Finnish biotech innovator Enifer has taken a significant step toward expanding its footprint in the United States, submitting a notified GRAS (Generally Recognized as Safe) dossier to the US Food and Drug Administration for its flagship mycoprotein ingredient, Pekilo.
The move transitions the ingredient from a 2025 self-affirmed GRAS determination into formal FDA review, positioning the company for deeper engagement with US food and beverage manufacturers.
The filing comes at a pivotal moment for the alternative protein sector. After years of rapid innovation, large-scale manufacturers are increasingly prioritising regulatory certainty and supply chain reliability when evaluating new ingredients.
This shift reflects broader industry pressures around compliance, reformulation and the need for scalable, cost-effective inputs.
Elisa Arte, head of food R&D at Enifer, said: “Eliminating regulatory uncertainty is critical to advancing commercial conversations. FDA-notified GRAS status allows discussions to move beyond technical validation into long-term supply planning. At the same time, scaling production ensures we can meet industrial demand with consistent volumes.”
Pekilo is produced via a proprietary fermentation process originally developed in Finland, which converts food and agricultural side streams into a dry, shelf-stable protein and fibre powder.
The ingredient contains up to 50% protein and 35% fibre, with a neutral taste and colour profile that enables use across a wide range of applications, from snacks and baked goods to dairy and meat alternatives, including hybrid formulations.
Its “drop-in” functionality is particularly attractive for manufacturers seeking to enhance protein and fibre content without compromising sensory characteristics, an ongoing challenge in product reformulation.
Simo Ellilä, CEO and co-founder of Enifer, said: “Demand for protein remains strong, but sourcing strategies are evolving. With regulatory review underway and our 2026 production ramp-up approaching, we are aligning capacity and compliance to support structured, long-term supply relationships in the US.”
The company is currently scaling production at its commercial facility in Kirkkonummi, Finland, scheduled for completion in 2026. Parallel to its US regulatory efforts, Enifer is pursuing novel food approvals in multiple international markets, including the EU, UK and Singapore.
As FDA review progresses through 2026, Enifer is intensifying engagement with US manufacturers across several categories, targeting partners seeking stable, high-protein, high-fibre ingredients that integrate seamlessly into existing production systems.
