Solar Foods Oyj, press release 16 September 2025 at 9.45 am EEST
Solar Foods has submitted a GRAS notification on Solein® in the United States to obtain a no questions letter from the FDA
Solar Foods has submitted a GRAS (Generally Recognised as Safe) notification to the United States Food and Drug Administration (FDA), aiming to obtain a no questions letter 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.
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. The FDA will first conduct a preliminary check for the notification, after which the core scientific evaluation will begin. During the process, the FDA can ask further questions and request additional information. In the end of the process, the FDA will issue the so-called no questions letter if they have no questions to the safety of the ingredient under the proposed conditions of use. The GRAS dossier will also be made publicly available in the FDA's GRAS inventory. Solar Foods estimates it will obtain the no questions letter by the end of 2026.
"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", says Troels Nørgaard, Chief Commercial & Product Officer at Solar Foods.
The so-called FDA-notified GRAS follows obtaining the self-affirmed GRAS status for Solein in September 2024. This allowed Solar Foods to launch commercial activities, including marketing and sales operations, in the United States. In order to obtain the self-affirmed GRAS status, Solar Foods conducted large-scale scientific research, and the results pertaining to food safety were published in peer-reviewed scientific journals. Additionally, a qualified panel of experts compiled a statement on the product's safety and intended use based on determined food categories.
Solar Foods has an initial focus on the Health & Performance Nutrition segment in the United States, which is one of the primary global markets for high-protein products. This $10bn core segment consumes approximately 500 kilotons of protein powder annually and has shown consistent growth driven by health, nutrition and fitness trends. Solein is setting the course to become the new standard in environmentally friendly nutritional protein.
Solein, produced by Solar Foods, is a novel food that requires regulatory approval in most markets before it can be sold and used in food and beverages. Solein received novel food regulatory approval in Singapore in September 2022. Solar Foods has also filed for novel food regulatory approvals for Solein in the UK and the EU. After submitting its application for novel food approval to the European Commission on 29 October 2021, the company has made significant progress in the EFSA and the UK application processes. The EFSA application process continues towards obtaining a final scientific opinion, and Solar Foods expects to receive the EU Novel Food Approval during 2026.
Additional information:
Troels Nørgaard, Chief Commercial & Product Officer, troels.norgaard@solarfoods.com, tel. +45 69304082
Images for editorial use: www.solarfoods.com/media
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What is Solein?
Solein is an all-purpose protein grown with the air we breathe: The unique bioprocess takes a single microbe, one of the billion different ones found in nature, and grows it by fermenting it using air and electricity. Solein is 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. Learn more at www.solein.com.
About Solar Foods
Solar Foods produces Solein®, a protein created using carbon dioxide and electricity. This innovative production method is independent of weather and climate conditions, eliminating the need for traditional agriculture. Founded in Finland in 2017, Solar Foods is listed on the Nasdaq First North Growth Market Finland. Learn more at www.solarfoods.com and investors.solarfoods.com.
