Open AccessAssessment of the application for renewal of the authorisation of Calsporin ® ( Bacillus velezensis DSM 15544) as a feed additive for weaned piglets
Author(s) -
Bampidis Vasileios,
Azimonti Giovanna,
Bastos Maria de Lourdes,
Christensen Henrik,
Dusemund Birgit,
Fašmon Durjava Mojca,
Kouba Maryline,
LópezAlonso 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,
TarrésCall Jordi,
Pettenati Elisa
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.6283
Subject(s) - authorization , library science , computer science , computer security
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 velezensis DSM 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 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 the compliance with the other 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 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.