Solar Foods progresses toward Solein approval in the European market

Solar Foods has taken another step toward bringing Solein, its microbial protein, to the European market. The Finnish food technology company has addressed inquiries from the European Food Safety Authority (EFSA) regarding the scientific opinion on Solein’s safety, marking continued progress in the EU Novel Food approval process.

Solar Foods submitted its Novel Food application to the European Commission on 29 October 2021. The process includes EFSA’s comprehensive safety assessment, during which the authority may request additional data. The latest responses were based on Solein produced at Factory 01, Solar Foods’ first commercial-scale production facility. The company continues to expect regulatory approval in 2026, in line with previous projections.

“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,” commented Troels Nørgaard, Chief Strategy Officer at 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.”

Under EU Novel Food regulations, foods that were not widely consumed in the EU before 15 May 1997 must undergo scientific and regulatory evaluation before entering the market. Each application must demonstrate that the product is safe for consumption, is not misleadingly labeled, and is nutritionally suitable for its intended use. The process requires a detailed dossier including manufacturing data, product information, and scientific evidence. Once EFSA completes its review, a final decision is made by the European Commission and member states.

While awaiting EU approval, Solar Foods has already secured regulatory clearances in other key markets. Solein was approved as a novel food in Singapore in September 2022 and self-affirmed GRAS (Generally Recognized as Safe) status in the USA in September 2024. The US market is a key focus for the company, particularly within the Health & Performance Nutrition segment, which consumes around 500 kilotons of protein powder annually.

As Solar Foods advances toward EU market entry, Solein is positioning itself as a sustainable, high-quality protein source that meets the growing demand for environmentally friendly nutrition.