The Finnish company Solar Foods is going through the regulatory hoops to be granted a “Generally Recognized as Safe” designation from the US Food and Drug Agency for its product, Solein®.

It has submitted a GRAS notification to obtain a no questions letter from the FDA for Solein®’s safety assessment. The notification follows obtaining the independent conclusion of GRAS status, also referred to as self-affirmed GRAS status, in September 2024, which enabled the company to initiate commercial activities in the United States.

Solar Foods, founded in 2017 with funding by the European Union – NextGenerationEU, is a Helsinki, Finland-based food technology company that was founded in a scientific research program at VTT Technical Research Centre of Finland and Lappeenranta University of Technology.

Solar Foods says its research team was then able to find a way to turn emission-free electricity and captured carbon dioxide into an edible source.

Food Business News says:

Solein, the company’s first product, is an all-purpose protein grown with air. The company said it uses a bioprocess that takes a single microbe and grows it by fermenting it using air and electricity.

In 2022, Solein was granted novel food regulatory approval in Singapore.

Reason magazine notes that, thanks to innovations in food science and agriculture, the world is producing more food than ever before. This has significantly reduced global hunger since the 1970s but has adversely affected the environment – in 2023, food production generated about 26 percent of global greenhouse gas emissions, according to Our World in Data.

Now scientists at the Finnish startup Solar Foods are turning air and electricity into food. The result? A mustard-colored protein powder made from naturally occurring microbes that could reshape how the world is fed.

Inside a bioreactor, a single microbe plucked from the Finnish dirt is fed a cocktail
of carbon dioxide, nitrogen, calcium, phosphorus, and potassium. Renewable electricity powers the process, which the company says is “20 times more efficient than photosynthesis,” and accelerates the growth of the microorganism into a protein-rich slurry.

After drying, what’s left is Solein: a fine powder packed with all nine essential amino acids, unsaturated fats, dietary fiber, and vitamin B12. According to Food & Wine, 100 grams of the powder yields 75 grams of protein, which is comparable to many whey protein powders on the market.

The company describes Solein as having a “pleasant note of umami flavor”.

It is said to require 600 times less water and 200 times less land to produce one kilogram of protein than is required to produce one kilogram of beef. The protein is also more efficient than other available vegan and plant proteins.

To obtain the no questions letter from the FDA, Solar Foods was required to submit the dossier including necessary documentation on the safety of the product for evaluation. Ae 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.

Sources: Reuters, Food Business News and Reason.