What do we work for?

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).

To accelerate getting biosolutions to market, investment incentives must be improved. SME's have particular difficulties financing ifnrastructure 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. 

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.

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. 

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.

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.