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.)

EFSA Panel on Additives and Products or Substances used in Animal Feed; Vasileios Bampidis; Giovanna Azimonti; Maria de Lourdes Bastos; Henrik Christensen; Birgit Dusemund; Mojca Fašmon Durjava; Maryline Kouba; Marta López‐Alonso; Secundino López Puente; Francesca Marcon; Baltasar Mayo; Alena Pechová; Mariana Petkova; Fernando Ramos; Yolanda Sanz; Roberto Edoardo Villa; Ruud Woutersen; Montserrat Anguita; Jaume Galobart; Jordi Ortuño; Maria Vittoria Vettori; Rosella Brozzi

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.)

2022

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 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.

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