Alternative protein company Solar Foods has obtained self-affirmed Generally Recognized as Safe (GRAS) status in the United States for its Solein protein ingredient.

The company said the milestone marks a major step toward Solein’s commercialisaton and entry into the US market. The ingredient received a novel food regulatory approval that allows for the sale of food products containing Solein in Singapore in September 2022.

Solein is a versatile, multipurpose protein ingredient developed using a unique bioprocess in which a single microbe, found in nature, is fermented using air and electricity. The result is a nutritionally rich ingredient which can replace protein in ‘virtually any’ food, according to Solar Foods.

It can also enhance various functional and textural attributes, and fortify the nutritional profile of many food products, providing a source of iron, fibre and B vitamins.

In the US, obtaining self-affirmed GRAS status is one of the procedures available for introducing new foods to the market. To achieve this, Solar Foods conducted large-scale scientific research, and the results pertaining to food safety have been published in peer-reviewed scientific journals. A qualified panel of experts has also compiled a statement on the product’s safety and intended use depending on determined food categories and Solein concentrations.

Solar Foods’ chief commercial officer, Juan Benitez-Garcia, said: “Obtaining self-affirmed GRAS status is the first step towards entering the United States. We will shortly be able to launch commercial activities in this significant new market, including marketing and sales operations, and drive our growth. So far this has been possible only in Singapore.”

The next steps in Solein’s commercialisation in the US will be to register the company’s production facility, Factory 01, with the US Food and Drug Administration (FDA). This requires a food safety plan fulfilling specific and applicable requirements. Solar Foods will then be able to start food export from the facility to the US. Following this, the start-up estimates that sales will begin by the end of this year.

Solar Foods then aims to obtain the ‘notified’ GRAS status, which means receiving a ‘No Questions Letter’ from the FDA. Solar Foods is required to make a notification with necessary reports on safety of the product for evaluation by the FDA. This status, which Solar Foods estimates it will obtain by the end of 2026, could widen possibilities for sales of Solein in the US and beyond.

“The United States will be a significant market for us,” Benitez-Garcia added. “GRAS status in the US will contribute to advancing Solein’s expansion into other markets that do not grant specific novel food approvals, such as Japan.”

Solar Foods has also filed for novel food regulatory approvals for Solein in the UK and the EU.

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