Guidance on the assessment of the toxigenic potential of Bacillus species used in animal nutrition

Feed, EFSA Panel on Additives and Products or Substances used in Animal

doi:10.2903/j.efsa.2014.3665

Cited by 43 publications

(37 citation statements)

References 34 publications

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“…EFSA considered these issues in its opinion on the safety and efficacy of Bacillus subtilis PB6 as a feed additive for chickens for fattening (EFSA FEEDAP Panel, 2009) following the provisions of the guidance applicable at the time and concluded that the strain could be presumed safe for the target species, consumers and the environment. Subsequently, EFSA has introduced new guidance on the determination of antibiotic susceptibility (EFSA FEEDAP Panel, 2012b) and assessing the toxigenic potential of Bacillus species (EFSA FEEDAP Panel, 2014). Consequently, these elements of the previous assessment are reconsidered in this opinion.…”

Section: Introductionmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy ofBacillus subtilisPB6 (Bacillus subtilis) as a feed additive for laying hens and minor poultry species for laying

Feed¹

2015

EFSA Journal

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European Food Safety Authority (EFSA), Parma, Italy ABSTRACTBacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. This approach requires the identity of the active agent to be established and the absence of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance to be demonstrated. No evidence of toxigenic potential or of resistance to antibiotics of human and veterinary importance was found as judged by the current guidelines. Consequently, the strain of B. subtilis in the additive is presumed safe for target animals, consumers and the environment. This conclusion covers the use of the additive in feed for laying hens and minor poultry species for laying. Use of the additive in feed for laying hens and minor poultry species will not introduce hazards for users not already considered. All four trials made with laying hens showed some evidence of a beneficial effect of the additive on egg production when used at a minimum dose of 1 × 10 8 colony-forming units (CFU)/kg complete feed, by increasing laying rate or average egg weight. The FEEDAP Panel concludes that Bacillus subtilis PB6 shows some potential to be efficacious in laying hens. This conclusion on efficacy for laying hens can be extended to minor poultry species raised for laying when the additive is used at the same minimum dose. SUMMARYFollowing 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 safety and efficacy of the product Bacillus subtilis PB6 as feed additive for laying hens and minor poultry species for laying. Bacillus subtilis PB6 is the trade name for a feed additive based on viable spores of a strain of Bacillus subtilis. The product is intended for use in feed for laying hens and minor poultry species for laying at a dose of 1 × 10 8 CFU/kg complete feedingstuffs.B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety for the target species, consumers and the environment. This approach requires the identity of the active agent to be established and the absence of toxigenic potential and susceptibility to a selected range of antibiotics to be demonstrated. No evidence of a toxigenic potential or resistance to antibiotics of human and veterinary importance was found as judged by the current guidelines. Consequently, the strain of B. subtilis in the additive is presumed safe for target animals, consumers and the environment. This conclusion covers the use of the additive in feed for laying hens and minor poultry species for laying.Use of the additive in feed for laying hens and minor poultry species will not introduce hazards for users not already considered.All four trials made with laying hens showed some evidence of a beneficial effe...

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Section: Introductionmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy ofBacillus subtilisPB6 (Bacillus subtilis) as a feed additive for laying hens and minor poultry species for laying

Feed¹

2015

EFSA Journal

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“…EFSA considered these issues in its opinion on the safety and efficacy of Calsporin ® as a feed additive for weaned piglets (EFSA FEEDAP Panel, 2010a), following the provisions of the guidance applicable at the time, and concluded that the strain could be presumed safe for the target species, consumers and the environment. Subsequently, EFSA has introduced new guidance on the determination of antibiotic susceptibility (EFSA FEEDAP Panel, 2012) the toxigenic potential of Bacillus species (EFSA FEEDAP Panel, 2014). Consequently, these elements of the previous assessment are reconsidered in this opinion.…”

Section: Additional Informationmentioning

confidence: 99%

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

2015

EFS2

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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.

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“…EFSA considered these issues in its opinion on the safety and efficacy of Bacillus subtilis PB6 as a feed additive for chickens for fattening (EFSA FEEDAP Panel, 2009) using the guidance applicable at the time and concluded that the strain could be presumed safe for the target species, consumers and the environment. Subsequently, EFSA introduced new guidance on the determination of antibiotic susceptibility (EFSA FEEDAP Panel, 2012b) and assessing the toxigenic potential of Bacillus species (EFSA FEEDAP Panel, 2014). These issues were reconsidered taking account of the latest guidance in the context of an Opinion on an extension of use for laying hens and minor laying poultry birds (EFSA FEEDAP Panel, 2015).…”

Section: Safetymentioning

confidence: 99%

Safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis ATCC PTA‐6737) as a feed additive for sows

Additives¹,

Rychen²,

Aquilina³

et al. 2017

EFS2

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Bacillus subtilis PB6 is a feed additive based on viable spores of a strain of Bacillus subtilis. EFSA has already issued several opinions on the safety and efficacy of the additive when used in the feed for a number of avian and porcine species/categories. The applicant is now seeking authorisation for use in sows in order to have benefits in piglets. In the course of previous assessments, no evidence of a toxigenic potential or resistance to relevant antibiotics was found. Consequently, the strain of B. subtilis in the additive, following the qualified presumption of safety approach to safety assessment, is presumed safe for target animals including sows and their offspring, consumers and the environment. In a previous assessment, it was also concluded that the additive is not a skin/eye irritant or a skin sensitiser and that there were no concerns on respiratory sensitisation. The use of the additive with feed for sows is considered unlikely to introduce hazards for users of the product not already considered. Five studies are described in which groups of sows given the additive for a minimum period from the last 3 weeks of pregnancy, throughout farrowing and lactation, until weaning of piglets were compared with a control group. In only two of five studies, there was a significant beneficial effect seen in terms of piglet performance. However, when data from the four similar were pooled and analysed, significant increases in weaned weight and average daily gain were indicated for piglets from sows given the additive. Consequently, the FEEDAP Panel concludes that Bacillus subtilis PB6 when added to diets of sows from 3 weeks before parturition until weaning of piglets at a dose of 1 9 10 8 CFU/kg complete feed has the potential to improve the growth of piglets from birth to weaning.

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Guidance on the assessment of the toxigenic potential of Bacillus species used in animal nutrition

Cited by 43 publications

References 34 publications

Scientific Opinion on the safety and efficacy ofBacillus subtilisPB6 (Bacillus subtilis) as a feed additive for laying hens and minor poultry species for laying

Scientific Opinion on the safety and efficacy ofBacillus subtilisPB6 (Bacillus subtilis) as a feed additive for laying hens and minor poultry species for laying

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

Safety and efficacy of Bacillus subtilis PB6 (Bacillus subtilis ATCC PTA‐6737) as a feed additive for sows

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