PPTI Web Exclusive: From heritage to horizon – Enifer’s Pekilo mycoprotein takes bold step in the USA

Finnish biotech Enifer has secured self-affirmed GRAS status for its Pekilo mycoprotein, clearing the way for early US entry. CEO Simo Ellilä explains how the shelf-stable format sets it apart and why taste and price remain the ultimate test for alternative proteins

Finnish biotech startup Enifer has reached a pivotal milestone in its push to bring fungi-based proteins to the global food system. The company has secured self-affirmed GRAS (Generally Recognized as Safe) status for its flagship ingredient, Pekilo, paving the way for early partnerships with US food manufacturers and setting the stage for FDA-reviewed GRAS status.

“Achieving self-affirmed GRAS status marks a major milestone in the commercialization of our Pekilo mycoprotein and its entry into the US market,” says Elisa Arte, Head of Food Research & Development at Enifer. “We’re excited to start collaborating with food manufacturers in the USA, 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.”

Unlike most mycoproteins, which are typically sold wet or frozen, Pekilo is dry, flour-like, and shelf-stable. For Enifer, that distinction is not only about convenience and cost efficiency – it is about unlocking applications across categories from plant-based meat to dairy alternatives, sports nutrition, and snacks.

A bold step with self-affirmation

For Simo Ellilä, CEO & Co-founder of Enifer, the decision to pursue self-affirmation before full FDA review was carefully considered. “The way we approached regulatory approval for our food-grade ingredient was to compile a comprehensive set of data demonstrating its safety,” he explains. “We’ve pursued approval in Europe, Singapore, the UK, and the USA, and after careful discussions, we decided it made sense to take this first step with self-affirmation.”

The move allows Enifer to test the waters with pioneering US partners while building toward the coveted ‘no questions’ letter from the FDA. Ellilä notes that companies such as The Better Meat Co. and Meati have sold significant volumes under self-affirmed GRAS, proving the pathway viable.

“For us, it’s only one step on the path toward full FDA approval,” he says. “But self-affirmation allows us to begin early market entry – probing the market and testing with pioneering partners.”

“Self-affirmation allows us to begin early market entry – probing the market and testing with pioneering partners”

Clearing up misconceptions

From his vantage point as a European founder, Ellilä sees lingering misunderstandings about US regulation.

“I think there’s a misconception in Europe that in the USA things are somehow easier or more lax,” he says. “But really, it’s just a different process. The safety data we have is the same across all jurisdictions, and it clearly demonstrates the safety of our product.”

For food manufacturers, however, risk appetite varies. “For initial market entry, self-affirmation works fine,” Ellilä says. “But in our case, as a B2B company aiming to supply large CPG groups in the future, that ‘no questions’ letter from the FDA is something we'd probably need in the long term.”

Pekilo’s flour-like format is a rarity in the mycoprotein space, and one of Enifer’s strongest differentiators.

“For those not familiar with Enifer, our technology is based on an old concept that has long existed in the feed manufacturing space. That’s really our DNA – the focus on production efficiency and a shelf-stable product. We've built on that fundamental approach to create a novel food-grade ingredient,” says Ellilä. “After lengthy discussions with food companies, we realized there was a clear niche for a product like ours. Nobody else was doing it, and we had an attractive proposition in terms of both product and price point that many found compelling.”

Shelf stability means Pekilo ships and stores like flour, sidestepping the logistical headaches of chilled or frozen alternatives. That, in turn, opens the door to more mainstream food manufacturers who value ingredients that fit seamlessly into existing processes.

Surprising applications

What began as an alternative protein for plant-based meat quickly revealed itself to be far more versatile. “When we first entered the food space, we honestly had no idea what to expect. I had a very simplistic view that we’d just be replacing pea protein one-to-one,” Ellilä admits. “It never even crossed my mind that we could go into dairy.”

That changed when Valio, Finland’s dairy giant and an Enifer shareholder, began experimenting with Pekilo. “They’ve done amazing work with yogurt-type and smoothie-type products, which I never imagined would be possible,” he says. “Initially I was focused on alt-meat applications, but it’s been great to see just how versatile Pekilo really is. Maybe my favorite so far has to be breakfast cereal – the best I’ve ever had was a simple combination of rice with Pekilo.”

For many formulators, the unspoken challenge with alternative proteins is taste. Off-flavors and gritty textures from soy or pea protein often require masking, adding cost and complexity.

“One of the nicest surprises was realizing that our product isn’t just neutral in taste and color – it actually improves blends,” Ellilä says. “When combined with plant-based proteins, Pekilo helps create an overall more neutral product. That’s going to add real value for food manufacturers, because it allows them to avoid many of the off-flavors typically associated with legume-based proteins.”

Taste and price before all else

The alternative protein sector often leans heavily on its sustainability credentials. But Ellilä argues that consumer adoption is still driven by more immediate considerations.

“When you really boil it down, the first priorities for consumers – especially in today’s market after inflation concerns – are taste and price,” he says. “Those are the first things people care about. Environmental sustainability and other considerations come after that. At the end of the day, when you’re in the store making a purchase, you’re thinking, do I like this product, and what does it cost?”

This pragmatic view shapes how Enifer talks about Pekilo to potential partners. Environmental benefits may win headlines, but taste and affordability win repeat purchases.

Complementing soy, not replacing it

Soy remains the dominant plant protein worldwide, and Pekilo is not designed to supplant it entirely. “What we’ve learned is that Pekilo is really an ingredient in its own right,” Ellilä says. “It has features that legume-based proteins don’t have – and vice versa. What we see time and again is that they actually work better together. So rather than replacing 100% of soy or pea, replacing about 50% with our mycoprotein often leads to a better overall product.”

Enifer’s story is unusual in that it builds on a 1970s Finnish innovation originally developed for the paper industry. The company has embraced that history as part of its brand identity, while highlighting the futuristic applications now possible.

“It brings a lot of credibility – knowing the technology works and that scale-up is proven,” Ellilä says. “But the novelty comes from the applications and use cases. Using mycoprotein in the way we do, especially for food, is something completely new. That’s where the futuristic element comes in.”

“One of the nicest surprises was realizing that our product isn’t just neutral in taste and color – it actually improves blends”

Sustainability as carbon recycling

A defining part of Enifer’s narrative is its ability to turn byproducts into high-quality protein. But Ellilä is careful not to let that be framed as a compromise.

“We try to focus on the fact that what we’re really doing is recycling carbon. That’s at the core of our approach,” he says. “In the food-grade space, we only use food-grade inputs, so the product is never compromised – in fact, I’d argue it’s better because of the approach we take.”

Looking ahead, Ellilä believes sustainability conversations will widen beyond carbon. “Up to now, everyone has been so focused on CO2 – it’s become like a second bottom line,” he says. “But I think we’re going to see growing awareness of other impacts, like biodiversity and eutrophication. Here in Finland, for example, eutrophication is a major concern because our Baltic Sea suffers from huge algal blooms caused by nutrient runoff from agriculture.”

Enifer’s first commercial-scale facility, due to open in Finland in 2026, will initially serve the pet food sector before expanding into food ingredients.

“The consumer drivers are actually quite similar – and often it’s even the same consumer,” Ellilä says. “Understanding what makes them choose a product with our mycoprotein, whether it’s for their pets or eventually for themselves, is key. If we can get those core messages across, I think it will serve us very well as we move from pet food into human food.”

To date, Enifer has raised around €50 million (equity, grants, and loans combined) to support its expansion. Much of that capital has come from Finnish backers.

“Because of our unique heritage, building on a proven Finnish innovation, our story has been easiest to sell domestically,” Ellilä says. “That’s why our cap table is heavily skewed toward Finnish investors. More broadly, in the food and agtech space, non-specialist investors have largely left the room. So, it’s really about engaging with people who understand the sector and convincing them why your technology is the one worth backing.”

Looking to the USA and beyond

Scaling is Enifer’s immediate priority. “The facility we’re building in Finland is the first step, and we already have several plans in place for what our rollout strategy could look like,” Ellilä says. “If we gain strong traction in the US food market, then local production there is definitely something we’ll be looking at.”

Even amid uncertainty in financial markets, he is confident the company is on a solid footing. “Looking back at where we’ve come from, what keeps me up more at night are geopolitical shifts and how they impact financial markets – and, to some extent, consumer behavior – rather than concerns about our technology,” he says.

Ultimately, Ellilä’s ambitions for Pekilo go beyond regulatory milestones and factory openings. He wants the ingredient to reset consumer expectations about what plant-based foods can be.

“What I’d really hope is that it changes people’s approach to plant-based and flexitarian diets, just as it has for me when I’ve tested different products,” he says. “I want consumers to find these final products far more appealing than they are today – to the point where they say, this completely changed my opinion of what a plant-based burger, taco, or even a yogurt can taste like.”