Prostora Max is a feed additive based on a strain of Bifidobacterium animalis that has never been authorised in the EU. It is intended to be used in dogs at a proposed dose of 1.0 x 109 colony-forming units (CFUs)/day in the form of a supplemental treat. The species B. animalis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, if its identity is confirmed and the absence of resistance to antibiotics of human and veterinary clinical significance demonstrated. However, the B. animalis strain is resistant to the antibiotic clindamycin. In the view of the FEEDAP Panel the antibiotic resistance qualification of the B. animalis strain has not been met and the QPS approach cannot therefore be applied. Although the applicant, on the basis of a bioinformatic analysis, could exclude the presence of many known antibiotic resistance genes, the genetic basis of the resistance to clindamycin was not established. In the absence of information on the genetic basis of this resistance, the extent of the risk of horizontal gene transfer to other bacteria in the food chain and in the environment cannot be established. All the excipients of the additive are authorised for food or feed use or feed materials. The product is in a tablet form so exposure to the mucous membranes and respiratory system of users is unlikely. Some skin exposure might occur, as the cocoa butter would melt at body temperature, but skin exposure would be limited. Treatment with Prostora Max at least 1 x 109 CFUs/day had an effect on gastrointestinal-related parameters in dogs. In two studies this took the form of an improved faecal score. However, in one study this improvement was marginal and of questionable biological/practical value. Therefore, taking into consideration the results of all three studies assessed, the FEEDAP Panel cannot conclude on the efficacy of Prostora Max for dogs.
