Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Gallinarum B/00111 (Bafasal) for all avian species (Proteon Pharmaceuticals S.A.).

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 feed additive consisting of four bacteriophages infecting Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit-length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panel concluded that Bafasal is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal is safe for the environment. The Panel was not in the position to conclude on the efficacy of Bafasal for any avian species due to insufficient data.