Onego Bio submits GRAS notice to FDA for precision fermentation-based egg protein

Finnish-US food ingredient firm Onego Bio has submitted a Generally Recognized as Safe (GRAS) notification to the FDA for its egg protein Bioalbumen, formulated through precision fermentation. The move bolsters the “first” non-animal egg protein’s entry to the global food market, with the company asserting that its amino acid sequence matches that of natural egg protein.

This comes amid rising demands for cage-free eggs from consumers and animal protection groups, pushing manufacturers to look for egg substitutes with a reliable and safe supply of high-quality protein.

Bioalbumen is produced using the fungi Trichoderma reesei and can be used as a “drop-in solution” across a wide range of applications where eggs are needed, such as baked goods, confectionery, pasta and ready-made meals.

“Our GRAS filing marks a significant milestone for Onego Bio, reinforcing our commitment to building a more resilient supply chain and sustainable food system,” says 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.”

Addressing egg supply chain issues

Ovalbumin is the primary protein found in egg white and has “exceptional” nutritional, functional and performance properties, notes Onego Bio.

Bioalbumen can be used as an egg replacement in baked goods, pasta and confectionery.Bioalbumen leverages precision fermentation to produce ovalbumin outside of the poultry supply chain. The company says it formulated the ingredient to address supply chain challenges of the US$300 billion global egg market.

Egg supply chain challenges began to arise in early 2022, exacerbated by the outbreak and spread of avian flu across Asian Pacific countries. This led governments to ramp up farm worker safety measures and halt poultry exports from infected farms.

In 2023, the Malaysian government removed price controls on eggs, allowing market forces to determine them. Further, in 2024, food tech company Revyve launched an egg replacer amid rising demand among manufacturers to swap eggs for more sustainable and ethical solutions.

Targeting environmental concerns

Bioalbumen is 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, claims Onego Bio. 

The ingredient also safeguards against the rising threat of Avian Flu on food security and public health, strengthening food security and supply chains in the US.