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Translation: Original published in Finnish on 11/10/2026 at 9:30 am EET.
Solar Foods announced on Monday that it has received a positive scientific opinion from the European Food Safety Authority (EFSA) regarding the safety of the Solein protein. We view this as a significant and expected milestone in the company’s investment story because it clearly reduces the regulatory risk associated with entering the European market and facilitates negotiations on customer agreements. However, the company also refined its schedule estimate for final marketing authorization, leading us to believe that the investment decision for industrial-scale Factory 02 will be postponed until next year as well.
The positive scientific opinion from EFSA is a critical step for Solar Foods regarding Solein's entry into the European market, and it confirms that Solein is safe to consume under the proposed conditions of use. Although final approval from the European Commission for market entry is still pending, we believe that EFSA's opinion removes the key uncertainty from the path to market entry. The current EU novel food regulation has been in place since early 2018, and, to our knowledge, no application that has received a positive EFSA opinion like Solein's has ever been rejected (although the sample size is limited).
Europe is a key strategic market for the company alongside the US, so reducing regulatory risk in Europe naturally improves the investment case. The company estimates that the total addressable market for Solein (protein ingredients in Health, Performance, and Functional Foods) will be approximately 7 BEUR in Europe and 11 BEUR in the United States in 2030. The market is expected to grow by about 8% annually. In addition, the positive opinion enables the advancement of ongoing customer negotiations (e.g., supply agreements for Factory 02), can open doors for new customer negotiations, and will further promote the market introduction of Solein in other market areas as well.
EFSA's opinion, published on Monday, contained a lot of interesting information about Solein as a food item and its future applications. EFSA's positive opinion covered the following applications and their maximum Solein concentrations for them: cereal bars plain (maximum 20 g/100 g), fermented functional drinks (including fermented infusions) and fortified bottled water (9 g/100 g), ice cream, milk-imitate based (3.5 g/100 g), and mayonnaise sauce (1 g/100 g). However, we understand that the company is also planning to submit a new application to expand the uses of the product in the future.
We have previously noted that Solein's high mineral content (including iron, manganese, and nickel) could potentially limit its use as an ingredient. According to our interpretation, however, the usage volumes in EFSA's opinion are limited by a safety margin based on toxicity studies rather than minerals. Since no adverse effects were observed in the study, even at the highest tested dose, a new study using higher doses and a subsequent EFSA assessment could allow for higher Solein concentrations or new application categories.
However, in EFSA’s opinion, Solein protein quality was assessed as fairly poor based on amino acid digestibility. According to the in vitro assay reported in the EFSA opinion, Solein’s DIAAS score (digestible indispensable amino acid score) is 54–57%, while the threshold for good-quality protein is 75%. Based on this measure, despite Solein's complete amino acid profile, it is not classified as a high-quality protein source like whey protein. However, as we understand it, the figure presented in the statement is based on the results of Solein produced at the pilot plant, and the ingredient produced at the 01 demonstration plant achieves higher results. We would like the company to provide greater visibility regarding this key metric in the future, as we consider it a key product feature in terms of the product’s competitiveness in Solar Foods' focus category of health and performance.
In connection with the EFSA opinion, Solar Foods revisited its estimate of how long the final stage of the EU approval process would take. The company previously estimated that it would receive novel food approval in 2026, but the remaining process is now expected to take 7–9 months. According to our estimate, this delay will also postpone the final investment decision for Factory 02, which the company had previously targeted for the current year. We believe that binding customer agreements are prerequisites for securing financing and making the investment decision for Factory 02, and securing these agreements may require final marketing authorization in Europe. While the presumed postponement of the investment decision is slightly disappointing, we consider the reduction in regulatory risk to be a more important factor in terms of the investment story
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