Brussels, October 14, 2025
Today, a coalition of leading organisations from the synthetic biology, biotechnology, and health security communities is launching a joint position paper urging the European Commission to embed harmonised DNA synthesis screening standards in the forthcoming EU Biotech Act.
The joint statement — titled “Joint Position on the EU Biotech Act and Wider Legislative Efforts to Strengthen Europe’s Bioeconomy” — calls for Europe to move from voluntary to enforceable screening practices that protect innovation, reinforce competitiveness, and ensure responsible governance of biotechnology across the EU’s single market.
“Knowing what is being ordered and by whom is essential for safeguarding biotechnology. DNA synthesis screening is not a bureaucratic burden — it’s an enabler of trust, investment, and innovation,” the signatories emphasised.
The statement highlights the need for a phased, enforceable pathway for nucleic acid synthesis screening, built around four pillars:
- Strengthening internationally recognised standards such as ISO 20688-2 and ensuring practical implementation for all providers, including SMEs.
- Promoting universal adoption by linking compliance to licensing, procurement, and EU research funding (Horizon Europe and FP10).
- Enhancing international coordination to align with US, UK, WHO, and ASEAN frameworks.
- Phasing in enforceable and auditable screening standards across the EU single market.
Embedding these measures would make Europe the first global region to codify biosecurity screening into its biotechnology legislation — establishing the EU as a trusted standard-setter for responsible innovation and secure supply chains.
The joint statement was delivered as new scientific evidence underscores the urgency of robust oversight. A recent study, “Strengthening nucleic acid biosecurity screening against generative protein design tools,” published in Science, demonstrated how AI-assisted protein design tools can generate modified sequences that evade existing detection systems, but also how collaborative action with DNA synthesis companies can dramatically improve screening performance through updated algorithms and guidance.
“Europe’s leadership on the Biotech Act provides a rare opportunity to future-proof biosecurity in an era of AI-enabled biology,” according to Sophie Peresson, International Standards Lead at IBBIS. “By embedding robust screening measures, the EU can protect its scientific edge while fostering global trust in European innovation.”
The signatories stand ready to support the European Commission in developing a practical implementation roadmap for screening adoption, ensuring that the Biotech Act delivers both safe innovation and global competitiveness for Europe’s bioeconomy. You can download the statement here. This work has been featured in a tribune in Le Monde.