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

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 pi...

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Published in:EFSA journal 2023-03, Vol.21 (3), p.e07859-n/a
Main Authors: Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca, Kouba, Maryline, López‐Alonso, Marta, Puente, Secundino López, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Sanz, Yolanda, Villa, Roberto Edoardo, Woutersen, Ruud, Prieto, Miguel, Anguita, Montserrat, García‐Cazorla, Yolanda, Innocenti, Matteo L, López‐Gálvez, Gloria, Pettenati, Elisa, Revez, Joana, Vettori, Maria Vittoria, Brozzi, Rosella
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creator Bampidis, Vasileios
Azimonti, Giovanna
Bastos, Maria de Lourdes
Christensen, Henrik
Dusemund, Birgit
Durjava, Mojca
Kouba, Maryline
López‐Alonso, Marta
Puente, Secundino López
Marcon, Francesca
Mayo, Baltasar
Pechová, Alena
Petkova, Mariana
Ramos, Fernando
Sanz, Yolanda
Villa, Roberto Edoardo
Woutersen, Ruud
Prieto, Miguel
Anguita, Montserrat
García‐Cazorla, Yolanda
Innocenti, Matteo L
López‐Gálvez, Gloria
Pettenati, Elisa
Revez, Joana
Vettori, Maria Vittoria
Brozzi, Rosella
description 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 × 109 CFU/kg feed and 6.4 × 108 CFU/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 × 109 CFU/kg complete feed and 6.4 × 108 CFU/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.
doi_str_mv 10.2903/j.efsa.2023.7859
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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 × 109 CFU/kg feed and 6.4 × 108 CFU/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 × 109 CFU/kg complete feed and 6.4 × 108 CFU/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.</description><identifier>ISSN: 1831-4732</identifier><identifier>EISSN: 1831-4732</identifier><identifier>EISSN: 2314-9396</identifier><identifier>DOI: 10.2903/j.efsa.2023.7859</identifier><identifier>PMID: 36895576</identifier><language>eng</language><publisher>United States: John Wiley &amp; Sons, Inc</publisher><subject>Additives ; Animal feed ; Antibiotics ; Antimicrobial agents ; Antimicrobial resistance ; Bacillus paralicheniformis ; Bacillus paralicheniformis DSM 5749 ; Bacillus subtilis ; Bacillus subtilis DSM 5750 ; Bacitracin ; BioPlus® 2B ; Consumers ; Cytotoxicity ; Developmental stages ; Drinking ; Drinking water ; Effectiveness ; efficacy ; Feed additives ; Genomes ; Hogs ; Microorganisms ; QPS ; Safety ; Scientific Opinion ; Suckling behavior ; Swine ; zootechnical additive</subject><ispartof>EFSA journal, 2023-03, Vol.21 (3), p.e07859-n/a</ispartof><rights>2023 European Food Safety Authority. published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.</rights><rights>2023 European Food Safety Authority. 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Hansen A/S)</title><author>Bampidis, Vasileios ; Azimonti, Giovanna ; Bastos, Maria de Lourdes ; Christensen, Henrik ; Dusemund, Birgit ; Durjava, Mojca ; Kouba, Maryline ; López‐Alonso, Marta ; Puente, Secundino López ; Marcon, Francesca ; Mayo, Baltasar ; Pechová, Alena ; Petkova, Mariana ; Ramos, Fernando ; Sanz, Yolanda ; Villa, Roberto Edoardo ; Woutersen, Ruud ; Prieto, Miguel ; Anguita, Montserrat ; García‐Cazorla, Yolanda ; Innocenti, Matteo L ; López‐Gálvez, Gloria ; Pettenati, Elisa ; Revez, Joana ; Vettori, Maria Vittoria ; Brozzi, Rosella</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4909-505fd69a2771d2e8d5defd868db25c7627051784c40b98038d7e74e2837c82373</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Additives</topic><topic>Animal feed</topic><topic>Antibiotics</topic><topic>Antimicrobial agents</topic><topic>Antimicrobial resistance</topic><topic>Bacillus paralicheniformis</topic><topic>Bacillus paralicheniformis DSM 5749</topic><topic>Bacillus subtilis</topic><topic>Bacillus subtilis DSM 5750</topic><topic>Bacitracin</topic><topic>BioPlus® 2B</topic><topic>Consumers</topic><topic>Cytotoxicity</topic><topic>Developmental stages</topic><topic>Drinking</topic><topic>Drinking water</topic><topic>Effectiveness</topic><topic>efficacy</topic><topic>Feed additives</topic><topic>Genomes</topic><topic>Hogs</topic><topic>Microorganisms</topic><topic>QPS</topic><topic>Safety</topic><topic>Scientific Opinion</topic><topic>Suckling behavior</topic><topic>Swine</topic><topic>zootechnical additive</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bampidis, Vasileios</creatorcontrib><creatorcontrib>Azimonti, Giovanna</creatorcontrib><creatorcontrib>Bastos, Maria de Lourdes</creatorcontrib><creatorcontrib>Christensen, Henrik</creatorcontrib><creatorcontrib>Dusemund, Birgit</creatorcontrib><creatorcontrib>Durjava, Mojca</creatorcontrib><creatorcontrib>Kouba, Maryline</creatorcontrib><creatorcontrib>López‐Alonso, Marta</creatorcontrib><creatorcontrib>Puente, Secundino López</creatorcontrib><creatorcontrib>Marcon, Francesca</creatorcontrib><creatorcontrib>Mayo, Baltasar</creatorcontrib><creatorcontrib>Pechová, Alena</creatorcontrib><creatorcontrib>Petkova, Mariana</creatorcontrib><creatorcontrib>Ramos, Fernando</creatorcontrib><creatorcontrib>Sanz, Yolanda</creatorcontrib><creatorcontrib>Villa, Roberto Edoardo</creatorcontrib><creatorcontrib>Woutersen, Ruud</creatorcontrib><creatorcontrib>Prieto, Miguel</creatorcontrib><creatorcontrib>Anguita, Montserrat</creatorcontrib><creatorcontrib>García‐Cazorla, Yolanda</creatorcontrib><creatorcontrib>Innocenti, Matteo L</creatorcontrib><creatorcontrib>López‐Gálvez, Gloria</creatorcontrib><creatorcontrib>Pettenati, Elisa</creatorcontrib><creatorcontrib>Revez, Joana</creatorcontrib><creatorcontrib>Vettori, Maria Vittoria</creatorcontrib><creatorcontrib>Brozzi, Rosella</creatorcontrib><creatorcontrib>EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)</creatorcontrib><creatorcontrib>EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</collection><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Agricultural Science Collection</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>Agricultural &amp; Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central</collection><collection>SciTech Premium Collection</collection><collection>Agriculture Science Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>EFSA journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bampidis, Vasileios</au><au>Azimonti, Giovanna</au><au>Bastos, Maria de Lourdes</au><au>Christensen, Henrik</au><au>Dusemund, Birgit</au><au>Durjava, Mojca</au><au>Kouba, Maryline</au><au>López‐Alonso, Marta</au><au>Puente, Secundino López</au><au>Marcon, Francesca</au><au>Mayo, Baltasar</au><au>Pechová, Alena</au><au>Petkova, Mariana</au><au>Ramos, Fernando</au><au>Sanz, Yolanda</au><au>Villa, Roberto Edoardo</au><au>Woutersen, Ruud</au><au>Prieto, Miguel</au><au>Anguita, Montserrat</au><au>García‐Cazorla, Yolanda</au><au>Innocenti, Matteo L</au><au>López‐Gálvez, Gloria</au><au>Pettenati, Elisa</au><au>Revez, Joana</au><au>Vettori, Maria Vittoria</au><au>Brozzi, Rosella</au><aucorp>EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)</aucorp><aucorp>EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of a feed additive consisting of Bacillus paralicheniformis DSM 5749 and Bacillus subtilis DSM 5750 (BioPlus® 2B) for piglets, calves for fattening and other growing ruminants (Chr. Hansen A/S)</atitle><jtitle>EFSA journal</jtitle><addtitle>EFSA J</addtitle><date>2023-03</date><risdate>2023</risdate><volume>21</volume><issue>3</issue><spage>e07859</spage><epage>n/a</epage><pages>e07859-n/a</pages><issn>1831-4732</issn><eissn>1831-4732</eissn><eissn>2314-9396</eissn><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 × 109 CFU/kg feed and 6.4 × 108 CFU/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 × 109 CFU/kg complete feed and 6.4 × 108 CFU/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.</abstract><cop>United States</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>36895576</pmid><doi>10.2903/j.efsa.2023.7859</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1831-4732
ispartof EFSA journal, 2023-03, Vol.21 (3), p.e07859-n/a
issn 1831-4732
1831-4732
2314-9396
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_399e54c47e554cd7aaacd0155764aaf0
source Open Access: Wiley-Blackwell Open Access Journals; PubMed Central(OA); Publicly Available Content Database
subjects Additives
Animal feed
Antibiotics
Antimicrobial agents
Antimicrobial resistance
Bacillus paralicheniformis
Bacillus paralicheniformis DSM 5749
Bacillus subtilis
Bacillus subtilis DSM 5750
Bacitracin
BioPlus® 2B
Consumers
Cytotoxicity
Developmental stages
Drinking
Drinking water
Effectiveness
efficacy
Feed additives
Genomes
Hogs
Microorganisms
QPS
Safety
Scientific Opinion
Suckling behavior
Swine
zootechnical additive
title Safety and efficacy of a feed additive consisting of Bacillus paralicheniformis DSM 5749 and Bacillus subtilis DSM 5750 (BioPlus® 2B) for piglets, calves for fattening and other growing ruminants (Chr. Hansen A/S)
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