Solar Foods clears EFSA hurdle for Solein as EU sales await 2027 authorization

Solar Foods has received a positive scientific opinion from the European Food Safety Authority (EFSA) for its gas fermentation protein Solein, clearing a key hurdle for European sales. The company now expects final EU authorization in 2027, revising its previous timetable.

• Solar Foods received a positive EFSA safety opinion for Solein.
• Final EU authorization is expected in 7-9 months.
• The opinion supports customer negotiations and Factory 02 financing preparations.

EFSA concluded that the ingredient is safe under its proposed conditions of use. The Finnish company said the finding would help advance customer negotiations, financing and preparations for an investment decision on Factory 02, its first industrial-scale Solein production facility.

The opinion does not yet permit sales in the European Union. Solar Foods now expects the remaining authorization process to take approximately 7-9 months, revising its previous expectation that approval would arrive during 2026. That would put authorization around June-August 2027, subject to completion of the process.

“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,” he said.

Solar Foods said it was the first company globally to receive a positive EFSA scientific opinion for a novel food ingredient produced through gas fermentation. Its application now moves to the final stage of the EU novel food approval process.

The European Commission will next draft an implementing act and submit it for a vote by a committee of representatives from EU member states. If authorized, Solein could be sold throughout the bloc under the approved conditions of use, without separate authorizations in individual countries.

The company said EFSA’s opinion covered use as a protein ingredient in selected food categories. Those categories remain subject to the Commission’s final authorization. Solar Foods based its revised timing estimate on recent novel food authorization timelines.

For Factory 02, the immediate commercial task is securing binding customer commitments. Solar Foods expects the opinion to help move ongoing offtake negotiations toward agreements, removing a regulatory uncertainty that has affected those discussions.

Binding customer agreements and completion of the financing package are among the prerequisites for the final investment decision. The company linked the regulatory progress directly to those preparations, with the European market forming an important part of its commercialization plans alongside the United States.

Solar Foods estimates that Solein’s addressable EU market will reach approximately €7 billion (US$7.8 billion) in 2030, compared with €11 billion (US$12.3 billion) in the USA. It defines that opportunity as protein ingredients used in health, performance and functional foods, and estimates annual market value growth of 8%.

“Europe is one of the world’s largest and most attractive protein markets, and a strategically important market for Solein,” Jokela said.

“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,” he said.

Solein is produced through gas fermentation. Solar Foods said the process operates independently of agricultural land, weather and climate conditions, offering manufacturers the potential for predictable supply and consistent quality, with less exposure to the supply and price volatility associated with conventional agricultural proteins.

The EFSA assessment follows an application submitted to the European Commission on October 29, 2021. During the review, Solar Foods supplied information and scientific evidence covering the ingredient, its manufacturing process and consumer safety.

Outside Europe, Solein received novel food regulatory approval in Singapore in September 2022. Solar Foods is already commercializing the ingredient in the United States following an independent conclusion of Generally Recognized as Safe (GRAS) status in 2024.

The company has also submitted a GRAS notification to the US Food and Drug Administration for review, seeking a 'No Questions Letter'. That review is separate from the independent GRAS conclusion under which US commercialization has begun.

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