Safety of a feed additive consisting of Duddingtonia flagrans NCIMB 30336 (BioWorma®) for all grazing animals (International Animal Health Products Pty Ltd)

Abstract

Following 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 of a feed additive consisting of Duddingtonia flagrans NCIMB 30336 (BioWorma®) for all grazing animals other than dairy bovines, ovines and caprines (namely, grazing animals from the following species: pigs (all categories), rabbits (all categories), horses (all categories) and calves/kids of species in the family Cervidae (deer, etc.) and Camelidae (alpacas, etc)). The safety and efficacy of the additive have already been assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the grazing animals other than dairy bovines, ovines and caprines due to the limitations in the dataset provided. For the current assessment, the applicant referred to the sub-chronic oral toxicity study provided in the previous application. The Panel considered that, since the microorganism is provided in the form of chlamydospores and is very unlikely to germinate during the gastrointestinal passage, the results from the sub-chronic oral toxicity study can be used to support the safety of the additive for the target species. Based on the NOAEL derived from the sub-chronic oral toxicity study, the maximum safe levels calculated are higher than the intake levels, resulting from the recommended use level for all the species. Therefore, the Panel concludes that the additive is safe for all grazing bovines, ovines, caprines, rabbits, horses, cervids, camelids and porcine species at the proposed conditions of use.