The European Union has officially approved Proteon Pharmaceuticals’ bacteriophage-based additive, BAFASAL®, for use in poultry feed. The decision marks a major milestone for phage technology in animal nutrition.
Proteon Pharmaceuticals’ bacteriophage-based feed additive BAFASAL® has received full regulatory approval from the European Union for use in poultry.
This decision has now been formally adopted and published in the Official Journal of the European Union, and the new regulation entered into force on 15 July, 2025. Highlighting this groundbreaking step for the European poultry sector, the company states that the decision is paving the way for broader use of feed additives based on phage technology in everyday farming practice.
Bacteriophages, as natural viruses specifically targeting harmful bacteria, represent a safe, precise, and innovative alternative to traditional methods of combating bacterial threats in animal production. As antibiotic resistance grows, phage technology is gaining renewed attention as a precise and sustainable solution in livestock production.
REGULATORY PATHWAY TO EU AUTHORISATION
The authorisation of BAFASAL® in the European Union followed a rigorous, multi-phase regulatory process under Regulation (EC) No 1831/2003, which governs the approval of feed additives. Proteon Pharmaceuticals reveals it submitted a comprehensive dossier to the European Food Safety Authority (EFSA), providing extensive data on the product’s safety, efficacy, and manufacturing quality. EFSA’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) conducted a thorough scientific assessment, concluding that BAFASAL® is safe for all poultry species, consumers, and the environment. The Panel also recognised its potential to reduce Salmonella Enteritidis contamination when administered via drinking water or liquid complementary feed.
Based on the latest positive opinion of EFSA, the European Commission, in agreement with the Member States within the Standing Committee on Plants, Animals, Food and Feed (PAFF), voted in mid-May of 2025 to authorise the product for market placement. In recent days, the formal adoption and publication of the authorisation in the Official Journal of the European Union has officially permitted the use of BAFASAL® across all EU Member States.
“This decision affirms our long-standing belief in the potential of bacteriophages,” said Professor Jarosław Dastych, CEO of Proteon Pharmaceuticals. “We’re proud to deliver a tool that supports safer food, healthier animals, and a more sustainable approach to poultry production.”
GLOBAL PROSPECTS FOR BAFASAL®
The EU authorisation of BAFASAL® marks an important step towards broader international adoption, the company states. The product is already registered in India and Brazil, with regulatory approval processes ongoing in several other countries.
According to the announcement, BAFASAL® is a liquid zootechnical feed additive composed of carefully selected bacteriophages developed to reduce the presence of Salmonella Enteritidis in poultry production. It acts selectively, targeting pathogens while supporting a balanced gut microbiota. Administered via drinking water, it integrates easily into standard farming practices.
BAFASAL® is gaining recognition as a modern and effective solution for poultry producers, enabling a more precise, microbiome-friendly approach to flock health management. Proteon Pharmaceuticals points out that it can also support strategies aimed at reducing or optimising the use of antibiotics, aligning with the goals of sustainable animal production.
Regarding the approval, the company stated, “The Proteon Pharmaceuticals team has contributed significantly to the scientific understanding of BAFASAL® through peer-reviewed academic publications. We invite you to review several of our key studies dedicated to BAFASAL®, available in the journal Viruses. In 2021, we published ‘Examining the effects of an anti-Salmonella bacteriophage preparation, BAFASAL®, on ex vivo human gut microbiome composition and function using a multi-omics approach’, which explores the impact of BAFASAL® on the human gut microbiome using advanced multi-omics techniques. Additionally, our 2020 publication, ‘Comprehensive Evaluation of the Safety and Efficacy of BAFASAL® Bacteriophage Preparation for the Reduction of Salmonella in the Food Chain’, offers a thorough assessment of BAFASAL®’s safety and effectiveness in reducing Salmonella throughout the food production process. These studies underscore our commitment to scientific excellence and transparency in developing innovative bacteriophage-based solutions.”
