Europe’s position as a leader in biotechnology and food innovation is under threat due to regulatory barriers and inefficiencies that delay the access of complementary proteins to the EU market. This harms European competitiveness, strategic autonomy, and food security.

Europe already depends on the US for the commercialisation of European innovations and on China for the supply of rare earths and other critical materials. Additionally, the EU is also increasingly dependent on food-and-feed inputs produced by biomanufacturing in China. Food-and-feed biotechnology is not science fiction – it is already a reality for Europe. Consequently, Europe is exposed to significant supply-chain dependencies which threaten the independence and security of our democracies.

Although the EU’s novel-food pre-market approval is competitive in terms of its regulated timeline and robustness, in practice the timeline is often more than twice the regulated length, making the approval process highly costly by international standards. This, along with the absence of basic favourable regulatory conditions for European startups in general, hinders investment in the EU and the commercialisation of European food innovation in its home market.

Instead, an ever-increasing number of European startups are leaving the EU at an increasingly early stage, after initially finding favourable conditions for setting up in Europe. The European food-and-biotech innovation ecosystem lacks an environment that supports innovation, while international investors and other countries and regions benefit from emerging foods and related manufacturing technologies invented in Europe that are then exported.

As Mario Draghi reminded us a year after his landmark report on the state of European competitiveness:

Despite Draghi’s clear diagnosis on a general level and the path set out by the Commission’s agenda, we do not see enough decisive and coordinated action taken to support emerging foods derived from food biotechnology as a strategic technology, starting with a competitive regulatory approval process.

In order to strengthen European competitiveness, help biotech food companies to scale at home, and avoid further widening the innovation gap between breakthrough food science and regulation, this briefing proposes a framework for a pan-European regulatory sandbox for complementary proteins, such as novel foods. The framework is intended for use by those Member States that wish to accelerate safe, science-based regulatory efficiency in order to support food innovators, while maintaining high food-safety standards. Based on an analysis of regulatory key pain points from a user perspective, the authors of this brief propose a framework that responds to Draghi’s criticisms and can help to achieve the goals of the national sandbox efforts through pan-European collaboration, rather than continuing with fragmented and inefficient national efforts.

The main objective of the proposed framework is to improve efficiency by improving dossier quality, while also creating transparency for applicants in terms of data requirements and timelines. The framework aims to limit approval timelines to the regulated 18-month period, develop best practices, and reduce the fragmentation of sandbox approaches across Member States, thereby ensuring that European companies can choose Europe first and scale within the EU. Ultimately, the framework aims to transform regulation from a barrier into a strategic enabler, thus ensuring Europe’s food and economic security and its technological leadership. It provides a streamlined regulatory sandbox approach for novel foods for European Member States who want to champion and benefit from biotechnology and the biomanufacturing of innovative foods.

The Competitiveness Compass,³ which guides the work of the European Commission for the period 2024–2029, is based on the landmark report on the Future of European Competitiveness by Mario Draghi.⁴ The plan for Europe to regain its economic power and prosperity is built around three strategic pillars:

Despite these ambitious aims, Europe’s regulatory efficiency is falling behind breakthrough science in deep tech, such as in the areas of biotechnology and the biomanufacturing of emerging foods. This is already significantly harming European competitiveness and will do so for generations to come, while also exposing the European Union to new geopolitical risks, particularly with regards to food-and-feed security. In order to close the innovation gap and reduce external dependencies, Europe’s world-class biotech and food-manufacturing startups, as well as its global food manufacturers and manufacturing-technology companies, need to be able to scale biomanufacturing and commercialise in Europe first, thus allowing them to complement the existing food supply provided by Europe’s rich cultural heritage.

Extra-EU dependencies in our food-and-feed supply need to be reduced by bringing the production of critical inputs back to Europe and diversifying supply. As a net-zero technology, food biomanufacturing could generate around $400 billion for food-related biotech markets by 2040.⁵ This would enhance the EU’s competitiveness, food autonomy, and sovereignty, while strengthening European security and preparedness.

Enabling a coordinated and collaborative approach to a regulatory sandbox for novel food for Member States willing to collaborate would contribute to a safe and more efficient pre-market approval process.

Approving emerging foods more efficiently is essential if Europe is to scale up, close the innovation gap, and reduce its external geopolitical dependencies.

However, while the strategic importance of an efficient regulatory pathway is widely recognised in the context of medical biotechnology, this is not yet the case for food biotechnology, including the support of those emerging foods in defence or dual-use contexts, in the EU.

Against this background, the purpose of this strategic brief is to provide a solution-oriented approach to building an innovation-friendly regulatory pathway for emerging foods.

These new foods and their manufacturing technologies are a means to an end, contributing, alongside other food sources, to securing Europe’s strategic autonomy, decarbonisation, and food and economic security.

While the authors of this brief fully support the EU’s high food-safety standards, we also believe in our capability as Europeans to make our regulatory systems and the regulatory approval process work within the regulated timeline, thereby ensuring that the EU does not further slip into extra-EU dependencies for our food-and-feed production.

In this sense, this brief should be understood as a contribution to the objectives set out for the mandate based on Mario Draghi’s findings. Europe should not see its own food innovation as antagonistic to its traditional food heritage but as essential to strategic autonomy and sovereignty, especially at a time when China is striving to maximise its geopolitical influence and technological dominance and is investing heavily in food-and-feed biomanufacturing.

As a leader in biotechnology, China will be able to exert the same kind of control over food and feed derived from biomanufacturing that it currently does over rare earths and critical materials, thereby undermining European food and economic security.

The true cost of regulatory barriers is a further loss of competitiveness and strategic autonomy, as investment in Europe is deterred.

Investor confidence in the European Union’s novel-foods authorisation process – particularly its time-to-market and predictability – has significantly eroded. As a result, EU-based food-tech investors recommend that companies launch in the United States. However, to safeguard the security and quality of our food supply and uphold Europe’s high standards, European companies need to have reliable and effective access to the Single Market.

Regulatory uncertainty, amplified by the absence of a unified market for capital, has led to the EU being deprioritised as an investment destination and undermined the attractiveness of the Single Market. Consequently, European capital that would otherwise have been invested in the EU is ultimately diverted instead to the US and Asian markets, further strengthening the technological leadership and competitiveness of the US and China.

The regulation of novel foods is not an end in itself – it is a means to securing Europe’s food sovereignty and food security. Europe is facing a choice: enable and control food biomanufacturing at home or get controlled by it from abroad.

Europe’s livestock sector already depends on China for critical feed inputs such as essential amino acids and vitamins. Industry data indicates that most of these inputs are imported from China, exposing a key structural vulnerability in our food system and weakening Europe’s sovereignty.

A recent report from the European Feed Manufacturers Federation highlighted the fact that China produces, by volume, between 65% and 90% of precision-fermentation-derived amino acids and between 50% and 100% of the vitamins currently imported into the EU for animal consumption.⁶

Moreover, China is investing heavily in food biomanufacturing due to its strategic significance. This is evidenced by the number of generally recognized as safe (GRAS) notifications made to the United States Food and Drug Administration (FDA) by Chinese companies. Recently, 49% of the GRAS notices on the first page of the inventory were submitted by Chinese companies, all for innovative ingredients derived from fermentation or precision fermentation.⁷ China is clearly aware that gaining a competitive advantage in terms of food security through food biomanufacturing, as part of a broader agricultural-processing and food-manufacturing strategy with biotechnology as a key component, will further consolidate the country’s position of leadership at the intersection of geopolitics and technology.⁸

In addition to the United Kingdom, which is well advanced with its cell-cultivated-product regulatory sandbox and has just launched a regulatory innovation research programme for precision fermentation, several EU Member States, including Denmark, Spain, the Netherlands, and Germany, are exploring or preparing various experimentation spaces for novel foods.¹⁰ The majority of the cell-cultivated regulatory sandbox participants in the UK are novel-food companies located in the EU. To date, only two of the participating companies have submitted novel-food applications in the EU.

As the example from the UK shows, countries that develop optimised regulatory processes and support experimentation spaces such as regulatory sandboxes can be expected to attract innovators and investors, thereby benefiting in terms of both competitiveness and access to strategic technologies.

In the global biotech race, Europe needs to act more in line with the objectives set out in the Competitiveness Compass and transform the novel-food regulation from a barrier into a strategic enabler of biotech leadership, thereby avoiding further loss of competitiveness and autonomy and preventing Europe from slipping into greater dependency on China and the US.

In recent years, the polarisation around the term ‘alternative proteins’ has had a negative impact on the novel-food sector. According to our research, the term ‘alternative protein’ has its roots in earlier usage in animal-nutrition literature.¹¹ It is imperative that the EU does not become further embroiled in a proxy war over ‘alternative proteins’ and ‘non-natural foods’, which pits the farming community against new foods. This is counterproductive and undermines Europe’s preparedness, competitiveness, and security.

It is hoped that this briefing will contribute to the de-polarisation of emerging foods and return to a discussion in which the geopolitical and technological importance of food biomanufacturing as a provider of complementary proteins is recognised through regulatory efficiency.

Europe cannot afford further polarisation that discredits its own scientific achievements in strategic biotechnologies. Many biomanufacturing technologies for emerging foods have been developed in Europe and received early-stage funding from the EU, only to be scaled up and commercialised outside Europe due to the significant time it takes to bring them to market, compared to other global markets.

It is vital that we close the European innovation gap by establishing optimised regulatory pathways for strategic technologies, including food biomanufacturing and biotechnology.

In recent years, regulatory sandboxes have attracted considerable attention as a means of exploring more flexible approaches to governing emerging technologies. However, much of the debate has focused on the limitations of policy and regulatory innovation, rather than on potential solutions. This might also explain why several Member States have adopted individual sandbox approaches, with widely varying ambitions and levels of depth.

In order to design a regulatory sandbox that is in line with harmonised EU food law, it’s crucial that Member States recognise the importance of regulatory sandboxes and adopt a coordinated approach to unlocking their potential through a joint regulatory learning process. The purpose of this strategic brief is to inspire an efficient and collaborative pan-European approach to a novel-foods sandbox.