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Following a request from the European Commission, the EFSA 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 Calsporin®when used in feed for sows and piglets. 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, which 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, consumers and the environment. In a previous opinion, the FEEDAP Panel concluded that Calsporin®is not a dermal/ eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. Use of the additive in feed for sows and suckling piglets will not introduce hazards for users not already considered. Three trials performed with sows over a complete reproductive cycle and their offspring showed positive effects on zootechnical parameters of sows and piglets. Therefore, Calsporin®has the potential to improve one or more performance parameters of sows and suckling piglets when supplemented to both sows and suckling piglets at 3 9 108 CFU/kg of complete feedingstuffs. In the view of the FEEDAP Panel, the effects observed can predominantly be traced back to the administration of the additive to pregnant/lactating sows. The proportion of effects which could be related tofeeding supplemented creep feed to suckling piglets cannot be quantified. [ABSTRACT FROM AUTHOR]

Lactobacillus brevis is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony-forming units ( CFU)/kg fresh material. The species L. brevis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the susceptibility to antibiotics of human and veterinary significance. Although identity was established, the strain was found resistant to ampicillin and clindamycin and may pose a risk for the spread of genes coding for resistance to these antibiotics. Therefore, the use of this strain as a silage additive is not considered safe for target animals, and consumers of products from animals fed the treated silage. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Although L. brevis is ubiquitous in the environment, due to its antibiotic resistance, the FEEDAP Panel cannot conclude on the extent of the risk of horizontal gene transfer to other bacteria in the environment. Six studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. After opening and exposure to air, an increase of 3°C over ambient was taken to indicate aerobic deterioration. The additive showed a potential to significantly improve the aerobic stability of silage produced from easy, moderately difficult and difficult to ensile forage at a minimum application rate of 1 × 108 CFU/kg plant material. [ABSTRACT FROM AUTHOR]

The additive B-Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act® should be considered to have the potential to be a respiratory sensitiser. B-Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA 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 Calsporin ® when used in feed for sows and piglets. 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, which 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, consumers and the environment. In a previous opinion, the FEEDAP Panel concluded that Calsporin ® is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. Use of the additive in feed for sows and suckling piglets will not introduce hazards for users not already considered. Three trials performed with sows over a complete reproductive cycle and their offspring showed positive effects on zootechnical parameters of sows and piglets. Therefore, Calsporin ® has the potential to improve one or more performance parameters of sows and suckling piglets when supplemented to both sows and suckling piglets at 3 × 10 8  CFU/kg of complete feedingstuffs. In the view of the FEEDAP Panel, the effects observed can predominantly be traced back to the administration of the additive to pregnant/lactating sows. The proportion of effects which could be related to feeding supplemented creep feed to suckling piglets cannot be quantified., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)