Onego Bio Submits Formal GRAS Notification to FDA for Bioalbumen ®

Onego Bio, a Finnish-U.S. food ingredient company, announced the submission of its Generally Recognized as Safe (GRAS) notification to the U.S. Food and Drug Administration (FDA) for its non-animal ovalbumin, produced through precision fermentation using Trichoderma reesei, and branded as Bioalbumen^®. This milestone marks a critical step toward bringing the first non-animal egg protein with an amino acid sequence identical to the natural protein, to the global food market.

Ovalbumin, the primary protein found in egg white, is known for its exceptional nutritional, functional, and performance properties. Onego Bio's breakthrough Bioalbumen^® offers a sustainable solution, leveraging precision fermentation to produce ovalbumin outside of the poultry supply chain. This ingredient was created to address supply chain challenges of the $300B global egg market.

“Our GRAS filing marks a significant milestone for Onego Bio, reinforcing our commitment to building a more resilient supply chain and sustainable food system” said Maija Itkonen, CEO of Onego Bio. “By supplementing traditional agricultural inputs, we can help alleviate future supply chain risks and price fluctuations and provide significant benefits to human health and safety and the environment."

The GRAS notification process is an important step in demonstrating that Onego Bio's Bioalbumen^® complies with the FDA's safety standards for its intended uses. It is intended as a drop-in solution across a wide range of applications where eggs are needed, including baked goods, confectionery, pasta, and ready-made meals.

By using fermentation to produce Bioalbumen^®, Onego Bio offers a scalable and environmentally friendly solution that reduces greenhouse gas emissions by 89%, land use by 95%, and water consumption by 87% compared to conventional egg production, while safeguarding against the rising threat of Avian Flu on food security and public health, strengthening food security and supply chains in the U.S.

About Onego Bio

Onego Bio is a Finnish-U.S. food ingredient company on a mission to create a more resilient food system through its product Bioalbumen^®—the first non-animal egg protein with an amino acid sequence identical to the natural protein. Made through precision fermentation, Bioalbumen^® matches the taste, nutrition, and functionality of the main protein fromtraditional eggs with an environmental impact around 90% smaller. Its unmatched versatility makes it ideal across a wide range of applications, while providing greater cost and supply stability for food manufacturers. Learn more at www.onego.bio.

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