Assessment of the application for renewal of the authorisation of Calsporin® (Bacillus velezensisDSM 15544) as a feed additive for weaned piglets
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Assessment of the application for renewal of the authorisation of Calsporin® (Bacillus velezensisDSM 15544) as a feed additive for weaned piglets. / Bampidis, Vasileios; Azimonti, Giovanna; Bastos, Maria de Lourdes; Christensen, Henrik; Dusemund, Birgit; Fašmon Durjava, Mojca; Kouba, Maryline; López-Alonso, Marta; López Puente, Secundino; Marcon, Francesca; Mayo, Baltasar; Pechová, Alena; Petkova, Mariana; Ramos, Fernando; Sanz, Yolanda; Villa, Roberto Edoardo; Woutersen, Ruud; Cocconcelli, Pier Sandro; Glandorf, Boet; Herman, Lieve; Maradona, Miguel Prieto; Saarela, Maria; Anguita, Montserrat; Galobart, Jaume; Holczknecht, Orsolya; Manini, Paola; Pizzo, Fabiola; Tarrés-Call, Jordi; Pettenati, Elisa; EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP).
I: EFSA Journal, Bind 18, Nr. 11, e06283, 2020.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning
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TY - JOUR
T1 - Assessment of the application for renewal of the authorisation of Calsporin® (Bacillus velezensisDSM 15544) as a feed additive for weaned piglets
AU - Bampidis, Vasileios
AU - Azimonti, Giovanna
AU - Bastos, Maria de Lourdes
AU - Christensen, Henrik
AU - Dusemund, Birgit
AU - Fašmon Durjava, Mojca
AU - Kouba, Maryline
AU - López-Alonso, Marta
AU - López Puente, Secundino
AU - Marcon, Francesca
AU - Mayo, Baltasar
AU - Pechová, Alena
AU - Petkova, Mariana
AU - Ramos, Fernando
AU - Sanz, Yolanda
AU - Villa, Roberto Edoardo
AU - Woutersen, Ruud
AU - Cocconcelli, Pier Sandro
AU - Glandorf, Boet
AU - Herman, Lieve
AU - Maradona, Miguel Prieto
AU - Saarela, Maria
AU - Anguita, Montserrat
AU - Galobart, Jaume
AU - Holczknecht, Orsolya
AU - Manini, Paola
AU - Pizzo, Fabiola
AU - Tarrés-Call, Jordi
AU - Pettenati, Elisa
AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
PY - 2020
Y1 - 2020
N2 - 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 assessment of the application for renewal of authorisation of Calsporin® (Bacillus velezensisDSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensisDSM 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 the compliance with the other qualifications confirmed. Therefore, B. velezensisDSM 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® 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 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.
AB - 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 assessment of the application for renewal of authorisation of Calsporin® (Bacillus velezensisDSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensisDSM 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 the compliance with the other qualifications confirmed. Therefore, B. velezensisDSM 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® 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 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.
KW - Bacillus velezensis
KW - gut flora stabiliser
KW - safety
KW - weaned piglets
KW - Zootechnical additive
U2 - 10.2903/j.efsa.2020.6283
DO - 10.2903/j.efsa.2020.6283
M3 - Journal article
C2 - 33209150
AN - SCOPUS:85097062771
VL - 18
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 11
M1 - e06283
ER -
ID: 259989931