Fermify, an Austrian precision fermentation company developing milk proteins, announces it has obtained self-affirmed Generally Recognized as Safe (GRAS) status for its precision-fermented casein after conducting a comprehensive safety study, as per FDA requirements.
The GRAS milestone validates the quality and safety of Fermify’s casein and is crucial for introducing animal-free cheese and dairy products to the US market. It also positions Fermify as one of the few suppliers of fermented casein in the country. The company says it has also voluntarily notified the FDA of its GRAS conclusion and is now pending a “no questions” letter confirming the status.
“This is a key development for Fermify and the entire precision fermentation sector. We are one of the first companies to sell their casein proteins in the USA,” said Eva Sommer, CEO and co-founder.
Tasting animal-free dairy
Founded in November 2021 by Sommer and Christoph Herwig, Fermify raised €5 million in 2023 to support and enhance its fermentation platform, and recently, it expanded an already closed seed round.
Fermify says it has been collaborating with dairy producers, including CREMER and Interfood, to test the functionality of its fermented proteins in various dairy products, including cheese, creams, foams, and drinks. Now that the company’s casein has been confirmed as safe for human consumption, companies can conduct sensorial experiments with consumers.
“We work intensely with our B2B customers on product development. We have a long waiting list for our animal-free casein; reaching this milestone is a key validation of the quality and safety of Fermify’s technology,” Sommer commented.
Reaching price parity by 2027
The Austrian biotech, aiming to reach price parity with cow-derived casein in 2027, implements a continuous precision fermentation process. Contrary to batch-fed fermentation, this continuous method is said to deliver 50% cost reductions, offering affordable and sustainable alternatives to current milk proteins. “Our productivity is 16 times higher than that of a fed-batch process,” she told Cultivated X in March.
In addition, its technology reduces CO2 by 85%, water usage by 75%, and land use by 98% compared to conventional cheese production. It also completely eliminates cows from the casein production process.
Fermify now joins Dermark’s 21st.BIO (whey), California’s New Culture (casein), Israel’s Remilk (whey), and Perfect Day (whey) in achieving GRAS status for their animal-free proteins.
“The FDA has been very cooperative in the process of preparing the food safety dossier. We discussed our process and product specification in a pre-submission call with experts from the FDA. This unique opportunity was very helpful for Fermify to assess the readiness of the casein production technology for the US market, and we are very thankful for their support,” Sommer added.
