Safety and efficacy of the product ColiCure (Escherichia coli) as a feed additive for horses

Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of the product ColiCure, a preparation of Escherichia coli, as a feed additive for horses. The applicant proposes the use of a strain of E. coli to ‘stabilise’ the intestinal flora of horses exposed to stress situations (e.g. following a change of feed or during transport). The contents of one 100 mL bottle containing a minimum of 1 x 1011 CFU is mixed with a small amount of feed and given immediately to an individual horse once a day for three consecutive days. The administration of ColiCure to horses with abnormal faeces for three days significantly improved the rate of return to normal consistency in three studies. In the view of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) this establishes the potential of ColiCure to reduce the risk of gastrointestinal disturbances in horses. Doses up to 100-fold the minimum guaranteed dose did not adversely affect the health of horses given ColiCure for three consecutive days and monitored for a further month. Consequently, the FEEDAP Panel considers the product safe for adult horses when used as proposed. However, as the youngest horse exposed to the product was three years old, the conclusion on safety for young/mature The FEEDAP Panel considers that any hazard for the consumer and the primary hazard for the user would arise mainly from the inadvertent exposure to the live organism. The use of PCR methods and a specific microarray designed to pathotype E. coli showed the absence of the virulence determinants associated with human pathogenic strains in the E. coli strain used in ColiCure. Given the lack of virulence determinants, the limited duration of application of the product to horses and the intended market, the FEEDAP Panel considers any risk to the consumers and the users to be remote. Since E. coli are ubiquitous and since the limited use of the product proposed with horses would not measurably alter the occurrence or concentration of E. coli in the environment, use of ColiCure would not pose a risk for the environment.