EU approves first-ever bacteriophage-based feed additive for poultry

EUROPE – The European Union has officially approved BAFASAL®, a bacteriophage-based feed additive developed by Proteon Pharmaceuticals, for use in poultry. 

The approval, which took effect on July 15, 2025, marks a significant regulatory breakthrough for phage technology in livestock production across all EU Member States.

The European Commission’s decision, now published in the Official Journal of the European Union, makes BAFASAL® the first product of its kind to receive full EU authorisation under Regulation (EC) No 1831/2003, which governs feed additive approvals.

New era in poultry health

Bacteriophages, natural viruses that selectively target and kill harmful bacteria, offer a precision-based alternative to traditional antibiotics, especially as antimicrobial resistance continues to pose significant global challenges. 

Proteon Pharmaceuticals has long advocated for phage-based tools to improve animal health and food safety, and this EU endorsement significantly validates the company’s scientific efforts.

“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.”

The EU approval followed a rigorous multi-phase review by the European Food Safety Authority (EFSA). 

The agency’s Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) determined that BAFASAL® is safe for all poultry species, consumers, and the environment. 

It also acknowledged the additive’s efficacy in reducing Salmonella Enteritidis contamination when administered via drinking water or as a liquid complementary feed.

Global implications and scientific credibility

The product is already registered in India and Brazil, with additional regulatory submissions underway in several other countries. The EU authorisation is expected to facilitate broader international adoption of phage-based feed solutions.

BAFASAL® is a liquid zootechnical feed additive composed of selected bacteriophages developed to reduce Salmonella Enteritidis in poultry.

By targeting only the harmful bacteria and sparing beneficial microbes, it supports a balanced gut microbiota, helping poultry producers shift toward a more sustainable and microbiome-friendly health management strategy.

Its mode of administration, via drinking water, makes it easily compatible with existing farm systems.

Proteon Pharmaceuticals emphasised its scientific transparency, referencing several peer-reviewed studies demonstrating the product’s safety and efficacy. 

“The Proteon Pharmaceuticals team has contributed significantly to the scientific understanding of BAFASAL® through peer-reviewed academic publications,” the company noted, citing research published in Viruses in 2020 and 2021.

In one such study, BAFASAL®’s impact on the human gut microbiome was examined using multi-omics techniques, while another provided a comprehensive evaluation of the additive’s safety and effectiveness across the food production chain.

With the EU’s formal green light, BAFASAL® is set to become a cornerstone in the transition toward antibiotic alternatives in poultry farming. 

As sustainability and food safety remain at the forefront of regulatory and consumer concerns, bacteriophage-based solutions like BAFASAL® may soon become an integral part of mainstream animal production.

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