Enifer seeks Novel Food approval for PEKILO

Finnish biotech scaleup Enifer is the first Nordic company to apply for Novel Food approval for a mycoprotein ingredient. With its new production facility, set to be completed in 2025, Enifer will produce 3,000 tons of mycoprotein annually.

Espoo, Finland (October 31st, 2024) Finnish biotech scaleup Enifer has filed for Novel Food authorization from the European Food Safety Authority (EFSA) for its mycoprotein PEKILO® — marking a major milestone in the company’s mission to bring an innovative and eco-friendly protein to the European food market. Earlier this year, Enifer secured the funding for its first €33 million production facility, which is set to be completed by the end of 2025. The facility is expected to upcycle food industry side streams to produce up to 3,000 tons of sustainable fungi-based protein annually at full capacity.

PEKILO® mycoprotein is a nutrient-rich drop-in ingredient produced through a specialized fermentation process involving a unique strain of fungus, similar to the methods used in brewing or producing soy sauce. This process yields a neutral-tasting, neutral-colored mycoprotein powder rich in protein and fiber, making it ideal for a wide range of food products ranging from alternative meats to baked goods.

Originally developed in Finland in the 1970s, the PEKILO® fermentation process was designed to upcycle byproducts from the forest industry into animal feed ingredients. PEKILO® has been successfully used in feed for over 15 years, proving to be an excellent source of protein for livestock, particularly pigs and poultry. In the late 1970s and throughout the 1980s, PEKILO® was also studied and shown to have potential for human consumption. Allergenicity tests and sensory evaluations were conducted, and a 1984 study at MIT confirmed PEKILO®‘s suitability for human nutrition.

However, in the 1990s, PEKILO®’s journey was cut short by technical advancements in the forest industry, which meant suitable side streams were no longer available. Now, Enifer has revived and refined this pioneering technology, adapting it to utilize new raw material streams from the food and agricultural sectors while advancing the development of PEKILO® as a food ingredient for human consumption.

“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,” says Elisa Arte, Enifer’s Ingredient Development Manager.

In the EU, any food that has not been consumed to a significant degree before May 1997 is considered a Novel Food. While Enifer builds on the foundation of the original PEKILO® process, it is now entering new, uncharted territory with advanced technology and innovation. 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. Once authorized, this Finnish innovation can significantly impact global sustainable food production.

With the application submitted, a thorough risk assessment process will begin, which could take several years. Meanwhile, Enifer plans to pursue GRAS (Generally Recognized as Safe) status in the U.S. and seek novel food approval in Singapore. In preparation for the launch of PEKILO®, the company is actively collaborating with global partners, including Skretting (the aquafeed division of Nutreco), Purina (in the pet food industry), and Valio (for consumer food products).

“With the application now submitted, we’re excited to shift our focus on developing innovative products with our partners. PEKILO® has already shown remarkable versatility, and the possibilities are limited only by imagination,” adds Arte.