Enifer moves PEKILO® mycoprotein into FDA review, positioning for large-scale U.S. food partnerships

Following its 2025 self-affirmed GRAS determination, the Finnish biotech company seeks FDA “no questions” status for its fermentation-derived, shelf-stable protein ingredient designed for industrial food applications.

ESPOO, Finland (24th of March, 2026) -– Enifer, a Finnish biotech company pioneering sustainable protein ingredients, has submitted a notified GRAS (Generally Recognized as Safe) dossier to the U.S. Food and Drug Administration for its flagship mycoprotein ingredient, PEKILO®. The filing builds on the company’s 2025 self-affirmed GRAS determination and moves PEKILO® into formal FDA review, marking a significant step toward large-scale partnerships with U.S. food manufacturers as demand for functional, high-protein, and hybrid food formulations reshapes ingredient procurement in the American market.

Following a period of rapid innovation in alternative proteins, large manufacturers are increasingly prioritizing regulatory clarity and supply chain resilience as adoption criteria for new ingredients, consistent with broader shifts in industry compliance and reformulation pressures. The global protein ingredients market is projected to grow from roughly $75 billion in 2022 to more than $125 billion by 2031, while the U.S. alternative protein ingredients segment alone is expected to grow at double-digit rates through the end of the decade. At the same time, clean-label and functional protein formulations are becoming procurement priorities for major manufacturers seeking stable, scalable inputs beyond traditional plant-based and animal sources. 

Elisa Arte, Head of Food R&D at Enifer, said the FDA submission represents an important step in preparing for broader U.S. commercial partnerships: “Large food manufacturers operate within strict procurement and compliance frameworks. FDA-notified GRAS status removes a key internal barrier, allowing ingredient discussions to move beyond technical sampling into long-term supply planning. At the same time, we are scaling production to ensure consistent, industrial volumes. In a market that has moved past hype and is now focused on unit economics and reliable capacity, regulatory clarity and manufacturing readiness must advance together. This step brings PEKILO® into that commercial decision framework.”

Enifer develops mycoprotein ingredients using a proprietary fermentation technology originally pioneered in Finland. The company converts food and agricultural industry side streams into PEKILO®, a dry, shelf-stable protein and fiber powder designed for scalable food applications. PEKILO® contains up to 50% protein and 35% fiber, with an optimal amino acid profile and neutral taste and color that allows it to be used across a wide range of applications, including healthy snacking, dairy and meat alternatives and hybrids, and ready-to-eat snacks and baked goods. Its drop-in functionality helps manufacturers achieve high-protein and high-fiber claims without affecting product sensory profiles, positioning PEKILO® as an industrially viable input for manufacturers seeking stable, regulatory-ready ingredients.

“Demand for protein isn’t slowing, but manufacturers are rethinking where that protein comes from and how it performs in finished products,” said Simo Ellilä, CEO and co-founder of Enifer.  “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 U.S. market.”

With regulatory review underway and production scaling in Finland, Enifer is expanding its commercial engagement in the United States, targeting food manufacturers seeking stable, high-protein, and high-fiber ingredients that integrate into existing production systems. The company expects the FDA review process to continue throughout 2026 as it advances discussions across multiple food categories.

About Enifer 

Enifer is a Finnish biotech company founded in 2020 as a spin-off from VTT Technical Research Centre of Finland to commercialize the proprietary PEKILO® mycoprotein technology. Originally developed and used at industrial scale by the Finnish forest industry in the 1970s, the process converts food and agricultural industry side streams into a highly nutritious, fungi-based ingredient. 

To date, Enifer has raised almost €60M, and is scaling production with a commercial-scale facility in Kirkkonummi, Finland, set for completion in 2026. Enifer has recently gained U.S. market access for food-grade PEKILO®. Enifer has also applied for novel food approval in the EU, UK, and Singapore. The company has validated its ingredients with global partners, including Skretting (the aquafeed division of Nutreco), Purina (pet food), and Valio (consumer foods). 

For more information, visit www.enifer.com.