Finnish Startup Enifer Secures Self-Affirmed GRAS Status for Fungi-Based Protein Ingredient, Paving Way to FDA Review

With the milestone, Enifer’s dry, shelf-stable PEKILO® mycoprotein advances in the FDA regulatory pathway while offering U.S. food manufacturers a clean-label, high-fiber ingredient that is cost-efficient to store, transport, and integrate into production lines.

ESPOO, Finland (September 10, 2025) – Enifer, a Finnish biotech company pioneering sustainable protein ingredients, has achieved self-affirmed GRAS (Generally Recognized as Safe) status for its flagship mycoprotein ingredient, PEKILO®, following an independent expert panel review for use in U.S. food applications. A key step toward FDA-reviewed GRAS status, the milestone opens the door to partnerships with U.S. food manufacturers.

Unlike most mycoproteins, which are sold wet or frozen, PEKILO® comes in a dry, powdered form that ships and stores like flour, making it shelf-stable, cost-efficient to transport, and easy to integrate into production lines for plant-based alternatives, sports nutrition, and healthy snacking at a time when soy remains the dominant but resource-heavy protein source.

“Achieving self-affirmed GRAS status marks a major milestone in the commercialization of our PEKILO® mycoprotein and its entry into the U.S. market. We’re excited to start collaborating with food manufacturers in the US, introducing to the market our ingredient that delivers high levels of digestible protein and dietary fiber, enabling innovation across a broad spectrum of food applications,” said Elisa Arte, Head of Food Research and Development at Enifer.

PEKILO®’s U.S. market debut comes amid surging demand for sustainable proteins. The global market for alternative proteins is expanding roughly 14% annually, while the clean-label category – focused on simple, consumer-trusted ingredients –  is projected to grow at 15.5% per year through 2035.

Enifer is also pursuing notified GRAS status, submitting safety data for FDA review to further strengthen confidence among U.S. food manufacturers.

“Plant-based foods won’t win over consumers unless they’re genuinely better than what came before,” said Simo Ellilä, CEO and co-founder of Enifer. “PEKILO® makes that possible — it brings a neutral color and taste, a natural combination of protein and fiber, and strong water-holding capacity. These properties complement soy and pea proteins, giving food makers new flexibility to develop plant-based products that deliver better texture, nutrition, and overall consumer appeal.”

Founded in 2020, Enifer has developed mycoprotein ingredients for the food and feed industry using a fermentation technology first pioneered in Finland in the 1970s. The process turns food and agricultural industry byproducts into high-quality protein with far lower land use and emissions than animal or soy-based sources.

Enifer’s U.S. expansion builds on €36 million raised in 2024 to scale production, including a commercial-scale mycoprotein facility in Finland. The plant is expected to begin production in 2026 with a capacity of up to 3,000 tonnes a year, and will initially serve customers in the pet food sector, with food-ingredient production to follow soon after.

Enifer will showcase PEKILO® at SupplySide West in Las Vegas this October as it begins partnering with U.S. food manufacturers.

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 byproducts into a high-protein, fungi-based ingredient.

Enifer is scaling production with a commercial-scale facility in Kirkkonummi, Finland, set for completion in 2025, and has recently gained U.S. market access for food-grade PEKILO®. 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.