Solar Foods receives positive EFSA scientific opinion for novel ingredient

The Finnish food technology company Solar Foods has received a positive scientific opinion from the European Food Safety Authority EFSA, concluding that the company’s new protein ingredient Solein® is safe under the proposed conditions of use.

Solar Foods considers this a groundbreaking milestone, taking the company a major step closer to commercialization of Solein in the significant protein market of the European Union. The opinion significantly de-risks the company’s commercialization plan and enables Solar Foods to advance European offtake negotiations, financing and preparations for the final investment decision for Factory 02. 

The European Food Safety Authority (EFSA) has concluded its scientific risk assessment for Solein and considers Solein safe to use as a protein ingredient in selected, strategic food categories. The EFSA opinion provides Solar Foods directional categories which are conditional to the European Commission's final authorization. Solar Foods is the first company in the world to receive a positive EFSA scientific opinion for a novel food ingredient produced through gas fermentation.

Solein is 80% protein, 6% fat (primarily unsaturated fats), 10% dietary fibers, and 4% mineral nutrients, and a good source of micronutrients like iron (1,1g/kg) and vitamin B12 (50 µg/kg).  (Source: Solar Foods)

The positive scientific opinion progresses Solar Foods’ novel food application to the final stage of the EU approval process. The European Commission will next draft an implementing act and present it to the Committee consisting of representatives of the EU Member States for its voting. No separate authorizations are required in individual member states. As an update to the previously communicated expectation of getting the regulatory approval during 2026, Solar Foods currently expects the remaining EU authorization process to take approximately 7–9 months, based on recent novel food authorization timelines. Following the authorization, Solein can be commercialized throughout the European Union under the approved conditions of use.

Positive opinion enables next steps in Solar Foods’ growth plan
The positive EFSA opinion removes a key regulatory uncertainty affecting commercial negotiations. Solar Foods expects the opinion to accelerate ongoing offtake negotiations towards binding agreements. Binding customer agreements and completion of the financing package are among the key prerequisites for the final investment decision on Factory 02, Solar Foods’ 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. After years of proving the technology, product and production process, our focus is increasingly on commercial execution and scaling the business,” says Rami Jokela, CEO of Solar Foods.

Europe represents a significant commercial opportunity
Europe represents a significant commercial opportunity for Solar Foods alongside the United States, where the company is already commercializing Solein. The total addressable market for Solein in the European Union is approximately EUR 7bn and in the United States EUR 11bn in 2030. The estimated market value growth is 8% annually, with the market defined as protein ingredients that go into the categories of Health, Performance, and Functional Foods.

Solein offers food manufacturers a versatile and nutritionally rich protein ingredient with a fundamentally different production method compared to traditional animal- and plant-based proteins. Produced through gas fermentation independently of agricultural land, weather and climate conditions, Solein offers the potential for predictable supply, consistent quality and reduced exposure to the supply and price volatility associated with traditional agricultural protein production.

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

Long and thorough regulatory process
Solar Foods submitted its EU Novel Food application for Solein to the European Commission on 29 October 2021. Since then, Solein has undergone an extensive scientific safety assessment by EFSA, during which Solar Foods has provided detailed information and scientific evidence on the product, its manufacturing process, and its safety for consumers.

Outside the European Union, Solein received novel food regulatory approval in Singapore in September 2022. In the United States, Solein obtained an independent conclusion of GRAS (Generally Recognized as Safe) status in 2024, enabling Solar Foods to commercialize Solein in the U.S. The company has also submitted a GRAS notification to the U.S. Food and Drug Administration (FDA) for its review to obtain the so-called No Questions Letter.