EU Biotech Act II: second phase of legislation launched in EU

The EU has released the second stage of legislative proposals on biotech that aim to create a competitive and sustainable environment for innovation in this sector by 2040.

The EU Biotech Act I adopted in December 2025 established a framework to boost the health and food biotechnology sector by simplifying regulations, reducing barriers to finance and introducing safeguards for the safe development of new innovations.  

The EU Biotech Act II proposal is all about scaling up biomanufacturing to increase competitiveness in industrial biotechnology. In other words building on the opportunities unlocked in the first Act by supporting the transition to production of new innovations on an industrial scale.

In this article we unpick what biotech innovation is, what Europe’s consumers think about its benefits, how the proposed legislation will support it, and what’s missing – particularly when it comes to the future of food. 

What is biotech innovation? 

A bioeconomy couples advanced manufacturing with renewable biological resources such as plants, animals and micro-organisms to produce a range of goods and services. 

Biotech innovation is the key to building that economy. So far, innovations in biotech are found in every sector: 

• Pharmaceutical cell therapies that can target patients’ specific conditions
• Fashion experimenting with biotextiles made from plant fibres
• Enzyme technology that cleans up production to make everyday products, like detergents greener and more sustainable.
• Cultivated protein: developing novel proteins to increase sustainable food choices  

Europe’s bioeconomy is estimated to have contributed over €3 trillion to the economy in 2022/23 so is well placed to compete globally if the conditions are right. Plus, this type of advanced manufacturing can drive growth of high-quality employment across European regions.

What is biotech innovation and why does it matter to consumers?

A successful, competitive bioeconomy matters to consumers because it can deliver more sustainable products and enhance strategic autonomy by reducing reliance on supplies from outside the EU.

We know consumers want this, particularly for food supplies:

A 2026 Euroconsumers survey found 85% of respondents considered food production and agriculture to be an area where it is highly important for the EU to develop independent capabilities. This was the highest-ranked sector, ahead of pharmaceuticals (82%), renewable energy (75%), and semiconductors (61%).

Another Euroconsumers survey found 46% of consumers across Belgium, Italy, Spain and Portugal actively want the EU to be more proactive in developing biotech innovation in sustainable meat and protein alternatives.  

What is the Biotech Act II aiming for?

Europe currently stands out as the only major global region without a dedicated biomanufacturing strategy, even as competitors like the US, India and China are rapidly scaling their efforts.

There’s a critical gap in the transition from innovation to industrial scale across all sectors, partly due to the regulatory fragmentation and duplication across sectors and Member States which is slowing the deployment of modern biomanufacturing. 

The impact assessment of the Act gathered feedback on proposals to meet the market wide innovation and competitiveness agenda identified by the Draghi report and the Competitiveness Compass initiative by:

• Stimulating lead markets: by targeting fossil‑dependent sectors and introducing mandatory minimum bio‑based content across biomass, waste, CCU inputs and biomanufactured supplies and end products.

• Boosting the supply side: strengthening Europe’s production base through “Made in Europe” measures, regulatory sandboxes to trial new approaches and encouraging a bigger uptake of bio‑based materials and easier access to finance.

Improving investment certainty: by setting and progressively raising minimum bio‑based content thresholds to give companies the confidence to commit to long-term projects.  

• Defining sustainability criteria: by creating clear sustainability standards for industrial biomass use, mirroring the criteria already applied to bioenergy,
• Streamlining EU rules: by speeding up permitting and authorisations and removing regulatory bottlenecks that delay market deployment.

What should the Act do?

Euroconsumers believes innovation should serve people and we want the EU’s biotech ambitions to put consumers at the centre, recognising them as critical and active market participants. 

So far, the policy thinking around what to include in the Act hits some consumer goals by, for example, reducing unnecessary burdens to attract investment and strengthening supply chains.

But more is needed, we want to see more explicit recognition how stronger supply chains will make prices fair and access broad, and how consumer trust can be built and sustained through guarantees of transparency and strong safety standards.

Most importantly, we want to see consumers’ expectations and attitudes around food security and food innovation incorporated into the goals and implementation of the proposed Act. Our research shows clearly: 

• European consumers are worried about food security, supply chain vulnerability and the EU’s competitiveness.
• 40% of households in southern Europe already struggle to afford protein products.
• 46% of respondents were interested in trying ESFA-approved and affordable novel biotech food products, for example cultivated meat.

With these direct insights in mind,we think the Biotech Act II is an opportunity to create the policy conditions for developing consumer food biotechnology. We want to see: 

• The explicit inclusion of food biotechnology, including novel proteins, cultivated meat and precision fermentation, in the scope of Biotech Act II’s industrial instruments, including sandbox provisions, lead market measures and investment support.
• The Commission revisit the exclusion of novel foods from regulatory sandbox provisions. European consumers are open to innovative foods, so excluding these products from sandboxes only delays the access to safe, affordable, sustainable food that consumers are asking for. 
• Stronger levers for consumer affordability: lead market and supply-side scaling measures could include consumer price outcomes as an explicit design criterion. Investment in shared biomanufacturing infrastructure, reduced authorisation costs for SMEs, and open source public R&D conditionality are direct tools to deliver consumer affordability.

Why listening to consumers on biotech matters

The EU Biotech Act II can bridge the gap between lab and production and supply, ensuring that scientific excellence translates into real-world solutions that empower and protect consumers across Europe.

There is much to play for. Without scaling innovation into production, consumers risk losing access to affordable, sustainable biotech-based products, and will miss being part of a competitive economic area which can deliver choice, quality and growth for consumers.

Without listening to consumers’ direct views and real experience, the EU single market will miss a key demand side driver of biotech innovation. This is particularly significant in the food sector which needs to get on a sustainable, secure and affordable footing fast. 

Making policy with consumers and hearing what they are saying can give the developers of the EU’s biotech policy, the confidence to take a bolder step on food innovation and give consumers the innovation, safety and affordability they want.

Read Euroconsumers full response to the Biotech Act II Call for evidence

Read joint position paper on the Biotech Act II