Solar Foods has obtained the GRAS (Generally Recognized as Safe) status, also referred to as self-affirmed GRAS status, for its all-purpose protein product Solein, in the US.
Solein is a nutritionally rich and versatile ingredient that can replace protein virtually in any food and can also be used as a fortifier to complement the nutritional profile of various foods.
Its production requires a unique bioprocess that involves a single microbe, one of the billion different types found in nature, grown by fermenting it using air and electricity.
The ingredient can be used as a source of iron, fibre and B vitamins, and can bring different techno-functionalities into food products.
In September 2022, the protein product received a novel food regulatory approval that allows for the sale of food products containing Solein in Singapore.
Solar Foods declared that ‘Solein is Generally Recognized as Safe’ for its intended use.
The company said the self-affirmed GRAS status is a major step towards Solein’s commercialisation and entry into the US market.
Solar Foods chief commercial officer Juan Benitez-Garcia said: “Obtaining self-affirmed GRAS status is the first step towards entering the US.
“We will shortly be able to launch commercial activities in this significant new market, including marketing and sales operations, and drive our growth.
“The US 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.”
Solein is a novel food that 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 viable practices for launching new food products into the market.
To obtain the self-affirmed GRAS status, Solar Foods has conducted large-scale scientific research and published the food safety results in peer-reviewed scientific journals.
In addition, a qualified panel of experts compiled a statement on the product’s safety and intended use based on determined food categories and Solein concentrations.
As the next steps in commercialising Solein in the US, Solar Foods will register a production facility, dubbed Factory 01, with the US Food and Drug Administration (FDA).
The registration requires a food safety plan addressing the specific regulatory requirements, and to satisfy any other applicable requirements.
After the registration, Solar Foods aims to obtain notified GRAS status, followed by receiving a ‘No Questions Letter’ from the US FDA, which is expected by the end of 2026.
Furthermore, Solar Foods has filed applications seeking novel food regulatory approval of Solein in the UK and the EU.
