What do we work for?

We work to boost Europe's resilience and competitiveness while accelerating the green transition by removing legislative and financial barriers to get innovative, sustainable biosolutions from the laboratory to the market in Europe - and beyond.

Europe must speed up

Europe continues to face a myriad of intricate and formidable challenges in the coming years, with issues including geopolitical uncertainty, insecure alliances, lack of food supply security, a great need to boost competitiveness and climate change. And while we have known about these issues for a while, we still hold back a realistic solution: biosolutions. Luckily, Europe already has a diverse range of companies and innovative biosolutions, in everything from food to clothing, that can significantly strengthen us and help alleviate our challenges. But we must speed up, including delivering a bold and broad Biotech Act.

The solution is biosolutions

We already have the know-how and solutions ready to change Europe and the world for the better. However, legislative barriers and outdated regulation bar them from bringing their solutions to market, lack of financing and scaling opportunities limit their growth and long approval processes hinder their potential. They hold life changing and transformative potential for Europe and the world. Integrating biosolutions into a new European policy framework, including the Biotech Act, and new practices will pave the way for sustainability, resilience and competitiveness and shape a better, greener future. It all starts with biosolutions and bringing them from the laboratory to the market.

The window for action has opened: A European Biotech Act. Let’s boost Europe and a greener future with biosolutions and a bold and broad Biotech Act that includes biosolutions.

An opportunity to create lasting change has emerged, but with it follows the need for decisive execution.

It is essential that stakeholders, the Council, the Parliament and the European Commission all work together to deliver meaningful outcomes. As Mrs. von der Leyen rightly proposed in her Political Guidelines, this upcoming period is 'Europe's Choice'. Bringing biosolutions faster to the European market has to be part of that choice. Bringing a bold Biotech Act to Europe has to be part of that choice.

The EU Biotech Act must be ambitious and address current legislative barriers, outdated regulation, lack of financing and scaling opportunities keeping biosolutions from contributing to solving our most urgent problems.

The solutions have been around for millions of years and have already helped shaped Europe and the world what it is today. Biosolutions are the way to solve some of the world's, and Europe's biggest problems. So, let's not wait - let's boost biosolutions now. Watch our movie below.

Our Policy Recommendations

It is clear that we must act. We’ve extensively highlighted the critical reasons as to why biosolutions must be prioritized on the European agenda. There is still so much we must achieve with the ultimate goal of establishing a green and bio-based paradigm.

Consequently, The European Biosolutions Coalition proposes the following policy recommendations that will result in real and lasting change. These are six recommendations for a more horizontal approach to biosolutions, enabling delivery on the EU Green Deal. The horizontal proposals can of course be combined and, if achieved, would mean a new and much faster regime for the future of biosolutions in Europe.

1. Invest in Research, Development and Innovation

For the EU to keep up with other economies and continue to develop new solutions, substantial investments in developing new biosolutions are required. Europe has been ahead until now but is quickly losing ground as other regions and countries ramp up significantly.

Biosolutions should be part of the future Horizon program. In addition, biosolutions aimed directly at the agricultural sector should be integrated in the revision of the common Agricultural Policy (CAP).

2. Improve incentives to invest in scaling and infrastructure capacity

To accelerate getting biosolutions to market, investment incentives must be improved. SME's have particular difficulties financing infrastructure to scale their biosolutions, especially through the early phase of the "valley of death".

Therefore, Pilot Facilities are needed to enable transition from R&D to market. We call on member states to explore possibilities to utilise IPCEI funds for bio-reactors. The development of a model where the EU could be co-investor in public-private partnerships, in infrastructure for scaling, could be a way forward for example through the European Investment Bank (EIB) and the European Innovation Council (EIC). Today there is a massive lack of investments in late stage-ventures for upscaling of biosolutions companies, also due to the regulatory barriers.

3. Ensure Fair EU Classification and revise the NACE codes

A new EU industrial policy is here to stay. It is therefore essential that biosolutions, biotechnology and biomanufacturing are placed at the heart and centre of the industrial policy, as well as reflected in the legislative proposals that follow from the new industrial policy program.

To achieve this, biosolutions should be recognized in the EU classification of economic activity, the so-called NACE codes. Bio-based chemistry provides an important contribution to sustainability and defossilisation with raw materials leading to lower greenhouse gas emissions and the offer of bio-degradable or bio-compostable products.

We are fully aware that biosolutions are not the only solutions to promote sustainability, and the use of bio-based raw materials is not necessarily the most sustainable solution every time. But to ensure that biosolutions investments are accurately classified as sustainable when appropriate, in addition to further increase access to sustainable finance for biosolutions companies, biosolutions should be included in the EU taxonomy and biosolutions should be integrated next time there is an update of the NACE codes.

Well ahead of time, the biosolutions sector hope to be involved in the discussion on exactly how this could be done.

4. Develop and use a Risk-Benefit Approach

Biosolutions suffer from a disproportionate focus on environmental and human health risks, compared to the environmental and human health benefits of the solutions. In addition, environmental externalities are not priced in most traditional products. Also, bio-based products do not receive proportionate benefits for doing relatively lesser harm to the environment and human health.

We suggest introducing and, to a much higher degree, use a risk-benefit analysis framework. This approach will guide regulatory decisions by considering and weighing both potential benefits and disadvantages. In this regard it will help if the EU Innovation Principle is fully implemented in all EU regulation and policy.

5. Develop a European model of market access for biosolutions

The model could be a GRAS-inspired approach. GRAS is an American paradigm, which stands for Generally Recognised As Safe, where companies must apply due diligence in demonstrating and getting expert consensus on the safety of new biological solutions.

This is a clear and straight forward process that secures the safety of products while avoiding the lengthy and administratively demanding approval processes currently in place in the EU. A similar model could be very helpful for example in the future revision of the REACH directive.

6. Develop a framework for the fast approval of sustainable biosolutions

To accelerate the green transition, there is a need to allow for faster approval of sustainable biosolutions within several areas. These products are currently regulated under different regimes, which are cumbersome and time consuming. These regimes do not consider the risk profiles of products based on biosolutions and do not consider their ability to facilitate our green ambitions. A new horizontal framework, inspired by the EU's existing "New Legislative Framework" for products, could make up for that.

Approval procedures should move away from a process centric to a product centric approach. It should build on a risk-benefit approach and ensure regulatory sandboxes, allowing for the development, testing and validation of innovative technologies in a controlled real-world environment, the full implementation of the Innovation Principle. Furthermore, it should provide better conditions for applicants to develop higher quality applications. Also, an approach to solve the challenges related to capacity shortages for assessment should be part of this framework.

To facilitate the shift towards a green and bio-based economy, a centralized approval process for biosolutions (i.e., living organisms: plants, animals and microorganisms could be established at a European level, including a mechanism ensuring coordination across units and member states. This new framework will allow for streamlining and speeding up the registration and approval process.