Finnish startup Enifer sets sights on U.S. protein market: 'This is really significant for us'

Finnish biotech scaleup Enifer has cleared a crucial hurdle on its path to commercializing its flagship mycoprotein ingredient in the United States as it seeks to carve out a share of the fast-expanding market for alternative proteins.

The company announced Tuesday it has achieved self-affirmed GRAS (Generally Recognized as Safe) status, enabling it to begin selling its fungi-based mycoprotein to U.S. food manufacturers.

"This is really significant for us because this is the first time that we are able to commercialize our mycoprotein in food," Enifer CEO Simo Ellilä tells Impact Loop in an interview.

While Enifer is pursuing full FDA approval, the self-affirmed route cuts down the waiting time significantly when it comes to having products on the shelf in the U.S. Several peers, including Better Meat Co. and Meati, have already used the mechanism to launch into the U.S. market.

The company plans to focus initially on the pet food sector, with its first commercial-scale plant in Finland scheduled to open in 2026 with a capacity of 3,000 tonnes per year.

Pet food makes a strategic entry point

"We want to build that off-take base in pet food, which is also significantly faster to build than in food,” Ellilä said. “In the meantime, we also want to start building up a client base in food, so we will be producing smaller volumes of food-grade ingredients in order to build those customer relationships."

The company expects its first pet food products to appear on shelves in 2026, with some launches previewed at the trade fair Interzoo in May.

The potential market is vast. Even at full capacity, Enifer’s factory would account for only a small fraction of the premium pet food segment in Europe alone, according to Ellilä. Beyond pets, the company sees opportunities in sports nutrition, snacks, and everyday staples like pasta and breakfast cereals.

"Our protein is so versatile so we can include it in so many types of products,” he says. “We are in the process of narrowing in on what we should focus on as the best possible first-use cases. There is a big demand for snacks like protein bars, so that could be one early potential output."

The company’s mycoprotein PEKILO is a dry, shelf-stable protein powder that it touts as a neutral-tasting, high-fibre complement to soy and pea proteins. Ellilä argues that its ability to improve texture and mask "off-flavours" gives manufacturers more flexibility in plant-based applications.

Enifer makes its protein from mycelium, the root network of fungi, using a fermentation process that was first developed in the 1970s as an upcycling solution for the pulp and paper industry, which was later adapted for animal feed.

"The unique part of our company is the history. The core fermentation process is way, way older than our company. We call it the original mycoprotein because it was commercialized 10 years before Quorn."

Incentive to move across the Atlantic

The company already has a permit to sell products for animal nutrition in Europe, but Ellilä voiced frustration with the EU’s slower regulatory machinery.

Enifer filed for approval for food products more than a year ago, but expects to wait two or three more years before that process is finished.

So while Robert F. Kennedy Jr., the controversial U.S. Health Secretary, is trying to eliminate the self-GRAS pathway for the American market, Ellilä said it currently serves as an incentive for European startups to move across the Atlantic.

"This difference in regulatory environments drives European innovation to the U.S.," he says. “Some biotech startups are taking their whole production there, not just their sales. For a startup, time to market permeates everything. Investors are used to taking technology risks, but when they also have to take regulatory risk, everything becomes more difficult."