A Finland company has obtained the self-affirmed U.S. Generally Recognized as Safe (GRAS) status for its novel, all-purpose protein “grown with the air we breathe.” The company says it’s the first step in a process that could allow sale of the ingredient by the end of this year.
Solar Foods is the company, and its ingredient is called Solein. It’s made via a “unique bioprocess [that] takes a single microbe, one of the billion different ones found in nature, and grows it by fermenting it using air and electricity.
“Solein is a nutritionally rich and versatile ingredient which can replace protein virtually in any food. Solein can also be used as a fortifier to complement the nutritional profile of various foods: it can be a source of iron, fiber and B vitamins, and it can also bring different techno-functionalities into food products,” Solar Foods explained. Solein received a novel food regulatory approval that allows for the sale of food products containing Solein in Singapore in September 2022.
“Obtaining self-affirmed GRAS status is the first step towards entering the United States,” said Chief Commercial Officer Juan Benitez-Garcia. The FDA issued a no-objections letter. “We will shortly be able to launch commercial activities in this significant new market, including marketing and sales operations, and drive our growth.”
Solar Foods has conducted large-scale scientific research, and the results pertaining to food safety have been published in peer-reviewed scientific journals. Additionally, a qualified panel of experts has compiled a statement on the product’s safety and intended use based on determined food categories and Solein concentrations.
The next steps in Solein’s commercialization in the U.S. are to register the Solar Foods production facility Factory 01 with the FDA, which requires a food safety plan fulfilling the specific requirements, and to fulfill any other applicable requirements. “This will enable Solar Foods to start food export from Factory 01 to the United States. Solar Foods estimates sales could start by the end of this year.”
Solar Foods has also filed for novel food regulatory approvals for Solein in the UK and the EU.
