The International Biosecurity and Biosafety Initiative for Science (IBBIS) has submitted its official response to the European Commission’s call for evidence on the forthcoming EU Biotech Act, urging decisive action to embed robust biosecurity measures, harmonised standards, and international coordination into Europe’s biotechnology future.

The EU Biotech Act aims to foster a supportive environment for biotechnology innovation across the continent—helping translate scientific breakthroughs into real-world applications while upholding the highest safety standards. IBBIS welcomes this ambition and stresses that the security of the bioeconomy must be treated as a foundational enabler of innovation, not an afterthought.

Drawing on findings from the ongoing IBBIS Global DNA Synthesis Map, the submission reveals that only 15% of synthetic DNA providers currently implement screening for sequences of concern, a major regulatory and security gap. IBBIS highlights that screening is already required under EU export controls but remains inconsistently applied due to fragmented policy and lack of enforceable standards.

IBBIS is calling on the EU to:

1. Strengthen and clarify DNA synthesis screening standards, including through enhancements to ISO 20688-2:2024
2. Support voluntary certification schemes as a transitional tool towards enforceable norms
3. Incentivize compliance through EU funding and procurement mechanisms
4. Phase in mandatory standards aligned with international efforts in the U.S. and U.K.
5. Establish a European Biorisk Expert Group to monitor emerging biosecurity challenges
6. Introduce biosecurity conditionality into EU research and innovation programmes

“Without a harmonised framework, responsible companies face competitive disadvantages and policymakers face blind spots. It’s time for the EU to lead in setting global norms for secure, responsible biotechnology,” said IBBIS Executive Director Dr. Piers Millet. “The Biotech Act offers a unique opportunity to ensure safety and innovation grow hand-in-hand.”

The IBBIS submission is endorsed by leading global stakeholders, including the International Gene Synthesis Consortium (IGSC), the European Synthetic Biology Society, the Pandemic Action Network, and Pour Demain Belgium. The full submission can be downloaded here: Securing Europe’s Biotechnology Future.

IBBIS stands ready to support EU institutions in building the technical, legal, and governance infrastructure needed to operationalise safe and sustainable biotech growth across Europe.

For inquiries about the IBBIS submission to the call for evidence, please contact Sophie Peresson, sophie@ibbis.bio.

Feature image from Ibrahim Khairov on Wikimedia Commons.