Finnish biotech company Enifer has asked the US Food and Drug Administration (FDA) to review the safety of its main mycoprotein ingredient Pekilo.
Enifer has already decided on its own that PEKILO qualifies as “Generally Recognized as Safe” (GRAS) in 2025.
By submitting a GRAS notice to the FDA, the company is now putting Pekilo into the FDA’s formal review process.
Enifer says this will help it work with more US food manufacturers as demand grows for high-protein, functional ingredients and products that mix plant and animal proteins.
Enifer head of food R&D Elisa Arte said: “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.
“At the same time, we are scaling production to ensure consistent, industrial volumes. In a market that has moved past hype and is now focused on unit economics and reliable capacity, regulatory clarity and manufacturing readiness must advance together. This step brings Pekilo into that commercial decision framework.”
Enifer produces its mycoprotein through a proprietary fermentation approach that it says was originally developed in Finland.
The company uses side streams from the food and agricultural industries as inputs, converting them into Pekilo, described as a dry, shelf-stable powder combining protein and fibre for use in a range of food formats.
According to Enifer, Pekilo contains up to 50% protein and 35% fibre, with a neutral taste and colour and an amino acid profile intended to suit broad applications.
The ingredient is positioned for use in areas such as healthy snacks, dairy and meat alternatives and hybrids, ready-to-eat products and baked goods.
Enifer argues that Pekilo can be incorporated as a “drop-in” ingredient, allowing manufacturers to make higher-protein and higher-fibre claims without changing sensory characteristics.
The company is expanding manufacturing in Finland and increasing its commercial efforts in the US.
Enifer expects the FDA review to run through 2026 while it talks to potential customers in several food categories.
