EU Biotech Act: Approval pathways for precision fermentation eased despite restrictions on novel foods

The European Commission’s Biotech Act, published this week, will expand the regulatory guidance available to companies bringing precision fermentation ingredients to market, but has excluded novel foods from a parallel scheme designed to foster collaboration between regulators, industry, and academics — a decision nonprofit think tank GFI Europe says undermines efforts to build expertise and transparency around emerging food technologies. 

The Act focuses primarily on health sector competitiveness but includes measures affecting food companies using biotechnology techniques, such as precision fermentation, to produce ingredients ranging from animal-free dairy proteins to sustainable palm oil alternatives. 

The legislation strengthens the pre-submission advice function at the European Food Safety Authority (EFSA) while simultaneously barring novel foods from accessing regulatory sandboxes — frameworks that allow regulators to work directly with companies and researchers to develop appropriate standards for new technologies — on grounds they may “trigger ethical or cultural concerns among various consumer segments.”

GFI Europe argues this creates a contradiction: excluding the technology from a mechanism specifically designed to address knowledge gaps and build stakeholder confidence through open dialogue.

EFSA guidance expansion 

Companies applying to sell precision fermentation ingredients in the EU must submit applications to EFSA, which conducts safety and nutritional assessments before products can be sold across all 27 member states. 

The Biotech Act proposes expanding the EFSA’s capacity to provide technical and scientific guidance to applicants before formal submissions, including additional staffing.

“The EU has one of the world’s most robust food safety regulatory systems, which is crucial for ensuring people have confidence in new products,” Seth Roberts, senior policy manager at GFI Europe, tells Food Ingredients First. “However, European startups have faced lengthy authorization delays, in part because they lack the clarity needed about the type of details required — sometimes providing too little or the wrong kind of data.”

The EU's novel food authorization process has faced criticism for lengthy delays that push startups toward faster markets.Roberts says expanding pre-submission guidance should help address these bottlenecks by giving producers clearer information about data requirements for their application dossiers.

The measure targets a specific challenge in the EU’s novel food authorization process: applicants have struggled with uncertainty about evidentiary standards, leading to incomplete submissions and extended review timelines, even though the regulatory system itself is rigorous and science-based.

The authorization challenge has become a flashpoint across the industry, with experts at the Future of Protein Production conference in Amsterdam last month debating how European companies increasingly pivot to faster markets like Singapore while awaiting EU decisions.

Novel foods exclusion 

The commission proposes establishing regulatory sandbox frameworks for various biotechnology applications but has specifically excluded novel foods from eligibility.

“Sandboxes provide important opportunities to share expertise between business, academics, and regulators, boosting knowledge and enabling staff to make better-informed decisions,” Roberts explains. “The decision to exclude novel foods from the scheme is disappointing and a wasted opportunity for driving forward evidence-based regulation.”

GFI Europe has called for sandboxes to be introduced across all regulatory food and feed categories so the full range of production technologies can benefit from collaborative standard-setting processes.

The exclusion is particularly counterproductive given the commission’s stated rationale, Roberts argues. “Sandboxes are ideally placed to explore consumer views and build confidence in new technologies in a transparent manner by providing opportunities for open dialogue between producers, regulators, and consumers,” he says. 

“Refusing to enable sandboxes for novel foods does nothing to help address these considerations, and only serves to keep information about new products and the regulatory path to market opaque for consumers.”

Consumer research and market readiness

Research conducted by GFI Europe with Accenture found that around half of consumers in France, Germany, and Spain are willing to try dairy and egg products made using precision fermentation if given a free sample or if someone else prepared it for them, with around one in five saying they would add these products to their diet.Precision fermentation produces ingredients like animal-free dairy proteins and sustainable palm oil alternatives.

The EIT Food Consumer Observatory found 43% of respondents across France, Spain, Italy, Greece, Poland, and Denmark would be willing to try dairy products produced using precision fermentation, while 2024 research by the HealthFerm project showed 52% of consumers across nine European countries were willing to try precision fermentation products.

Precision fermentation has been used for decades to produce ingredients such as rennet for cheesemaking. Its application to develop proteins and fats that can deliver the taste and texture of animal products in plant-based foods is more recent, though it builds on established manufacturing principles.

Infrastructure gap remains unaddressed

The Biotech Act addresses regulatory clarity but doesn’t resolve what industry stakeholders identify as the primary commercialization bottleneck: a lack of large-scale fermentation manufacturing capacity in Europe, Roberts argues. 

“One of the biggest bottlenecks the industry faces is a lack of infrastructure — right now, the large-scale fermentation facilities needed to really ramp up production don’t exist,” he says. “We urgently need to see investment from the EU, national governments, and the food industry to deliver the capacity necessary to make these options accessible to everyone.”

The act proposes establishing a pilot investment facility to support the scale-up of health biotechnology. GFI Europe has called on the commission to include ambitious financing for food biotechnologies in a planned second Biotech Act expected in late 2026.

The organization has previously published research on blended finance models that could help address the infrastructure gap, arguing that coordinated investment from public and private sources will be necessary to build the manufacturing ecosystem needed for commercial-scale production.

Roberts describes the current act as playing “an important role in bringing new products to market in a way that meets the EU’s world-beating safety standards, helping to drive green growth, reduce our reliance on imports and boost competitiveness.”

However, he notes that the sandbox exclusion represents a “missed opportunity to drive forward evidence-based regulation while providing a forum for open dialogue that can give consumers more confidence in new products.”