The EU has spent decades successfully building a world-leading biotechnology research ecosystem. But now, as the Commission is increasingly realising, Europe’s competitiveness depends not only on its ability to innovate, but on its ability to commercialise, scale up and deploy innovation.

That is the ambition underpinning the forthcoming Biotech Act II, and the reason biocontrol should be seen as much more than a niche agricultural policy issue.

Unlike many emerging biotechnologies, biocontrol is not waiting for its paradigm-shifting breakthrough moment. Innovative products are already on the market, companies continue to invest in developing the next generation of solutions, and farmers will soon have access to new tools in their fight against pest and food insecurity.

However, all is not well. Europe actually has fewer approved biocontrol substances than it had a decade ago. A significant number of start-ups have announced that they are no longer pursuing entry into the EU market because investors won’t wait nearly a decade for the first revenue streams.

So, when it comes to deploying European biotech, biocontrol is the canary in the coal mine.

If Europe cannot efficiently deploy one of its most mature, scientifically robust and strategically aligned biotechnologies, it raises uncomfortable questions about its ability to deploy the next generation of biotech writ large. If Europe cannot solve the deployment challenge here, it becomes much harder to argue that Europe is ready to solve it elsewhere.

Biocontrol innovation takes (too many) years to reach the field, and it’s not clear if Omnibus X alone will fix the problem.

The Food and Feed Safety Omnibus X made ambitious proposals to modify Regulation 1107/2009, which governs the authorisation of plant protection products, to help ensure that more safe and effective biocontrol products reach EU farmers in a timely manner. More predictable, proportionate and efficient approval processes are critical if innovative biocontrol solutions are to reach European farmers more quickly. The draft report from the European Parliament, presented by its co-rapporteurs on 6 July, shows that they understand the challenge and support pragmatic solutions. The Council has not yet settled its position.

Indeed, focusing exclusively on Reg. 1107/2009 risks treating the symptom rather than the underlying cause.

The structural problems facing biocontrol are also those that hinder deployment in other biotech sectors: how evidence is generated, shared and assessed; how regulators cooperate across institutions and Member States; how novel technologies are examined; how digital technologies support regulatory processes; and how effectively the unified Single Market functions. Another issue that keeps cropping in discussions around the bioeconomy is that the regulatory siloes based on uses is not aligned with the reality of the bioeconomy, which can be better described as a value web than a value chain.

The Biotech Act II provides the first opportunity to address these horizontal challenges through a genuine, whole-of-system approach to biotech deployment.

A whole-of-system approach recognises that deployment is rarely constrained by a single regulation or regulatory provision. Instead, it depends on how multiple parts of the system interact. The challenge is therefore not simply to improve one legislative instrument, but to modernise the regulatory operating system that underpins them all.

Fortunately, many of the policy tools already exist:

The principle of One Substance, One Assessment (OSOA) recognises that robust scientific evidence should not need to be repeatedly reassessed where a single high-quality scientific assessment can support subsequent regulatory decisions. Better use of scientific expertise allows regulators to focus their resources where they create the greatest value.

Digitalisation offers another opportunity. Digital dossiers, interoperable data systems, improved information sharing between authorities and the intelligent use of digital technologies can reduce administrative burden, improve transparency and accelerate decision-making. Faster administration does not mean weaker science; it means allowing science to move more efficiently through the regulatory system. It also means exploring how AI can help, both by improving procedures but also through innovative treatment of the wealth of empirical data on bio-based substances that can be found in real-world settings, not just in labs.

Adaptive regulatory pathways acknowledge that innovation rarely develops in a perfectly linear fashion. Where appropriate, regulatory systems should be capable of incorporating new evidence over time while maintaining rigorous scientific oversight. The objective is not lower standards, but smarter regulation that evolves alongside innovation.

None of these reforms will transform biotechnology deployment on their own, their value lies in the way they reinforce one another. Together, they represent the foundations of a modern regulatory framework designed for implementation, scale-up and deployment, the benefits of which can extend well beyond biocontrol.

Industrial biotechnology, precision fermentation, synthetic biology and other innovative sectors are increasingly confronting many of the same deployment challenges. How can Europe reduce unnecessary duplication? How can scientific assessments be better shared? How can digital technologies improve regulatory performance? How can innovative companies scale more rapidly within the Single Market? Many of the answers are in the whole-of-system thinking set out above.

Biocontrol is the Commission’s first real opportunity to demonstrate Europe can deliver measurable improvements in biotech deployment.

If Europe can build a regulatory system that allows safe biological crop protection products to move from laboratory to field more quickly, more predictably and without compromising protection goals, it will have done far more than solve a sector-specific challenge. It will have demonstrated that Europe is capable of translating scientific excellence into competitiveness and, across the biotech ecosystem, prepared the ground for more resilient supply chains, sustainable agriculture and economic growth.