Closing the implementation gap: a harmonised EU framework for synthetic nucleic acid screening and customer...

Synthetic nucleic acid technologies underpin modern biological research and biomanufacturing. However, their growing accessibility through commercial synthesis services, benchtop devices, and AI-assisted design tools creates significant dual-use biosecurity risks. This paper presents a harmonised EU biosecurity screening framework operationalised through the proposed EU Biotech Act I (December 2025), evaluating two complementary control mechanisms: Know Your Customer (KYC) verification and sequence screening against Sequences of Concern (SOC). We find that existing voluntary frameworks leave systematic coverage gaps that binding EU-level obligations, anchored to ISO 20688-2:2024, would substantively address - particularly for smaller providers and benchtop devices. We argue that near-term EU action offers a time-sensitive opportunity to shape global synthetic biology governance before regulatory fragmentation becomes entrenched.