In its new Bioeconomy Strategy, the EU has outlined its intention to help “advanced fermentation” startups scale up and fast-track their novel food approval pathway.
Amid calls for it to modernise its novel food regulations, the European Union is showing some early signs of promise.
The EU Commission has published a new Bioeconomy Strategy that lays out a 2040 vision featuring a wide deployment of bio-based products, sustainable yield improvements that boost the resilience of food and farming systems, and biorefineries and advanced fermentation facilities that turn diverse feedstocks into food and feed products.
The strategy proposes plans to support fermentation startups with scale-up and regulatory efforts, highlighting technologies that use “innovative, high-performance microorganisms to convert carbon-sources such as sugar residues and other secondary biomass into high-value compounds”.
“The Commission will make technical support available for SMEs scaling innovative bio-based products to accelerate authorisations while maintaining high safety standards,” the strategy states.
“In particular, the Commission will support SMEs developing innovative products based on advanced fermentation, including for food and feed,” it adds.
The move has been welcomed by future food advocates, but only if the EU follows up on these proposals with concrete actions that help fermentation innovators escape the valley of death between lab breakthroughs and commercialisation.
Regulatory sandboxes and novel food approvals in focus
Many proteins derived from advanced fermentation methods, which include biomass and precision fermentation, are subject to the EU’s novel food regulations. This applies to foods that were not commonly consumed in the bloc before 1997, and thus need approval from the European Food Safety Authority (EFSA) to be sold on the market.
The process is fraught with delays and a lack of clarity, and costs up to €250,000, causing significant financial distress for startups, which cannot sell their products and generate revenue until the EFSA completes its authorisation.
The average time it takes for a novel food product to be approved in the EU currently is 30 months, far higher than the stipulated 18-month timeline – and this can stretch to as long as five years. For context, average timelines in Singapore, Australia and New Zealand are 12 to 24 months.
This process presents a huge barrier for future food companies, many of which turn their attention to North America or Asia, where regulatory processes are more streamlined. The Bioeconomy Strategy aims to nip this problem in the bud.
“There is a need to make approvals faster, clearer and simpler,” it states. “The Commission will provide guidance on how to classify new bio-based products and create a single online entry point so that companies only need to submit information once. Risk assessments will be better coordinated across EU agencies to avoid duplication and reduce waiting times.”
It nods to the forthcoming Biotech Acts, the first of which will be published this month, which are set to simplify regulatory requirements, speed up approvals, and introduce regulatory sandboxes. These are controlled environments that let businesses, researchers and regulators design standards and guidance for new products with regulators.
The EU Parliament has recommended the use of sandboxes to assess applications, and is developing a strategy that supports companies transitioning from the sandbox regime to full market access. This is echoed by the Ministry of Future Affairs, a new think tank comprising regulatory experts across Europe, which recently published a framework for a novel food sandbox.
That said, according to Euractiv, an internal document indicates that the EU’s regulatory sandboxes under this month’s Biotech Act would not apply to novel foods.
EU to mobilise investments for fermentation scale-up
In July, a report by companies and organisations including L’Oréal, EIT Food, the Good Food Institute (GFI), and McKinsey suggested that the global advanced biotech sector could create $1T in annual economic value, but would require $500B in investments by 2040 to do so.
Capacity expansion alone would account for 85% of this capital, with the rest needed for regulatory filings, bridging talent gaps, and boosting consumer acceptance. Capacity bottlenecks plague the European sector too, thanks to a lack of large-scale facilities that are often too costly to fund with venture capital, according to GFI Europe.
In a nod to this obstacle, the EU’s Bioeconomy Strategy has proposed to help fermentation startups scale up their businesses and begin commercialising their innovations by expanding access to pilot and demonstration infrastructure.
It will also create a Bioeconomy Investment Deployment Group on finance and investment, combining research, demonstration and scale-up financing across national and EU levels. This brings together the EU Commission, the European Investment Bank Group, national promotional banks, and private investors to create a pipeline of bankable projects, share risk more effectively, and crowd in private capital.
“This coordinated approach should help mobilise public and private investment over the coming decade, particularly for first-of-a-kind biorefineries, advanced fermentation facilities and bio-based materials manufacturing,” the strategy reads.
The EU Commission has previously announced €350M in funding opportunities to boost food and biotech innovation, with fermentation a key focus. Now, it’s introducing blended finance schemes to de-risk investments into the sector. This will help attract more private finance for projects like modern fermentation facilities and first-of-a-kind biorefineries.
“It’s great to see the Commission recognise the crucial role that fermentation can play in driving green growth, reducing our reliance on imports and boosting Europe’s international competitiveness,” said Lea Seyfarth, policy officer at GFI Europe.
“For Europe to establish itself as a global leader in this technology, these proposals now need to be followed up with concrete actions,” she highlighted. “The upcoming Biotech Acts must build on this growing momentum with clear policies enabling startups to commercialise Europe’s scientific expertise and bring innovative food products to the market.”
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