Introduction: A mandate for leadership, competitiveness and resilience

The EU is at a critical moment in time, with a need to deliver on political ambitions to build economic strength and resilience now. Europe must anchor and grow its innovation to industrial scale and create a fertile ecosystem for global investment into capacity and supply chains. The 2024 Draghi and Letta reports created a clear direction for EU advancement.

Industrial biotechnology is a critical technology for the EU, building competitive positioning amidst a rapid global shift towards biomanufacturing and establishing flexible production capacity. It strengthens, simplifies and shortens complex global supply chains across sectors. It also reduces reliance on external factors and actors and enables the development of de-fossilised (low carbon), regenerative and circular products in line with Green Deal goals. Most compellingly, it can deliver the scale required for this rapidly, building from Europe’s significant biotechnology foundation within research and industry.

With a cluster of over 25 legislations and initiatives that are directly relevant to biotechnology, the current EU mandate period to 2029 offers the opportunity to deliver an industrial framework for biotechnology from which strong and diverse outcomes can be achieved. Headlines include the EU Biotechnology Act in addition to the Bioeconomy and Life Science Strategies.

This presents the opportunity to amplify European leadership for the transformation of innovation into biomanufacturing, and the EFIB Brussels Statement will champion the key elements required to unlock industrial success by 2029.

Industrial biotechnology as Europe’s critical strategic technology

Industrial biotechnology uses enzymes, microorganisms and living cells to make biobased products from renewable raw materials and includes fermentation at a commercially competitive scale. This is a key enabler of the EU’s transition from a fossil-based economy to a sustainable bioeconomy, across sectors including chemicals, pharmaceuticals, agri-food, fragrances, detergents, paper and pulp, textiles and bioenergy.

Within this mandate, Europe must deliver the coherent legislative framework through which innovation can flourish and mature, and industry can invest to build long term capacity, adaptability and resilience for Europe’s needs.

It must strengthen existing sector outputs and enable new sector pathways to grow, driven by Europe’s innovation excellence, combining next generation products and transforming manufacturing platforms to stay competitive.

EFIB Brussels Statement – a competitive future for the EU

The 2023 EFIB Rotterdam Statement had three main asks 1) Modernisation of regulation and policy 2) Creating a global perspective and 3) Financing enabling technologies.  In 2024, the EU Commission launched a Biotech and Biomanufacturing Communication including a regulatory simplification study and announced the EU Biotech Act.

The 2025 EFIB Brussels Statement builds on this successful recognition of biotech and looks ahead to the decisions that the EU must now take through the policies and initiatives currently in process. A key opportunity exists for societal and industrial transformation within the sustainability and safety ambitions that make Europe a global figurehead.

Ask 1: Regulation and policy. Aligned and ambitious modernisation for innovation leadership

The legislative cluster, led by the Biotech Act, must reflect coherence on the enablement of biotechnology across elements and a stronger framework for implementation at Member State level.

Europe should strive to achieve simplification and acceleration within existing safety standards to strengthen value chains from R&D to end users and enable the competitive flow and maturation of innovation.

Regulatory pathways should support innovation, yielding with it the competitive advantage conferred through global leadership for breakthrough advances and making the EU an attractive destination for global investment.

Ask: Ensure a streamlined, coherent and predictable legislative environment for industrial biotechnology innovation and biomanufacturing that enables the full strength of the Single Market.

Ask 2: Securing a global position in key supply chains. Capacity for resilience and feedstock

Europe should have the goal to ensure supply chain security within a global context through biotechnology capacity and ecosystems that reflect the skills, employment and logistics required for adaptability and rapid response.

Achieving de-fossilised production at scale through biomanufacturing should be a priority outcome from legislative modernisation with attention towards key strategic supply chains for the EU. It is also crucial to have reliable and cost competitive feedstocks for the success of EU's Bioeconomy

Ask: Europe must identify and strengthen key supply chains through enhanced capacity and skills here and leadership in export and partnership.

Ask 3: Financing innovation. Enabling technologies

The EU should enable and incentivise public and private investment (separately and combined) into the translation of biotechnology innovation into manufacturing at scale.

There should be proactive facilitation of viable business pathways for large scale biomanufacturing, including level playing field across sectors, technologies, Member States and global regions, with incentives and lead market pathways to unlock competitiveness.

Financial frameworks must be matured to reflect the unique requirements and potential of industrial biotechnology, including fermentation and the requirement for consistent and accessible feedstock.

Ask: Ensure speed and scale of finance through public and private pathways for the development and deployment of next generation biotechnology innovation towards EU growth and global performance.

EU Biotechnology legislative cluster 2025-2029