The European Biotech Act is approaching adoption, and the amendments now before the European Parliament will determine the extent of the Act’s biosecurity safeguards. CLTR has engaged with the Act throughout its development, through our June 2025 response to the Call for Evidence and our November 2025 consultation submission. This paper responds to the amendments tabled by the joint SANT and ITRE committees and to the ENVI and JURI opinions. It sets out where those amendments deliver the recommendations we have made and offers a small number of targeted refinements for the committees to consider.
Our assessment is that the amendments strengthen the Act’s biosecurity provisions while preserving its central goal of a competitive and resilient European biotechnology sector.
Responses to Amendments
- Strengthening Nucleic Acid Synthesis Screening. The amendments substantially strengthen screening provisions by defining sequence screening, requiring the Commission to issue and regularly update guidance, building in standards such as blind testing and third-party audits, and establishing a pathway to harmonised implementation across the Union. We recommend two further steps: a clear deadline for harmonisation, which we suggest should be 18 months from entry into force, and binding minimum performance standards.
- Enhancing the Advisory Group on Biosecurity. The Advisory Group’s mandate is deepened. The amendments widen its remit beyond AI models to the broader set of emerging biotechnological approaches with potential for misuse, connect it to the EU AI Office and other relevant bodies, and tie a qualified alert to a duty on the Commission and Member States to act on the risk identified. We caution against changes that would weaken the group’s ability to issue such an alert.
- Prioritising Biodefence. The amendments establish the EU Biothreat Radar as a pathogen-agnostic, interoperable surveillance mechanism, broaden the biodefence-capability category of high–impact strategic projects, and provide for secure, tiered access by vetted Union actors to advanced AI capabilities in biological applications. We encourage the committees to write explicit biodefence and biosecurity criteria into the funding provisions, and to reject amendments that would separate the civil and defence dimensions of biotechnology.
- Building Manufacturing Resilience. Three changes reinforce the Union’s biomanufacturing base. Supply-chain resilience becomes an objective of strategic projects, security of supply of critical medicines is added to high-impact projects, and a new Advanced Biomanufacturing Technology designation is proposed. We suggest one refinement: the designation would benefit from a built-in biosecurity review and an explicit link to the Advisory Group on Biosecurity, so that novel or AI-enabled manufacturing technologies are assessed for misuse potential as a condition of designation.
Looking Ahead
The amendments represent significant, welcome progress on the biosecurity ambitions CLTR has advocated throughout this process. We look forward to supporting the committees as the Act advances.
Suggested citation
Mahar, Michael. 2026. “Progress on Biosecurity in the European Biotech Act.” The Centre for Long-Term Resilience. https://doi.org/10.71172/v9mt-pb0s
With special thanks to Nicci Schmidt for copy-editing and proofreading.
