Enifer 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 soy 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 meat and dairy alternatives, baked goods, breakfast cereals, biscuits, and crackers. 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.