Safety and efficacy of a feed additive consisting of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (Bafasal®) for all poultry (Proteon Pharmaceuticals S.A.)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting Salmonella enterica ser. Gallinarum B/00111, intended for be as a zootechnical additive (functional group: other zootechnical additives) for all poultry species. Bafasal® is proposed for use in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 10⁶ PFU/bird, to reduce the Salmonella spp. contamination of poultry carcasses and load in the environment, and to improve the zootechnical performance of the treated animals. In previous opinions, the FEEDAP Panel concluded that Bafasal® is safe for the target species, consumers and the environment and is not a skin or eye irritant but should be considered a respiratory sensitiser. No conclusion could be drawn on its dermal sensitisation potential. The additive showed the potential to decrease the counts of two Salmonella Enteritidis strains in boots swabs and caecal digesta of chickens for fattening. However, the Panel was not in the position to conclude on the capacity of Bafasal® to improve the zootechnical performance of poultry, to reduce the contamination of other Salmonella enterica strains, serovars or other Salmonella spp. in chickens, or to reduce the Salmonella spp. contamination of poultry other than chickens. In the current application, the claim on zootechnical performance has been withdrawn. Bafasal® is not a skin or eye irritant but should be considered a potential skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. Based on the new data provided, the Panel concluded that Bafasal® has the potential to reduce the environmental contamination with S. Enteritidis when used in feed and water for all poultry species. No conclusions could be drawn on the effects of the additive on other Salmonella serotypes.