Finnish biotech company Enifer has announced that it has submitted a notified Generally Recognized as Safe (GRAS) dossier to the US Food and Drug Administration (FDA) for its flagship mycoprotein ingredient, PEKILO.
In a statement, the company announced that the decision builds on its self-affirmed GRAS determination from 2025.
This advancement moves PEKILO into formal FDA review, representing a significant step toward establishing large-scale partnerships with US food manufacturers. As demand for functional, high-protein and hybrid food formulations increases, this shift is reshaping ingredient procurement in the American market.
Why this matters
Large manufacturers are increasingly focusing on regulatory clarity and supply chain resilience when adopting new alternative protein ingredients.
The global protein ingredients market is expected to grow from around $75bn in 2022 to more than $125bn by 2031, with the US segment projected to see double-digit growth through the decade.
Additionally, major manufacturers are prioritising clean-label and functional protein formulations to ensure stable and scalable inputs beyond traditional sources.
Elisa Arte, Head of Food R&D at Enifer, said the FDA submission represents an important step in preparing for broader US 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 fibre powder designed for scalable food applications.
PEKILO is a versatile ingredient with up to 50% protein and 35% fiber. According to Enifer, it has an optimal amino acid profile and a neutral taste and colour, making it suitable for various applications, including healthy snacks, dairy and meat alternatives and baked goods.
Its drop-in functionality lets manufacturers achieve high protein and fibre claims without compromising product quality, making PEKILO a reliable choice for regulatory-compliant inputs.
"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 US market.
With regulatory review underway and production scaling in Finland, Enifer says it is expanding its commercial engagement in the United States, targeting food manufacturers seeking stable, high-protein and high-fibre 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.