The additive Oralin® is a preparation containing viable cells of a single strain of Enterococcus faecium. It is currently authorised for use in calves, piglets, chickens for fattening, turkeys for fattening and dogs. The applicant is now requesting the authorisation of the additive when used for cats at a minimum dose of 1 x 109 and a maximum dose of 1 x 1010 colony-forming units (CFU)/kg feed. Safety of the additive for the target species at the proposed dose range was shown by the results of a tolerance study in which no adverse effects were seen when a 100-fold overdose of the maximum recommended dose of the additive was administered to cats. Oralin® is not irritant to skin or eyes or a skin sensitiser. The dusting potential of the preparation tested indicated that moderate exposure of users/owners to the dust from the additive is possible. Considering this together with the proteinaceous nature of its active agent, the FEEDAP Panel concludes that the additive should be treated as a respiratory sensitiser. Three studies showed a limited but significant improvement of faecal scores in Oralin®-treated animals. However, such limited improvement in faecal scores is questionable in terms of biological relevance.
