What do we work for?

We accelerate the Green Transition by removing legislative 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 climate change, food shortages, geopolitical uncertainty and excessive land use. 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. 

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 However, legislative barriers and outdated regulation bar them from bringing their solutions to market, lack of financing and scaling opportunities limit their growth and long approval processes hinder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 the Europe and the world. Integrating biosolutions into a new European policy framework and 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 onto the market. And that is what we work for.

  1. Lengthy approval processes in the EU are three times as long as in the US and up to 6-8 years

  2. Various regulatory regimes currently regulate biosolutions, but they are designed to regulate other things

  3. The role of bio-based industries and biosolutions is not recognized and no clear incentives are in place

  4. The European regulatory system is the slowest in the world and does not support reaching our green and competitive targets

Today, biosolutions are regulated by various regulatory regimes in the EU. These sets of rules have one thing in common: they are not designed with biosolutions in mind.

When it comes to sustainable food systems, biodiversity, environment, and especially climate change, the world is at a crossroads; If Europe is to meet its green goals defined in strategies Fit for 55 and Farm to Fork, if the European Green Deal is to fulfil its promise and if Europe addresses globally relevant challenges, e.g., in the context of food and feed scarceness, biosolutions must be an integral part of Europe’s strategy for a sustainable future.

Various regulatory regimes in the EU currently regulate biosolutions, but unfortunately, they are designed with other things in mind. For example, industrial biosolutions are subject to regulations aimed at regulating fossil-based substances and foods, which results in outdated regulatory regiments that do not support innovative biosolutions and the acceleration of the green transition. But the role of bio-based industries and biosolutions are not recognized properly in the legislation.

The lengthy approval process for biosolutions in Europe poses significant challenges. In the EU, it can take up to 6-8 years to get a product approved, three time as long as it does in the US. This prolonged timeline delays the introduction of innovative and potentially life-changing solutions to the market, impeding progress in addressing critical environmental and health issues, stifles the competitiveness of European companies and ultimately slows down our ability to remain as an innovative, green and competitive leader.

If this trend continues, the EU will be remembered as the place where key enabling technologies were born, but grown and scaled elsewhere.

  1. Achieving a sustainable, resilient and competitive Europe

  2. A Europe of the future with bio-based factories and a green economy

  3. Vastly reduced need for fossil materials, water and arable land and an increase in biodiversity

  4. Decreased food waste and produce food for a growing population using a smaller land acreage than today

The potential of biosolutions is so enormous that it is hard to fully understand. They are key to an ambitious vision for a sustainable, resilient and competitive Europe.

We have used biosolutions for longer than history can remember, even to such an extent that they have lost their novelty. Today, through advances in science and biotechnology, a tiny bio revolution with a huge impact is under way. During the last decade progress within research and innovation in biological sciences and technology has created an untapped potential for biosolutions to help Europe and the rest of the world meet some of the biggest challenges of our time.

The vision is to bring Europe back on track to a world where we have vastly reduced our need for fossil materials, water and arable land. A clean environment and a world with enough nutritious food to feed a growing population in a sustainable way. A Europe of the future, where bio-based factories will be offering new jobs and contribute to the growth and resilience of our economy, and at the same time will allow to reduce greenhouse gas emission, achieving the emission goals that the world is setting up as well as derisking susceptible supply chains and reducing import dependencies.

In less than 20 years, the world will require more energy, water and food than we currently produce whilst our planet require us to produce and consume less. Combined with climate change and global crises, it is urgent that we rethink and act on a larger scale.  To do so, we need a circular and biobased economy and paradigm. If we start now, Europe can be a global lighthouse for biosolutions. 

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 futuer 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 ani mportant 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 necesasrily 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 introducting 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 moev 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 centarlized 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. 

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