The growing political momentum around the European Biotech Act I and Biotech Act II and the urgent need to modernize EU regulation to support innovation in biosolutions, food technology, and biotechnology with regulatory sandboxes as a tool was clearly highlighted during the conversation.  

Participants welcomed the upcoming second Biotech Act (BA2), while stressing the importance of ensuring coherence between BA1 and BA2 and avoiding fragmented regulation.

Several speakers emphasized that the European Commission now appears more committed than ever to accelerating biotech and biosolutions policy. Participants pointed to recent positive signals from Commissioner Stéphane Séjourné and from Commission President Ursula von der Leyen, who is reportedly keen to speed up progress. At the same time, concerns were raised about the division of responsibilities between different Commissioners (DG Sante and DG Grow) and the risk of regulatory inconsistencies, particularly around novel foods.

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Regulatory Sandboxes as a breakthrough tool for innovation in the EU

A central theme throughout the discussion was the potential of regulatory sandboxes. As MEP Morten Løkkegaard stated during the debate: “Sandboxes are a breakthrough in the way we make legislation.” Participants described sandboxes as an important tool for enabling more adaptive regulation, allowing legislators and authorities to learn alongside innovation rather than reacting years later. Several speakers stressed that lawmakers should not be afraid to experiment and test new regulatory approaches to keep pace with scientific development.

Participants repeatedly warned about the consequences of inaction. The risk of “doing nothing” was described as significant, with concerns that Europe is already falling behind the United States and China in biotech innovation, investment, and commercialization. Examples were shared of innovations and investments moving outside Europe due to slow and unpredictable approval processes.

Industry representatives from Novonesis, Tetra Pak, Syngenta, Algiecel and Unibio provided concrete examples of how regulation directly affects innovation and business operations.  

Novonesis described how biosolutions already play a major role in global food production and highlighted the widening gap between what is scientifically possible and what is regulatorily feasible. Examples included innovations to extend yoghurt shelf life naturally through bacteria strains, as well as AI-assisted development of food cultures. However, current legislation is not equipped to handle such advances and called for broader regulatory sandboxes and learning-oriented frameworks.

Tetra Pak added a strong industrial perspective to the debate, emphasizing the need for predictable and harmonized EU frameworks to enable companies to invest in next-generation circular food systems and infrastructure. The company stressed that industry is ready to co-invest, but that Europe needs a more coordinated approach linking circularity, biotechnology and food resilience.

Syngenta highlighted the growing importance of biological crop protection products, biostimulants, and nutrient efficiency technologies, while noting that European farmers have lost access to numerous crop protection solutions since 2019. Slow approval timelines in the EU — often around ten years compared to three years in other markets — were described as a major obstacle, leaving Europe several innovation cycles behind.

Investment and financing were another major theme. Speakers argued that Europe lacks sufficient capital to scale biosolutions companies and that stronger partnerships between large companies and startups are needed. Comparisons were made showing that Europe significantly trails the United States in biotech investment levels. Participants also criticized the deployment of EU funding instruments, noting that some evaluators lack expertise in biosolutions, and suggested allowing more targeted cooperation between private capital and public funding mechanisms.

Throughout the discussion, participants reflected on whether Europe may finally be approaching a broader political mindset shift following the Draghi report and increasing concerns about competitiveness. While there was optimism about the ambitions of the current European Commission, several speakers stressed that agreement on the importance of biotech must now be translated into concrete legislative action.

The discussion concluded with a strong call for action related to the Biotech Act process. Participants emphasized the need to address regulatory barriers already within BA1 rather than postponing solutions to BA2.  

Suggestions included circulating supporting materials widely, pursuing legal clarification, preparing concrete amendment text, and focusing on specific legislative provisions. Speakers agreed that the debate must move from abstract discussions toward practical regulatory fixes that enable innovation while maintaining high safety standards.

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