New Culture has self-affirmed that its animal-free casein is Generally Recognized as Safe (GRAS) following a recent review by an independent panel of scientific and toxicology experts. The company's self-GRAS determination means its casein can be sold, used and consumed in the U.S.

This GRAS status is the result of New Culture casein matching the identity and macro-nutritional profile of the cow casein it replaces and being made from a manufacturing process that is reproducible, industry-standard and food safe, the company says. This manufacturing process, precision fermentation, has been used for decades to make food ingredients and pharmaceuticals cost effectively, sustainably and animal-free. New Culture intends to notify FDA of its self-GRAS determination in the near future.

New Culture says its animal-free casein offers the taste, texture and functionality of conventional dairy. Products with New Culture casein are free from lactose, cholesterol and trace hormones and antibiotics as well as reduce greenhouse gas emissions and land and water use.

New Culture says its first product—mozzarella for pizzerias—melts, stretches, bubbles and browns like conventional cheese and has the mouthfeel and texture that plant-based options lack. The company continues to scale its manufacturing capacity in preparation for the first sale of its cheese later this year, beginning at Nancy Silverton's Pizzeria Mozza in Los Angeles.

"Having secured another 'world's first' for our animal-free casein is a testament to the hard working and innovative team we have at New Culture," says Inja Radman, cofounder and CSO. "Achieving GRAS status proves that animal inputs aren't needed to produce casein protein and marks an essential step on our path toward commercialization."