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Sustainable Protein for Europe: Enifer Files for Novel Food Approval with EFSA


Finnish biotech company Enifer has recently taken a significant step towards reshaping the European food industry by applying for Novel Food approval with the European Food Safety Authority (EFSA) for its mycoprotein ingredient, PEKILO®. The move makes Enifer the first company in the Nordic region to seek authorization for a mycoprotein, aiming to introduce an innovative and eco-friendly protein alternative to the European market. Expected to complete its first production facility by 2025, Enifer is gearing up to produce up to 3,000 tons of mycoprotein annually.


The PEKILO® Process: A Finnish Invention Reimagined


PEKILO® mycoprotein is derived from a specific fungal strain, cultivated through a specialized fermentation process. This process, similar to those used in brewing and soy sauce production, results in a nutrient-dense, neutral-flavored, and pale-colored powder high in protein and fiber. These characteristics make PEKILO® suitable for a wide range of food products, from meat alternatives to baked goods and snack items.


This innovative approach to protein production has its roots in Finland’s forest industry of the 1970s. Originally developed to upcycle byproducts from this industry into protein-rich animal feed, PEKILO® was successfully used as a nutritious feed ingredient for livestock, especially for pigs and poultry. Initial research into its application in human food consumption began in the late 1970s, with studies confirming its potential through allergen testing and sensory evaluations. In 1984, a study at the Massachusetts Institute of Technology (MIT) supported PEKILO®’s nutritional suitability for humans.


Revival and Redesign for Modern Food Needs


While the original PEKILO® project was put on hold in the 1990s due to shifts in the forest industry, which reduced the availability of suitable byproducts, Enifer has now revived and refined this fermentation process. The company has adapted it to utilize raw materials from the food and agriculture sectors, making it an efficient and eco-friendly solution for today’s protein demands. Enifer’s new approach aligns with the sustainability goals of reducing waste and optimizing resources by upcycling byproducts into food-grade protein.


This modernized PEKILO® process and Enifer’s application for Novel Food authorization represent a critical move toward diversifying Europe’s protein sources while offering a product that aligns with contemporary environmental goals.


Seeking Novel Food Approval: Navigating Europe’s Food Regulations


In Europe, any food or food ingredient not widely consumed before May 1997 is classified as “Novel Food” and must undergo a rigorous evaluation process to assess its safety and quality. Enifer’s application includes extensive data to support PEKILO®’s safety for human consumption. This documentation reflects Enifer’s dedication to meeting regulatory standards, including research into PEKILO®’s allergenicity, digestibility, and nutritional benefits. With EFSA’s approval process underway, Enifer is also actively pursuing GRAS (Generally Recognized as Safe) status in the United States and seeking similar approval in Singapore, aiming to position PEKILO® as a globally accessible protein ingredient.


As Elisa Arte, Enifer’s Ingredient Development Manager, explains, “We’re 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.”


Building a Sustainable Protein Future: Collaborations and Production Plans


Enifer’s upcoming production facility, financed through a €33 million investment, is scheduled to be completed by the end of 2025. The plant is designed to produce up to 3,000 tons of PEKILO® mycoprotein annually by transforming side streams from the food industry into sustainable protein. This scale of production marks a substantial entry into the European market, where demand for alternative proteins is growing, driven by consumer interest in health, sustainability, and reduced environmental impact.


The company has established partnerships with global industry leaders to advance the development and application of PEKILO® in various food and feed products. Collaborations with Skretting, a division of Nutreco that focuses on aquafeed; Purina, a pet food company; and Valio, a well-known dairy company, demonstrate PEKILO®’s versatility. Enifer is exploring ways to incorporate its mycoprotein into diverse products, from animal and pet feeds to consumer foods, broadening its reach in multiple markets.


Arte adds, “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.”


Looking Forward: PEKILO®’s Potential Impact on the Food Industry


Enifer’s revival of PEKILO® aligns with a broader trend in Europe toward plant-based and alternative proteins as sustainable solutions for feeding a growing population. With the Novel Food approval in progress, Enifer is positioned to become a leading player in the sustainable protein sector. This initiative showcases a unique approach to resource optimization and environmental stewardship, offering a promising solution for reducing reliance on traditional protein sources with high environmental footprints.


As Enifer moves toward its production goals and navigates the regulatory landscape, the company’s efforts illustrate the growing momentum in the biotech and alternative protein industries toward developing foods that prioritize both health and environmental impact. PEKILO® mycoprotein, as a versatile and eco-conscious protein option, highlights the role of biotechnology in the future of food, from ingredient innovation to sustainable production methods.

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