Finnish startup, Solar Foods, has obtained Generally Recognized as Safe (GRAS) status in the United States for its all-purpose protein grown from air, Solein. The company stated this is a major step towards Solein’s commercialisation and entry into the US market.
Since 2017, Solar has been developing its protein, made from a single microbe fermented using air and electricity. With just carbon dioxide, hydrogen, oxygen, and small amounts of nutrients, the company can grow 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, fibre and B vitamins, and it can also bring different techno-functionalities into food products.
It is not the only organisation working on this kind of technology, with Coca-Cola Europacific Partners investing in research from University of California Berkeley on new technology to convert air into sugar in 2022.
As a novel food, Solein requires regulatory approval in most markets before it can be sold and used in food and beverages. In the US, obtaining self-affirmed GRAS status is one of the procedures available for introducing new foods to the market.
In order to obtain self-affirmed GRAS status, 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.
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,” said Benitez-Garcia.
“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.”
The company received a novel food regulatory approval that allows for the sale of food products containing Solein in Singapore in September 2022, and Solar Foods has also filed for novel food regulatory approvals for Solein in the UK and the EU.
The next steps in Solein’s commercialisation in the US are to register the Solar Foods production facility Factory 01 with the U.S. Food and Drug Administration (FDA), which requires a food safety plan fulfilling the specific requirements, and to fulfil 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.
After this, Solar Foods aims to obtain the so-called notified GRAS status, which means receiving the so-called No Questions Letter from FDA. To this end Solar Foods is required to make a notification with necessary reports on safety of the product for evaluation by the FDA. This status may widen the possibilities for sale of Solein, as some potential customers may require the go-through of this procedure. Solar Foods estimates it will obtain the No Questions Letter by the end of 2026.
