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 avian species (Proteon Pharmaceuticals S.A.)

Published:
Adopted:
EFSA Journal logo
Wiley Online Library

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DOI
https://doi.org/10.2903/j.efsa.2023.7861
Keywords
zootechnical additives, other zootechnical additives, Bafasal®, bacteriophages, safety, efficacy, all avian species
On request from
European Commission
Question Number
EFSA‐Q‐2022‐00196
Panels
Additives and Products or Substances used in Animal Feed
Panel members at the time of adoption
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.

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 to be used as a zootechnical additive (functional group: other zootechnical additives) for all avian species. The additive (tradename Bafasal®) is not currently authorised in the European Union. Bafasal® is intended to be used 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 a previous opinion, the FEEDAP Panel could not conclude on the additive's potential to be irritant or a dermal sensitiser, or on its efficacy for any avian species due to insufficient data. The applicant provided supplementary information to address these data gaps. The new data showed that Bafasal® is not a skin or eye irritant. No conclusions could be drawn on its skin sensitisation potential. The Panel was not in the position to conclude on the efficacy of Bafasal® to improve the zootechnical performance of the target species based on the available data. The additive showed the potential to decrease the counts of two strains of Salmonella Enteritidis in boots swabs and caecal digesta of chickens for fattening. No conclusions could be drawn on the capacity of Bafasal® to reduce the contamination of other Salmonella enterica strains, serovars or other species of Salmonella. The potential of Bafasal® to reduce the Salmonella spp. contamination poultry carcasses and/or the environment is limited. The FEEDAP Panel recommended a post‐market monitoring plan to address the potential selection and spread of resistant variants of Salmonella to Bafasal®.

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