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

Abstract

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 ornamental fish. Calsporin® is currently approved as a zootechnical feed additive for use with chickens for fattening and rearing, turkeys, piglets, and minor avian species to point of lay. The additive contains viable spores of a single strain of Bacillus subtilis. This species is considered by the EFSA to be suitable for the qualified presumption of safety approach to establishing safety for target species, consumers and the environment. The additive was found to meet the criteria for this approach in the context of previous opinions and, as a result, is presumed safe for all target species, including ornamental fish. The use of the additive with feed for ornamental fish is considered unlikely to introduce hazards for users of the product not already considered in previous assessments. The minimum dose proposed for use in feed for ornamental fish is 1 × 1010 colony-forming units (CFU)/kg of complete feedingstuff. This application makes reference to a published study describing the effects of adding Calsporin® to the diet of juvenile koi carp (Cyprinus carpio). A significant increase in final body weight and improvement in feed to gain ratio was observed in fish given the additive compared with controls. Since the effect of Calsporin® addition in all of the major species previously examined was an improvement in one or more performance-related parameters, and since the same outcome was observed in koi carp, it can be presumed