Enifer secures self-affirmed GRAS status for PEKILO® mycoprotein in US
Self-affirmed GRAS (Generally Recognized as Safe) status is a process where a food ingredient manufacturer independently determines that their ingredient is safe for its intended use, based on a scientific evaluation by their own expert panel and publicly available data, without requiring the FDA’s prior approval or notification.
USA – Enifer, a Finnish biotech company focused on sustainable protein ingredients, has achieved self-affirmed GRAS (Generally Recognised as Safe) status for its flagship mycoprotein, PEKILO®, marking an important step in bringing the ingredient to the U.S. market.
The decision follows a review by an independent panel of food safety experts and positions the company to begin partnerships with American food manufacturers.
PEKILO® stands out from other mycoproteins because it is produced in a dry, powdered form rather than wet or frozen.
This makes it shelf-stable, easy to ship, cost-effective, and simple to incorporate into food production lines. Its versatility means it can be used in products such as plant-based meat and dairy alternatives, sports nutrition, and healthy snacks.
“Achieving self-affirmed GRAS status marks a major milestone in the commercialisation of our PEKILO® mycoprotein and its entry into the U.S. market,” said Elisa Arte, Head of Food Research and Development at Enifer. “We’re excited to start collaborating with U.S. food manufacturers to bring a high-quality ingredient that delivers both protein and dietary fiber.”
The milestone comes at a time when demand for sustainable proteins is growing quickly.
The global alternative protein market is expanding at around 14% annually, while the clean-label sector, built around simple and trusted ingredients, is projected to grow 15.5% per year through 2035.
Enifer believes PEKILO® can meet these consumer expectations by offering a neutral taste and color, strong water-binding properties, and balanced nutrition.
“Plant-based foods won’t win over consumers unless they are genuinely better than what came before,” said Simo Ellilä, CEO and co-founder of Enifer. “PEKILO® gives manufacturers the flexibility to improve texture, nutrition, and taste, while complementing proteins like soy and pea.”
Notified GRAS submission to FDA in the horizon
Enifer is also preparing a notified GRAS submission for FDA review, which would further validate the safety of PEKILO® for U.S. markets.
This move aligns with the FDA’s recently announced plan to introduce a mandatory GRAS notification system by 2026, aimed at strengthening oversight of new food ingredients.
Founded in 2020, Enifer builds on a fermentation technology first pioneered in Finland in the 1970s.
The company raised €36 million (approximately US$42 million) in 2024 to construct a commercial-scale facility, which is expected to open in 2026 with a capacity to produce 3,000 tonnes of mycoprotein annually.
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