Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is inten...

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Main Authors: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Rosella Brozzi, Matteo L. Innocenti, Jordi Ortuño, Piera Valeri, Yolanda García‐Cazorla
Format: Article
Language:English
Published: Wiley 2024-11-01
Series:EFSA Journal
Subjects:
Online Access:https://doi.org/10.2903/j.efsa.2024.9070
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author EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Montserrat Anguita
Nicole Bozzi Cionci
Rosella Brozzi
Matteo L. Innocenti
Jordi Ortuño
Piera Valeri
Yolanda García‐Cazorla
author_facet EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Montserrat Anguita
Nicole Bozzi Cionci
Rosella Brozzi
Matteo L. Innocenti
Jordi Ortuño
Piera Valeri
Yolanda García‐Cazorla
author_sort EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
collection DOAJ
description Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%–65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%–65%.
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spelling doaj-art-d055a1499f9f43c28be2091b2d3b28f42025-08-20T03:41:52ZengWileyEFSA Journal1831-47322024-11-012211n/an/a10.2903/j.efsa.2024.9070Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Roberto Edoardo VillaGiovanna AzimontiEleftherios BonosHenrik ChristensenMojca DurjavaBirgit DusemundRonette GehringBoet GlandorfMaryline KoubaMarta López‐AlonsoFrancesca MarconCarlo NebbiaAlena PechováMiguel Prieto‐MaradonaIlen RöheKaterina TheodoridouMontserrat AnguitaNicole Bozzi CionciRosella BrozziMatteo L. InnocentiJordi OrtuñoPiera ValeriYolanda García‐CazorlaAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%–65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%–65%.https://doi.org/10.2903/j.efsa.2024.9070Bacillus subtilis DSM 33862efficacyLentilactobacillus buchneri DSM 12856QPSsafetysilage additive
spellingShingle EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Roberto Edoardo Villa
Giovanna Azimonti
Eleftherios Bonos
Henrik Christensen
Mojca Durjava
Birgit Dusemund
Ronette Gehring
Boet Glandorf
Maryline Kouba
Marta López‐Alonso
Francesca Marcon
Carlo Nebbia
Alena Pechová
Miguel Prieto‐Maradona
Ilen Röhe
Katerina Theodoridou
Montserrat Anguita
Nicole Bozzi Cionci
Rosella Brozzi
Matteo L. Innocenti
Jordi Ortuño
Piera Valeri
Yolanda García‐Cazorla
Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
EFSA Journal
Bacillus subtilis DSM 33862
efficacy
Lentilactobacillus buchneri DSM 12856
QPS
safety
silage additive
title Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
title_full Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
title_fullStr Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
title_full_unstemmed Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
title_short Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG)
title_sort safety and efficacy of a feed additive consisting of bacillus subtilis dsm 33862 and lentilactobacillus buchneri dsm 12856 as a silage additive for all animal species lactosan gmbh co kg
topic Bacillus subtilis DSM 33862
efficacy
Lentilactobacillus buchneri DSM 12856
QPS
safety
silage additive
url https://doi.org/10.2903/j.efsa.2024.9070
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