Finnish biotech start-up Enifer has filed for Novel Food authorisation from the European Food Safety Authority (EFSA) for its Pekilo mycoprotein ingredient.
The start-up said this latest development represents a significant milestone in its mission to bring an innovative, eco-friendly protein to the European food market.
Pekilo is described as a nutrient-rich drop-in ingredient, produced through a specialised fermentation process that involves a unique strain of fungus. The process yields a mycoprotein powder with a neutral taste and colour, offering a rich source of protein and fibre. It can be incorporated into a wide range of food products, from meat alternatives to baked goods.
The Pekilo fermentation process was originally developed in Finland in the 1970s, designed to upcycle byproducts from the forest industry into animal feed ingredients. While Pekilo has successfully been used in feed for over 15 years, it is now entering new territory with the discovery of its many potential use cases in human F&B products.
In the late 1970s and throughout the 1980s, Pekilo was studied and shown to have potential for human consumption. After allergenicity tests and sensory evaluations were conducted, a 1984 study at Massachusetts Institute of Technology confirmed its suitability for human nutrition.
Following this, in the 1990s, technical advancements in the forest industry meant that suitable side streams were no longer available. However, Enifer has now revived the original technology and adapted it to utilise new raw material streams from the food and agricultural sectors, while advancing the development of Pekilo as a food ingredient.
In the EU, any food that has not been consumed ‘to a significant degree’ before May 1997 is considered a Novel Food. As a result, Pekilo is considered a novel ingredient with a distinct production process, requiring evaluation and approval under the EU’s Novel Food regulations.
The application is now submitted and a thorough risk assessment process will begin, Enifer confirmed, which could take several years to complete. Meanwhile, the company plans to pursue Generally Recognized as Safe (GRAS) approval in the US, and seek novel food approval in Singapore.
In preparation for Pekilo’s launch, Enifer is collaborating with global partners including Skretting (the aquafeed division of Nutreco), Purina (in the pet food industry) and Valio (for consumer food products).
Earlier this year, the company secured funding for its first €33 million production facility set to be completed by the end of 2025. The site is expected to upcycle food industry side streams to produce up to 3,000 tons of fungi-based protein annually at full capacity.
Elisa Arte, Enifer’s ingredient development manager, said: “We’re incredibly proud to continue the work that visionary scientists began in the 1980s and to take this vital step towards bringing Pekilo to the market as a food ingredient. Our team has worked hard to compile the data needed to demonstrate Pekilo’s safety for human consumption, and we’re looking forward to starting the approval process with EFSA.”
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