Overall Alliance for Biosolutions calls for a big, bold and enabling Biotech Act II that also prioritises:

- regulatory simplification and harmonisation across the Single Market;

- faster permitting and authorisation procedures;

- technology-neutral framework conditions;

- predictable long-term investment signals;

- active use of regulatory sandboxes as a legislative tool (also on novel food matters);

- and proportionate sustainability requirements that support industrial competitiveness.

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The Alliance stresses the importance of strengthening access to growth capital. While Europe has a strong pipeline of innovative biosolutions companies, many struggle to secure the financing needed to move from demonstration projects to commercial production. The Alliance therefore encourages the EU to develop funding mechanisms that better mobilise private investment and help bridge Europe’s scale-up funding gap.

Finally, the response underlines the need for stronger scale-up conditions, including faster permitting processes, greater regulatory harmonisation, and investments that support the build-out of industrial biomanufacturing capacity. According to the Alliance, Europe’s ability to translate innovation into commercial production will be critical for future competitiveness, resilience, and the green transition.

The Alliance for Biosolutions looks forward to engaging with policymakers as work on the Biotech Act II progresses and will continue advocating for framework conditions that enable biosolutions to scale and succeed in Europe.