Finnish biotech company Enifer has obtained self-affirmed GRAS (Generally Recognized as Safe) status in the US for its mycoprotein ingredient Pekilo, following an independent expert panel review.

The step paves the way for partnerships with US food manufacturers, with FDA-reviewed GRAS status still to be pursued.

According to the company, Pekilo differs from most mycoproteins by being supplied in dry, powdered form, making it shelf-stable, easier to transport and simpler to integrate into production lines. It is targeted at plant-based alternatives, sports nutrition and healthy snacks as a lower-impact alternative to soy.

“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 colour 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 uses fermentation technology first developed in Finland in the 1970s to convert food and agricultural byproducts into protein with lower land use and emissions than animal or soy-based sources.

The US entry follows Enifer’s €36 million raise in 2024 to build a commercial-scale mycoprotein facility in Finland, due to start production in 2026 with a 3,000-tonne annual capacity. The plant will initially supply the pet food sector, with food-ingredient production to follow.

Elisa Arte, head of food research and development at Enifer, added: “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 fiber, enabling innovation across a broad spectrum of food applications."

Enifer will present Pekilo at SupplySide West in Las Vegas this October as it begins US market outreach.