Enifer submits PEKILO mycoprotein for FDA GRAS review

At a Glance

Finnish biotech firm Enifer has filed a notified GRAS dossier with the U.S. Food and Drug Administration for PEKILO, its fermentation-derived mycoprotein ingredient. The submission follows a 2025 self-affirmed GRAS determination and positions the company for large-scale supply agreements with American food manufacturers. PEKILO, a shelf-stable powder containing up to 50% protein and 35% fiber, is produced by converting food and agricultural side streams through a proprietary process originally developed in Finland in the 1970s. Enifer expects the FDA review to continue throughout 2026, concurrent with the completion of a commercial-scale production facility in Kirkkonummi, Finland.

Key Details

• Enifer's GRAS filing aims to secure FDA "no questions" status, which would remove a key procurement barrier for U.S. food manufacturers operating under strict compliance frameworks.
• PEKILO is designed as a drop-in ingredient for applications including snacking, dairy and meat products and hybrids, ready-to-eat snacks, and baked goods, with a neutral taste and color profile.
• The company has raised nearly €60 million to date and is building a commercial-scale facility in Finland slated for completion in 2026.
• Enifer has also applied for novel food approval in the EU, the UK, and Singapore, and has validated its ingredients with partners including Skretting, Purina, and Valio.
• The global protein ingredients market is projected to grow from approximately $75 billion in 2022 to more than $125 billion by 2031.

Top Quote

"Large food manufacturers operate within strict procurement and compliance frameworks. FDA-notified GRAS status removes a key internal barrier, allowing ingredient discussions to move beyond technical sampling into long-term supply planning." —Elisa Arte, Head of Food R&D at Enifer