For Finnish startup Solar Foods, getting FDA approval in September for their first product was bittersweet. “We are really sad that we weren’t able to do it in the European Union first, because we’re a European company,” says CEO Pasi Vainikka. As well as being based in the EU, Solar Foods has received EU funding as a hydrogen-related company considered to be of common European interest.
Solar Foods’ product, Solein, sounds sci-fi but looks unassuming. This protein powder is produced by a microorganism found in the Baltic Sea, which essentially feeds on hydrogen, carbon dioxide, ammonium, and oxygen in bioreactors. The end result is a golden powder that looks like ground turmeric, tastes faintly of mushrooms, and turns a vanilla ice cream pistachio-green.
The point is to have a nutritionally rich source of protein that uses a fraction of the land and water as animal protein, and emits a fraction of the greenhouse gases – though the actual numbers are debated. Overall, says Julia Martin, the cellular agriculture lead for ProVeg International, “Collectively with other fermentation-derived proteins, we think that CO2-hydrogen fermented biomass has great potential in becoming one of many solutions moving forward to diversify our protein sources.”
So far Solein has not been used in meat substitutes. It has been added to ice cream and cookies in Singapore, yet generally most people aren’t looking to confectionery for their protein. The real value, both monetary and environmental, would be in replacing existing animal protein sources.
As with many innovative food companies, prices will depend on the ability to scale up, and that will depend on a fickle market. The company is targeting a cost of EUR 2.80–3.40/kg – pricier than soy concentrate, but cheaper than pea isolate, according to Vainikka. “Is this astronomically expensive? I don’t think so.”
It’s an energy-intensive process, and electricity makes up 50% of Solar Foods’ production cost. But in general, Finland has the possibly surprising advantage of among the lowest industrial electricity prices in the EU, with the biggest share of its power generated by nuclear. And like fellow microbial protein producers Air Protein and Farmless, Solar Foods is powered by renewable energy.
Cofounder Vainikka, a former energy researcher himself, likes to tell visitors to Solar Foods’ factory that given its direct air capture facility, even guests’ breathing provides CO2 to feed the special bacteria. The factory (aspirationally called Factory 01) is attached to Solar Foods’ sleek, black-and-white headquarters in the Helsinki metropolitan area. With its gleaming reflective black floor and the vast white wall used to project images, the building resembles a design hotel rather than a food company.
“It was really positive to see Solar Foods get self-affirmed GRAS [Generally Recognized as Safe] status in the US this September, and hopefully start proving the impact of this technology in North America,” Martin comments. The European Food Safety Authority (EFSA) and the EU “will move at a different speed, and it will likely be a longer timeline before we see green light given to this technology in the EU.”
This article outlines why that might be.
Ok-ed in Singapore and the U.S., pending in the U.K. and EU
Solein was approved in Singapore in October 2022, in a world-first approval of a gas-fermented microbial protein. Solar Foods has also applied for approval in the U.K. and the EU. The September 2024 authorization in the US took the self-affirmed Generally Recognized as Safe (GRAS) route. California’s Air Protein reports that it has also secured self-affirmed GRAS status for its first ingredient.
In plain English, this means that a company declares that it meets the safety standards set by the Food and Drug Administration (FDA). The FDA may continue to monitor the product after GRAS status. In the other GRAS option, FDA-notified, the FDA tells the company that its product is safe rather than the other way around.
Solar Foods says that once its factory is registered with the FDA, it will be able to start exports to the U.S. But it’s aiming for FDA-notified GRAS status too, because this opens more doors.
Seth Roberts, the senior policy manager for the Good Food Institute (GFI) Europe, advises novel protein producers to go through more regulatory processes where possible. “It gives you that…gold stamp to then go to market with,” Roberts says. Especially where consumers are new to a food technology and are slightly skeptical, going the extra mile may help to alleviate their concerns.
However, going the extra mile can be tough when the race itself is a marathon. Vainikka’s frustration is clear when he talks about the complicated regulatory process in the EU, which he believes is subject to political influence by lobbies and governments that are hostile to meat alternatives.
The EU’s novel foods regulator, EFSA, is based in Italy, whose government has attempted a pre-emptive ban on cultivated meat. Despite this being legally dubious, Hungary, Romania, and France have been inspired to follow suit.
EFSA is an independent, nonpolitical organization that fields about 40 applications for novel foods each year. EFSA “probably is the gold standard globally in terms of the food safety considerations, in terms of the confidence that it gives us as consumers,” according to Roberts.
The first step is for a company to submit a safety dossier to EFSA and the European Commission’s unit on novel foods, explains Ermolaos Ververis, a food chemist who is now a scientific officer in EFSA’s Food and Innovation Unit. They assess the dossier first on administrative grounds, making sure that the information is complete.
With this suitability check, “this time is very much dependent on the quality of the dossier received,” Ververis says. “In the field of novel foods, we see very, very big variation in regard to quality.” EFSA is attempting to provide particular help to small and medium enterprises as they build their dossiers. And in September, the agency published new guidance on submitting applications for novel foods.
In Solar Foods’ case, the company claims that the eligibility check alone took two years, during which their safety dossier was sitting unopened, until an EU agriculture official nudged it along. The OpenEFSA website, which logs the milestones of the review process, indicates that the dossier was received in February 2022 and declared valid in August 2023. In October 2023 EFSA requested further data from the company.
Solar Foods has declined to comment on this or other details of its interactions with regulators, referring to them as matters that can only be communicated “through our official investor channels.”
What Solar Foods is now in the midst of in the EU is the risk assessment phase: a scientific exercise that looks at things like the nutrition, allergenicity, and toxicity of a novel food item. EFSA is legally required to complete this within nine months, though the clock stops when it requests further information, as it has with Solar Foods.
This phase includes a public consultation. In Solar Foods’ case this consultation had only one comment, from a critic of novel proteins querying the health impacts of consuming the polymer polyhydroxybutyrate (PHB). This is an example of a substance where EFSA hasn’t published specific guidance on acceptable levels, and thus would evaluate as part of the risk assessment.
The risk assessment produces a scientific opinion, after which comes the risk management phase. These are separated so that “the risk assessment maintains the scientific rigor that is not to be affected from political decisions,” Ververis stresses.
In the risk management period, the European Commission prepares a draft implementing decision based on EFSA’s scientific opinion. Then the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee), which includes representatives of all EU member states, votes on whether it agrees with the decision. 15 of the 27 member states, representing at least 65% of the EU’s population, have to agree for a decision to be carried.
“I think that is the stage of the process where there is a way in which the process can become political,” says Roberts. This phase can consider economic, cultural, and social aspects of decision-making, not just the scientific ones assessed by EFSA. “The EU is relatively unique in the way that that happens, just because you have the 27 governments coming together.” One upshot, Roberts says, is that “particularly for producers, food safety alone does not guarantee you market access.”
So the EU procedure is lengthy for at least two reasons: member state involvement, and a focus on caution. “Comparing what is done in terms of food safety to other countries, it can become obvious that in some cases there are different priorities,” Ververis comments. He says that EFSA is strongly guided by the precautionary principle, whereas “in some other areas, maybe some other factors are taken more into consideration,” such as food security or food innovation.
Of course, political and traditional commercial interests also influence food safety processes outside the EU as well. In the U.S., “the FDA has faced considerable pressure from the meat and dairy industries, and their allies in Congress, to both slow the approval of novel proteins and restrict the terms used to describe these products,” according to Abhi Kumar, who leads grant-making on alternative protein at Open Philanthropy. “This is a mistake: novel food regulation should follow the science, not the politicians.”
The regulatory balance of speed and caution
Overall, Kumar believes, “This is a good process when it’s run efficiently and without political interference. But both EU and U.S. regulators are currently moving too slowly on approving novel proteins, which hurts innovation and climate progress.” He gives the example of Impossible Foods’ soy leghemoglobin (heme), whose application has been in progress for five years now.
The overall EU process for novel foods approval is estimated to take around 18 months on average. Again, there can be massive variation.
In general, there may be a trade-off between caution and innovation when it comes to alternative proteins – which have captured more attention (including criticism) than any other part of the plant-based world. It wasn’t until July 2024 that a company applied for approval of a cultivated meat product (a French cell-based foie gras) in the EU. This came following multiple submissions of cultivated meat in the U.K. and Switzerland, and approvals in Singapore and the U.S.
Roberts says that from GFI Europe’s point of view, “Until the summer, it certainly spoke volumes basically that the EU was a jurisdiction where there was not a submission, despite the fact that it has this huge population [and] lots of the most innovative cultivated meat companies are from the EU. It just seemed to be a bit anomalous until you kind of understood that there were regulatory consideration factors.”
Other regulators are also grappling with this trade-off. The U.K., where food regulators have had to deal with a heavier workload since leaving the EU’s centralized system, is now trying to bridge this in part with a funding boost of £1.6 million into Europe’s first regulatory sandbox for cultivated meat. Essentially, a sandbox is policy-wonk speak for a special one-off project that will give extra support to organizations innovating in a particular area. A regulator provides guidance but remains independent during this process. The U.K.’s new sandbox is planned to launch in February 2025 and run for two years. One goal is to reduce the high cost of going through an application to the U.K.’s Food Standards Agency (FSA) and Food Standards Scotland; according to the publication Green Queen, this cost runs between £350,000 and £500,000 per product.
There is already a similar sandbox in South Korea. And three years ago, “Singapore, which is a leader in novel proteins, launched its Future Ready Food Safety Hub (FRESH), a public-private partnership which helps food companies navigate regulatory pathways while boosting food safety,” comments Open Philanthropy’s Kumar.
“I think it’s important that the European Union also picks up on this and doesn’t fall behind in the way that they regulate,” Roberts says. He calls it a question of competitiveness and global attractiveness.
One thing that might help overall is more sharing of information across regions. The U.K’s FSA has signalled an interest in cooperating with some other regulators on approving novel foods already authorized in other regions. And Kumar notes that “Chinese and U.S. regulators are collaborating to share knowledge on the regulation of cultivated meat.”
Then there’s the possibility of cross-border effort on the producer side. Farmless, a Dutch microbial protein company, plans to submit the same safety dossier in the EU, the US, and Singapore simultaneously. There are challenges to such parallel applications. “I think the real solution would be the explicit harmonization of requirements across countries so that parallel applications become more feasible,” Kumar argues. He says that there is already some harmonization in Australia/New Zealand and six Middle Eastern countries. There has also been a global effort to align regulations through the Food and Agriculture Organization’s Codex Alimentarius.
Pepijn Vloemans, Farmless’ head of communications, voices a common concern: “the EU process takes very long, is drawn out and difficult to predict – there’s a lot of room for improvement.” There’s room for improvement in all food safety regulation systems, which are often several steps behind the level of innovation at private companies, not to mention under-resourced. The key will remain to improve without skimping on genuine safety concerns, without allowing any industry to regulate itself, and without getting mired in the politics slowing down climate action.
Reporting for this story was facilitated by a media trip organized by Business Finland. Business Finland has provided grant funding to Solar Foods.
