Enifer's fungi protein secures self-affirmed GRAS status

Published: 11-Sep-2025

The milestone paves the way to FDA review for the Finnish startup's clean-label, high-fibre mycoprotein

Enifer has achieved self-affirmed GRAS (Generally Recognised as Safe) status for its flagship mycoprotein ingredient, PEKILO, following an independent expert panel review for use in US food applications.

The milestone opens the door to partnerships with US food manufacturers and marks a key step toward FDA-reviewed GRAS status. 

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.

This comes at a time when soy remains the dominant but resource-intensive protein source and other mycoproteins are being sold in wet or frozen forms.

Elisa Arte, Head of Food Research and Development at Enifer, said: “Achieving self-affirmed GRAS status marks a major milestone in the commercialisation of our PEKILO mycoprotein and its entry into the US 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 fibre, enabling innovation across a broad spectrum of food applications."

Enifer's fungi protein secures self-affirmed GRAS status

PEKILO's debut in the US market comes amid surging demand for sustainable proteins.

The global market for alternative proteins is expanding roughly 14% annually, whilst the clean-label category 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 amongst US food manufacturers.

“Plant-based foods won’t win over consumers unless they’re genuinely better than what came before,” said Simo Ellilä, CEO and founder of Enifer.

“PEKILO makes that possible — it brings a neutral colour and taste, a natural combination of protein and fibre 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.”

Enifer's fungi protein secures self-affirmed GRAS statusEnifer's mycoprotein fermentation technology, first pioneered in Finland in the 1970s, turns food and agricultural industry byproducts into high-quality protein with far lower land use and emissions compared with animal or soy-based sources.

The company's US expansion builds on €36m 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 3000 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 US food manufacturers.

You may also like