bacillus subtilisDSM 5750 (BioPlus® 2B) for piglets, calves for fattening and other growing ruminants (Chr. Hansen A/S).

Maria De Lourdes Bastos,Miguel Prieto,Henrik Christensen,Gloria López‐Gálvez,Baltasar Mayo,Roberto Edoardo Villa,Joana Revez,Montserrat Anguita,Elisa Pettenati,Alena Pechová,Rosella Brozzi,Maria Vittoria Vettori,Fernando Ramos,Secundino López Puente,Mariana Petkova,Birgit Dusemund,Vasileios Bampidis,Giovanna Azimonti,Francesca Marcon,Marta López‐Alonso,Yolanda Sanz,Ruud Woutersen,Maryline Kouba,Yolanda García‐Cazorla,Matteo Lorenzo Innocenti ,Mojca Fašmon Durjava

doi:10.2903/j.efsa.2023.7859

Maria De Lourdes Bastos, Miguel Prieto + Show 24 more

Open Access

https://doi.org/10.2903/j.efsa.2023.7859

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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 a feed additive consisting of two bacilli strains (tradename: BioPlus® 2B) when used in suckling piglets, calves for fattening and other growing ruminants. BioPlus® 2B is composed of viable cells of Bacillus subtilis DSM 5750 and Bacillus licheniformis DSM 5749. In the course of the current assessment, the latest strain was reclassified as Bacillus paralicheniformis. BioPlus® 2B is intended for use in feedingstuffs and water for drinking for the target species at the minimum inclusion level of 1.3× 109CFU/kg feed and 6.4× 108CFU/l water, respectively. B. paralicheniformis and B. subtilis are considered eligible for the qualified presumption of safety (QPS) approach. The identity of the active agents was established, and the qualifications regarding the lack of acquired antimicrobial resistance genes, toxigenic potential and bacitracin production ability were complied with. Following the QPS approach, B. paralicheniformis DSM 5749 and B. subtilis DSM 5750 are presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, BioPlus® 2B was also considered safe for the target species, consumers and the environment. BioPlus® 2B is not irritant to the eyes or skin but should be considered a respiratory sensitiser. The Panel could not conclude on the skin sensitisation potential of the additive. BioPlus® 2B when supplemented at 1.3× 109CFU/kg complete feed and 6.4× 108CFU/l water for drinking has the potential to be efficacious in suckling piglets, calves for fattening and other growing ruminants (e.g. sheep, goat, buffalo) at the same developmental stage.

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