Europe's Bioeconomy Challenge: from Strategic Autonomy to cooperative leadership

Europe talks about strategic autonomy as its answer to geopolitical fragmentation and supply-chain dependency — nowhere more than in agriculture, feed, fertilisers and food. But biotechnology and biomanufacturing raise a sharper question, one the Biotech Act I and II agenda has yet to fully confront:

What if strategic autonomy becomes obsolete before it is achieved?

Not because Europe cannot build capacity. Because another jurisdiction may already have set the standards, production models and market expectations that determine how a technology scales globally — and drafting the rules as a second mover is a much weaker position, even for a market as large as Europe's.

Leadership means setting the terms of adoption

In technology-intensive sectors, industrial leadership isn't only about who invents something first. It's about who defines the conditions under which everyone else can adopt, validate, certify, finance and commercialise it at scale. Once a technical or regulatory architecture becomes widespread, switching gets expensive: supply chains adapt to it, testing methods are built around it, investors and regulators come to rely on it. At that point, the standard-setter doesn't need to own every factory. It controls the direction of travel.

Europe has long played this card as the "Brussels effect" — trading a less innovation-friendly environment for outsized regulatory influence. But that trade assumes regulators can afford to take their time. When markets move fast, a multi-year approval queue isn't a safety margin; it's a way of losing the market.

China is the clearest illustration. Its 15th Five-Year Plan (2026–2030) names biomanufacturing and biomedicine as strategic growth industries — not as a research question, but as an industrialisation challenge. The test for Europe isn't whether it has world-class universities and start-ups; it does. The test is whether it can move science through innovation, regulatory acceptance, investment, manufacturing and market adoption fast enough to compete with jurisdictions built to run that pipeline at speed.

The Commission recognises the gap. The European Biotech Act (December 2025) and the new Bioeconomy Strategy both target investment, manufacturing capacity and regulatory friction. The uncomfortable question they raise: is Europe moving fast enough to shape the markets it wants to lead, or only to regulate markets that get shaped elsewhere?

Regulation is industrial infrastructure, not just a constraint

Food and feed regulation shows both sides of this coin clearly.

Novel Foods is the positive case. Regulation (EU) 2015/2283 built a centralised authorisation system and a Union list of approved products, usable EU-wide once authorised. That's not a one-off administrative decision — it's market infrastructure. And the frontier is moving straight into this space, with a growing share of applications involving fermentation-derived products and novel microorganisms.

Animal by-products show the cost of the alternative. The EU generates over 20 million tonnes of by-products a year, many with real nutritional or energetic value that current rules constrain for legitimate health reasons. The "end point" provision — the point at which a processed material stops being an animal by-product and can enter another regulatory system, such as fertilisers or biofuels — is the hinge. Where regulation can establish a credible end point, waste becomes feedstock. Where it can't, material stays trapped in its category even when the technology to process it safely already exists. The real question isn't just "is this material safe?" — it's whether the system can build a credible pathway from waste stream to industrial resource.

Insect protein in feed is the cautionary tale. The EU authorised processed insect protein for aquaculture in 2017, and the rules evolved as evidence expanded. Authorisation opened a market — but authorisation alone doesn't build an industry. That takes capital, feedstock, processing capacity and predictable rules working together. The chain — evidence, risk assessment, authorisation, investment, capacity, demand — has to move as a system, not stall at any single link.

The real strategic asset is standards

Europe has repeatedly exported its regulatory models in food safety, chemicals, data protection and environmental rules. That mechanism can't be taken for granted in emerging technology. The first jurisdiction to establish a workable package of technical standards, testing methodologies, traceability systems, certification and market-access conditions gains an advantage that's hard to reverse later.

That's why standards can matter more than sovereignty over individual factories. A European company can manufacture in Europe and still depend on protocols, equipment standards or certification systems set elsewhere. That's a quieter, less visible form of dependency — and a more durable one.

Neither cooperation nor containment

China and Europe shouldn't be framed only as partners or rivals. Both framings are too simple. The real question is where to cooperate, where to compete, and where Europe needs to set its own technical and regulatory standards outright. Scientific research, food systems, biodiversity and climate technology are natural areas for cooperation. But cooperation should never mean outsourcing the ability to define the future market — and the EU's own posture, pursuing research cooperation while building independent industrial capacity, already reflects that distinction.

From strategic autonomy to strategic agency

Europe needs to move past the language of autonomy, which implies doing everything alone — neither realistic nor necessary. The sharper goal is strategic agency: the capacity to shape the technological, regulatory and industrial conditions under which Europe, and potentially the wider global market, evolves. That means deciding which technologies to scale, which standards will govern them, how fast regulation can move without compromising protection, and where domestic capacity actually matters versus where interdependence is fine.

This is especially urgent for food, feed and the bioeconomy, where the next wave — fermentation-derived ingredients, alternative proteins, microbial biomass, side-stream valorisation, bio-based materials — will keep blurring existing regulatory categories. Increasingly, the regulatory system won't just decide whether an innovation is safe. It will decide whether it becomes an industry.

Europe isn't starting from zero. It has one of the world's largest integrated markets, strong science, and mature risk-assessment institutions. What's missing is scale — and scale can't be bolted on at the end of the pipeline; it has to be designed in from the start.

For regulatory affairs professionals, that reframes the job. The question isn't "how do we regulate this new technology?" It's "how do we regulate it so that Europe protects consumers, animals and the environment and stays able to shape the market this technology will create?"

That's the harder question. In the next wave of biotechnology, the jurisdictions that write the rules of scale may matter as much as the ones that own the factories. Europe's challenge isn't simply to achieve autonomy - it's to keep the agency to shape the future before someone else has already scaled it.