The European Commission’s proposed EU Biotech Act signals a meaningful step toward modernising how biotechnology is regulated in Europe. For companies working with microbial innovation, fermentation, and biomanufacturing, several elements stand out.
The proposal introduces a more proportionate, risk-based approach to genetically modified micro-organisms (GMMs), including a new low-risk category for certain applications in food, feed, and agriculture. EFSA processes are expected to become more predictable, supported by expanded scientific advice and clearer pathways for applicants.
Another notable development is the introduction of regulatory sandboxes, allowing controlled, real-world testing of new biotechnological solutions. These are designed to support innovation and reduce uncertainty, particularly for SMEs.
However, important limitations remain. Regulatory sandboxes will not apply to novel foods, meaning companies developing new food ingredients must still navigate the full authorisation process. Compliance costs remain high, and the practical implementation of the proposals is still evolving.
At Biosafe, our team is following these developments closely in terms of what they mean in practice for safety assessment, dossiers, and timelines. We’ll share more insights as the proposals move forward.
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Read more: Microbial testing – An overview of what it is and what it is for
