Solar Foods has cleared a major regulatory hurdle after EFSA issued a positive scientific opinion on Solein, the world’s first gas-fermented novel protein ingredient to reach this stage of EU authorisation.
Finnish food technology company Solar Foods has received a positive scientific opinion from the European Food Safety Authority (EFSA) confirming that its novel protein ingredient, Solein, is safe to consume under its proposed conditions of use.
The decision will be critical in the company’s mission to commercialise the ingredient across the European Union (EU), bringing Solar Foods closer to accessing a potential €7bn European market for protein ingredients used in health, performance and functional foods.
EFSA’s assessment concludes that Solein can be used as a protein ingredient in selected food categories. However, the scientific opinion is not the final regulatory approval. The application must now progress through the remaining stages of the EU’s Novel Food authorisation process before commercialisation can begin.
Solar Foods is the first company to receive a positive EFSA scientific opinion for a novel food ingredient produced through gas fermentation.
Final stage of EU regulatory approval
Following EFSA’s assessment, the European Commission will draft an implementing act and present it to a committee of representatives from EU Member States for a vote. Once authorised, Solein will be eligible for commercialisation across the EU under the approved conditions of use, without requiring separate authorisations from individual member states.
Solar Foods currently expects the remaining authorisation process to take approximately seven to nine months, updating its previous expectation of receiving approval during 2026.
The company submitted its Novel Food application on 29 October 2021 and has since provided scientific evidence and detailed information about Solein, its manufacturing process and its safety for consumers.
Commercial negotiations and production expansion
With the regulatory assessment complete, Solar Foods expects to advance ongoing discussions with potential customers towards binding offtake agreements.
These agreements, alongside completion of the company’s financing package, are key requirements for the final investment decision on Factory 02, its first industrial-scale Solein production facility.
“This is a defining moment for Solar Foods, as the positive opinion enables us to advance our offtake negotiations, financing and preparations for the final investment decision for Factory 02,” said Rami Jokela, CEO of Solar Foods. ”After years of proving the technology, product and production process, our focus is increasingly on commercial execution and scaling the business.”
Alternative protein production
Solein is produced through gas fermentation, using a production process that operates independently of agricultural land, weather and climate conditions.
Unlike conventional animal and plant-based protein production, the approach could offer food manufacturers a more predictable supply, consistent ingredient quality and reduced exposure to agricultural supply and price fluctuations.
Solar Foods estimates that the European market for Solein could reach €7bn by 2030, alongside an estimated €11bn opportunity in the United States. Both markets are projected to grow by approximately 8 percent annually.
“Europe is one of the world’s largest and most attractive protein markets and a strategically important market for Solein,” said Jokela. ”We are already in discussions with major international food companies and the positive EFSA opinion enables us to advance these discussions towards commercial agreements. Solein offers a compelling value proposition for food manufacturers in Europe.”
International regulatory progress
Solein has already secured regulatory milestones in other markets. Singapore granted novel food approval in September 2022, while Solar Foods obtained an independent Generally Recognized as Safe (GRAS) conclusion in the United States in 2024, enabling commercialisation there.
The company has also submitted a GRAS notification to the US Food and Drug Administration for review.
The positive EFSA opinion therefore represents an important step in expanding Solein’s international market access, although European commercialisation remains dependent on the final EU authorisation.
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