TY - JOUR

T1 - Safety and efficacy of a feed additive consisting of Bacillus velezensis DSM 15544 (Calsporin®) for dairy cows and other dairy ruminants (Asahi Biocycle Co. Ltd.)

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 - Edoardo Villa, Roberto

AU - Woutersen, Ruud

AU - Anguita, Montserrat

AU - Galobart, Jaume

AU - Ortuño, Jordi

AU - Vittoria Vettori, Maria

AU - Brozzi, Rosella

AU - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

N1 - Publisher Copyright: © 2022 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

PY - 2022

Y1 - 2022

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 Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for dairy cows and other dairy ruminants. The product under assessment is based on viable spores of Bacillus velezensis DSM 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 compliance with the applicable qualifications confirmed. Therefore, B. velezensis DSM 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 FEEDAP Panel is not in the position to conclude on the efficacy of Calsporin® for dairy cows or other dairy ruminants based on the data provided.

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 Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for dairy cows and other dairy ruminants. The product under assessment is based on viable spores of Bacillus velezensis DSM 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 compliance with the applicable qualifications confirmed. Therefore, B. velezensis DSM 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 FEEDAP Panel is not in the position to conclude on the efficacy of Calsporin® for dairy cows or other dairy ruminants based on the data provided.

KW - Bacillus velezensis

KW - Calsporin

KW - efficacy

KW - gut flora stabiliser

KW - QPS

KW - safety

KW - Zootechnical additive

U2 - 10.2903/j.efsa.2022.6984

DO - 10.2903/j.efsa.2022.6984

M3 - Journal article

C2 - 35058989

AN - SCOPUS:85125339025

VL - 20

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 1

M1 - e06984

ER -