Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) as a feed additive for laying hens and avian species for laying

Abstract

The additive Calsporin ® is a preparation containing viable spores of a single strain of Bacillus subtilis.The product was previously assessed by the European Food Safety Authority and is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds. The present application is for an extension of use in feed for laying hens and minor avian species for laying and for game, sporting and ornamental birds for laying. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, as judged by the current guidelines. Thus the conclusion reached in previous opinions that this strain of B. subtilis is presumed safe for target animals, consumers and the environment is still considered valid. This conclusion automatically covers the use of the additive in feed for laying hens and for all avian species for laying. Use of the additive in feed for laying hens and for all avian species for laying will not introduce hazards for users not already considered. In the three trials conducted with laying hens the amount of feed needed to produce a unit of egg mass was significantly reduced when Calsporin ® was included at the minimum recommended dose of 3 × 10 8 colony-forming units per kilogram of feed. While the Panel notes that one of the studies involved layers in the second half of production rather than from the onset of laying, the positive outcome is taken to indicate a potential for efficacy over the entire laying period. This conclusion on efficacy for laying hens can be extended to all avian species for laying when the additive is used at the same minimum dose.

Assessment of the application for renewal of authorisation of Calsporin® (Bacillus subtilis DSM 15544) for chickens for fattening

“…14 The PFGE patterns of the strain isolated from one batch of the product from 2015 were identical to those from the strain deposited (DSM 15544), confirming that the strain has not been modified overtime. 15 Susceptibility to relevant antibiotics and lack of toxigenic potential were demonstrated in a recent opinion (EFSA FEEDAP Panel, 2015a) and are considered still valid.…”

“…been modified overtime. 15 Susceptibility to relevant antibiotics and lack of toxigenic potential were demonstrated in a recent opinion (EFSA FEEDAP Panel, 2015a) and are considered still valid.…”

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) as a feed additive for dogs

“…Calsporin ® is a dry free-flowing powder with a minimum declared content of 1 9 10 10 colony-forming units (CFU) of Bacillus subtilis DSM 15544 10 per gram of additive. It has the same formulation and method of manufacture as that considered in previous opinions (EFSA, 2006;EFSA FEEDAP Panel, 2010a,b;EFSA FEEDAP Panel, 2015a). Thus, the data pertaining to impurities, physical properties and shelf-life assessed in these opinions still apply.…”

Safety and efficacy of Calsporin® (Bacillus subtilis DSM 15544) for all poultry species

“…This approach requires the identity of the active agent to be established and the absence of a toxigenic potential and susceptibility to antibiotics of human clinical and veterinary importance to be demonstrated. The identity of the strain Calsporin ® (Bacillus subtilis DSM 15544) was established and the lack of resistance to relevant antibiotics and of toxigenic potential was demonstrated in a previous assessment (EFSA FEEDAP Panel, 2015a). Accordingly, this strain is considered by EFSA to be suitable for the QPS approach to safety and the additive is presumed safe for the target species, consumers and for the environment.…”