Updates

EU Biotech Act and Food and Feed Safety Simplification Omnibus: what’s in it for the food and feed sector?

December 2025 brought two major regulatory proposals from the European Commission: the first part of the EU Biotech Act and the Food and Feed Safety Simplification Omnibus. Together they promise regulatory sandboxes for testing innovative products, a broader advisory role for EFSA, tailored rules for genetically modified micro-organisms, and a move from time-limited to unlimited approvals for substances with proven safety records. For food and feed businesses, that translates into faster market access, lighter administrative burdens and more legal certainty, provided the underlying safety standards keep pace.

Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

Axon helped The Protein Brewery rename its novel food product. We proposed consumer-friendly alternatives to the European Commission, resulting in an approved name the client is very happy with.

As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.

We have advised several clients on the classification of their medical devices, including software products, under the MDR and IVDR, and have helped them in negotiating.

We have advised a start-up on the regulatory qualification and classification of its health application under the MDR, including the determination of whether the software qualifies as a medical device or as a wellness product.

We have assisted a digital health company with its market access and reimbursement strategy for a remote patient monitoring solution in the Netherlands, including advising on the applicable reimbursement pathways and applicable healthcare legislation.

We have advised a telehealth provider on its data processing strategy in connection with the roll-out of a new digital platform, including advising on cross-border data exchange requirements for the provision of digital healthcare services.

We have advised a digital health start-up on the qualification of its services under Dutch healthcare law, including the determination of whether the company qualifies as a healthcare provider and the resulting regulatory obligations.