Finland’s Solar Foods is moving closer to regulatory approval in the EU after addressing inquiries from the European Food Safety Authority (EFSA) regarding the safety of its air-based protein, Solein.
The company submitted its novel food application back in 2021, providing a detailed dossier containing manufacturing data, product information, and supporting scientific evidence. Solein is currently undergoing a comprehensive application process to ensure it is safe for consumption, not misleadingly labeled, and nutritionally suitable for its intended use.
Solar Foods reports it has made significant progress in the EFSA application process, recently responding to inquiries based on data obtained from Solein produced at the company’s Factory 01 (reportedly the world’s first commercial air-based protein facility). Solar Foods is now awaiting a final scientific opinion, and expects to receive EU Novel Food approval in 2026.
Solein previously received regulatory approval in Singapore in 2022, and achieved self-affirmed GRAS (generally recognized as safe) status in the US last year. Solar Foods intends for Solein to become a “new standard in environmentally friendly nutritional protein”; in the US, the company will initially focus on the Health & Performance Nutrition segment, which consumes approximately 500 kilotons of protein powder annually and has shown consistent growth.
“Significant step forward”
Solein is produced using CO₂, hydrogen, and nitrogen as primary inputs, with energy sourced from renewable electricity. This process allows for protein production independent of traditional agriculture.
Last month, Solar Foods appointed Rami Jokela, who has extensive experience in scaling international businesses, as its new CEO. He succeeds founding CEO Pasi Vainikka, and will lead the company as it moves from research and development into global commercialization.
In August 2024, Solar Foods announced it would list on the Nasdaq First North Growth Market Finland, supporting its ambitious growth plans. The same month, the company announced a partnership with Japanese food manufacturer Ajinomoto Group to launch two new products made with Solein in Singapore.
“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,” says Troels Nørgaard, Chief Strategy Officer of Solar Foods. “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.”
