Following the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) recent meeting in Brussels, Proteon Pharmaceuticals is pleased to share a significant development regarding BAFASAL®, our first bacteriophage-based zootechnical feed additive for poultry.
According to the publicly available agenda of the PAFF Committees, the draft Regulation for BAFASAL® was scheduled for a vote by EU Member States on 12–13 May 2025.
We have now been informally notified that the draft received a qualified majority vote and is now entering the next formal steps: translation, adoption by the European Commission, and publication in the Official Journal of the European Union.
Once the final regulatory procedures are completed, the authorisation of BAFASAL® will mark a historic milestone in bacteriophage innovation, becoming the first bacteriophage-based zootechnical feed additive approved for use in poultry across the EU.
“This development represents a defining moment for Proteon and bacteriophage technology,” said Prof. Jarosław Dastych, CEO of Proteon Pharmaceuticals. “It highlights the role of targeted, science-based approaches in addressing major challenges such as food safety and antimicrobial resistance.”
„This breakthrough confirms Proteon’s leadership in innovation and marks the beginning of a broader impact for phage-based solutions in the EU,” commented Łukasz Dziekoński, Member of the Supervisory Board of Proteon Pharmaceuticals.
The forthcoming authorisation follows a detailed scientific evaluation by the European Food Safety Authority (EFSA), which confirmed BAFASAL®’s safety and efficacy in reducing Salmonella Enteritidis contamination when administered via drinking water or liquid complementary for all poultry species (EFSA Journal 2024;22(12):9132).
“This step forward reflects years of dedicated research and regulatory engagement, and demonstrates that phage-based innovations are gaining recognition within the EU framework,” added Dr Małgorzata Stańczyk, Chief Registration & IP Officer of Proteon Pharmaceuticals.
We will share the formal publication once it is released in the Official Journal of the European Union, expected in the coming weeks.
