Open AccessSafety and efficacy of Calsporin ® ( Bacillus subtilis DSM 15544) as a feed additive for pigs for fattening
Author(s) -
Rychen Guido,
Aquilina Gabriele,
Azimonti Giovanna,
Bampidis Vasileios,
Bastos Maria de Lourdes,
Bories Georges,
Chesson Andrew,
Cocconcelli Pier Sandro,
Flachowsky Gerhard,
Gropp Jürgen,
Kolar Boris,
Kouba Maryline,
LópezAlonso Marta,
López Puente Secundino,
Mantovani Alberto,
Mayo Baltasar,
Ramos Fernando,
Villa Roberto Edoardo,
Wallace Robert John,
Wester Pieter,
Brozzi Rosella,
Saarela Maria
Publication year - 2018
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.2018.5219
Subject(s) - context (archaeology) , european commission , feed additive , food safety , animal feed , food science , microbiology and biotechnology , european union , strain (injury) , food additive , biology , business , paleontology , anatomy , broiler , economic policy
Following a request from the European Commission, the European Food Safety Authority ( EFSA ) Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Calsporin ® when used in feed for pigs for fattening. The additive contains viable spores of a single strain of Bacillus subtilis . This species is considered by EFSA to be suitable for the Qualified Presumption of Safety ( QPS ) approach to safety assessment. This approach requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of previous opinions and since concerns are not expected from other components of the additive, Calsporin ® is presumed safe for all target species, including pigs, consumers of products derived from animals treated and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in pigs for fattening is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Based on the results of the pooled analysis of four studies, the Panel on additives and products or substances used in animal feed ( FEEDAP ) concludes that Calsporin ® has the potential to improve performance of pigs for fattening at 1.5 × 10 8 CFU /kg feed.