Solar Foods Oyj, press release 3 February 2025 at 15:00 EET
Solar Foods moves one step closer to introducing Solein® to the European market
Finnish food technology company Solar Foods has addressed inquiries from the European Food Safety Authority (EFSA) regarding the scientific opinion on the safety of Solein. This brings the company one step closer to introducing Solein to the European market.
Solar Foods submitted its application for Novel Food approval to the European Commission on 29 October 2021. Since then, the company has made significant progress in the EFSA application process. During the process EFSA is entitled to make inquiries. Responses to these latest EFSA inquiries were based on data obtained from Solein produced in Factory 01. The application process continues towards obtaining a final scientific opinion. Solar Foods has previously communicated that it expects to receive the EU Novel Food approval during 2026 and continues to anticipate this timeline is achievable.
"This marks a significant step forward in the European approval process with its rigorous safety assessment, bringing us closer to the launch of Solein in Europe. Based on our dialogue with EFSA, we anticipate the process is moving forward accordingly. We remain committed to the highest standards of safety and quality for our innovative protein product and look forward to completing the final stages of the approval process," says Troels Nørgaard, Chief Strategy Officer of Solar Foods.
In the European Union, novel foods are defined as foods that were not consumed to a significant degree within the EU before 15 May 1997 when the first novel food regulation was adopted to unify food laws in all member states. Each new food must go through a comprehensive application process to ensure it meets three key criteria: 1) it is safe for consumption, 2) it is not misleadingly labeled, and 3) it is nutritionally suitable for its intended use. The application process involves compiling a detailed dossier containing manufacturing data, product information, and supporting scientific evidence, which is then submitted to the European Commission (EC).
Solein received novel food regulatory approval in Singapore in September 2022. Additionally, in September 2024, Solein obtained the independent conclusion of GRAS (Generally Recognized as Safe) status - also known as self-affirmed GRAS - in the United States, enabling the company to initiate commercial activities in this significant market. 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 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.
Further information:
Troels Nørgaard, Chief Strategy Officer, troels.norgaard@solarfoods.com, tel. +45 69304082
Certified Advisor
Carnegie Investment Bank AB (publ)
Images for editorial use: www.solarfoods.com/media
About 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 and thereby converting carbon dioxide to protein. 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, fiber and B vitamins, and it can also bring different techno-functionalities into food products. www.solein.com.
About Solar Foods
Solar Foods produces protein using carbon dioxide and electricity. Solein® production, independent of weather and climate conditions, liberates global protein production from the constraints of traditional agriculture. Solar Foods was founded in Finland in 2017. The company is listed on the Nasdaq First North Growth Market Finland. www.solarfoods.com