Solar Foods announces that it has achieved self-affirmed Generally Recognized as Safe (GRAS) status for its air-based protein Solein in the USA. This milestone will allow the company to introduce the novel ingredient, offering a new alternative to animal and plant proteins. Claimed as the most sustainable protein in the world, the company expects its debut by the end of 2024.
“GRAS status in the US will contribute to advancing Solein’s expansion into other markets”
The biotech explains that it conducted large-scale scientific research, and the results about food safety have been published in peer-reviewed scientific journals. A panel of qualified experts has stated the product’s safety and intended use, explicitly detailing its application across various food categories and appropriate Solein concentrations.
Juan Benitez-Garcia, Solar Foods’ CCO, comments, “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.”
US sales by the end of 2024
Solar Foods anticipates starting sales by the end of this year, assuming other FDA requirements are met to export Solein to the US: registering the production facility, Factory 01, and delivering a food safety plan that meets specific and relevant requirements.
In addition to self-affirmed GRAS status, the biotech company will seek the FDA’s No Questions Letter. This recognition is not required to commercialize products but might widen the possibilities for selling the ingredients.
Solein is said to offer 65-70% protein, 5-8% fat, 0-15% dietary fiber, and 3-5% mineral nutrients. It also contains iron and B vitamins. It can be used as a raw material for enhanced foods, from noodles to baked goods and beverages to meat, dairy, and egg alternatives. Made by precision fermentation using microbes, carbon dioxide, and electricity, the process utilizes significantly fewer resources and boasts a minimal carbon footprint.
Solein’s expansion
Solein received novel food regulatory approval in September 2022 in Singapore, where the protein has launched in restaurant meals, ice cream, and a unique chocolate bar. Recently, in partnership with the Japanese giant Ajinomoto, the company unveiled Japanese-style sweets.
The company has also filed for novel food regulatory approvals in the UK and the EU. And recently, Solar Foods announced plans to list on the Nasdaq First North Growth Market Finland as part of its global growth strategy.
Benitez-Garcia adds, “The United States will be a significant market for us. 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.”