NEW TECH FOODS

Solar Foods has filed a GRAS (Generally Recognised as Safe) notification with the US Food and Drug Administration (FDA) for its microbial protein ingredient, Solein, as it seeks to secure a “no questions” letter confirming the product’s safety.

The submission builds on the company’s self-affirmed GRAS status for Solein, obtained in September 2024, which allowed Solar Foods to begin marketing and sales in the US.

To obtain FDA’s no questions letter, Solar Foods was required to provide a dossier containing safety data and supporting documentation. The agency will conduct a preliminary review before undertaking a scientific evaluation, during which it may request additional information.

If FDA raises no objections, it will issue the no questions letter, which will also be published in the agency’s GRAS inventory. Solar Foods expects to receive this by the end of 2026.

Troels Nørgaard, chief commercial and product officer at Solar Foods, said: “In the United States, there are several procedures available for introducing new foods to the market. After obtaining the self-affirmed GRAS status last year, we are now aiming to obtain the no questions letter from the FDA."

"This may widen the possibilities for sale of Solein as some potential customers may require this additional documentation. The no questions letter can also contribute to advancing Solein’s expansion into other markets that do not grant specific novel food approvals."

Solein is produced using Solar Foods’ proprietary technology, which converts carbon dioxide and electricity into protein-rich microbial biomass. The ingredient received its first regulatory approval in Singapore in 2022 and applications remain under review with UK and EU regulators.

Solar Foods anticipates receiving EU novel food approval in 2026, following an ongoing evaluation by the European Food Safety Authority (EFSA).

Top image: © Solar Foods