Navigating the regulatory maze of novel proteins

Argenta’s Mireia Romagosa Vilarnau on why patience, precision, and science-based rigor matter more than ever

Patience, not speed, is what shapes progress in food innovation. “In Spain we have a saying: patience is the mother of science,” says Mireia Romagosa Vilarnau. “My advice would be to prepare a good-quality dossier and not rush to submit.” For her, investing time early on is the surest way to prevent costly delays in the process.

That blend of pragmatism and rigor runs through her career. As Quality & Regulatory Affairs Manager at Argenta, Romagosa works on the frontline where innovation meets scrutiny, guiding companies through the European Union’s novel food system. From this vantage point, she sees clearly which technologies are gaining momentum, which submissions are stalling, and where the regulatory bottlenecks are most acute.

She confesses that the work can be demanding, but it is never monotonous. “Every product and manufacturing process is different. In the EU, the safety evaluation of novel foods is thorough and science-based. Requirements are evolving and becoming more strict, so you need to anticipate what authorities will ask for. The best part is that I learn a lot from every project.”

The alternative protein industry is moving quickly, with microbial, plant-based, and cell-cultivated approaches all vying for attention. “Statistically, we are recently receiving more requests for plant-based proteins, as well as microbial fermentation products,” says Romagosa. “Cell-based had an increased demand a couple of years ago, but over the past year that demand has fluctuated.”

Between 2022 and 2025, 18 out of 194 novel food dossiers submitted in the EU concerned alternative proteins. The largest share came from microbial sources, covering everything from freeze-dried mycelia to fermentation-derived proteins and microalgal biomass. Plant-based dossiers represented 22%, insects 11%, and cell-based just 5.6%.

“Microbial submissions are dominating right now,” Romagosa observes. “That shows where innovation energy is focused, even if approvals are not yet catching up.”

Consumer expectations are shaping the sector

If regulators provide the guardrails, consumers increasingly determine the route. “The consumer has a lot to say and directly influences the innovation of the alternative protein sector,” Romagosa believes. “But there is also resistance among consumers with more traditional consumption patterns and from the conventional protein industry.”

The Good Food Institute Europe’s 2024 survey of 10 countries underscores her point. While 62% of Europeans still identify as omnivores, 27% call themselves flexitarians. Even small percentages of vegetarians and vegans are reshaping the food landscape. Yet, over the past decade, meat supply in Europe has remained steady at around 77kg per person per year, with only modest shifts from red meat to poultry.

That tension between tradition and transition helps explain why novel proteins remain a relatively small share of the market despite significant consumer awareness. Still, Romagosa sees potential. “Alternative protein is yet a small segment of the total protein market in the EU, but it has a lot of room to grow,” she notes.

So far, the EU’s consolidated Union List of approved novel foods offers a snapshot of which protein sources have cleared the bar for commercialization. The list includes microbial ingredients like shiitake mycelial extract and dried Tetraselmis chuii algae, plant-based proteins such as potato and rapeseed, insect powders from crickets and mealworms, and even animal-derived proteins such as bovine lactoferrin.

Novel food dossiers need high investment, long evaluations, and the requirements are not always clear. Launching one novel food may take several years

Yet for all the microbial dossiers submitted in recent years, very few have secured approval. “Although microbial proteins make up a large proportion of applications,” Romagosa adds, “in the Union List of approved novel foods, we only see two proteins from microbial sources. In a couple of years, I expect to see a higher number.”

Whether the register is a leading or lagging indicator depends on perspective. “I believe it is an indicator, although there are other factors,” she explains. “The resources of the applicant, whether the ingredient is already used in other territories, how much safety data is available, whether the substance is well known, and the applicant’s capacity to prepare a good dossier all influence outcomes.”

Where companies stumble

Even promising ingredients can falter during the EFSA risk assessment process. Romagosa lists the most common pitfalls: not following EFSA guidance to the letter, incomplete dossiers, overreliance on confidentiality, and unexpected new requirements introduced during evaluation. Some challenges are particularly acute. “Identity is critical, especially for microbial sources,” she says. “Applicants need to provide whole genome sequencing with up-to-date bioinformatics analysis and properly address antimicrobial resistance, virulence factor genes, and secondary metabolites.”

Manufacturing processes must be described in detail, even when applicants are reluctant to disclose trade secrets. Compositional data often leads to additional requests for more parameters. Exposure assessments can be overestimated if applicants choose broad food categories, which in turn triggers stricter impurity thresholds. Toxicological requirements keep evolving, particularly for microorganisms, where both lysed cells and supernatants must now be tested in genotoxicity tests.

Then there is the growing focus on nanoparticles and allergenicity. “Applicants may find themselves having to repeat toxicity studies because of nanoparticle considerations,” she says. “And protein allergenicity must be properly assessed through its protein content, match similarity with known allergens, and literature search.”

Early engagement with authorities can help, but it has limits. Companies can request a formal consultation with a EU Member State to determine whether their ingredient qualifies as novel, a process that typically takes six to 18 months and results in a legally binding decision. With regards to Novel Food dossier preparatiom, EFSA’s pre-submission scientific advice is very limited and does not cover elements such as design of studies or acceptability of data generated.Nevertheless, “once the dossier is submitted and applicants receive clock stops, EFSA does allow clarification teleconferences,” Romagosa says. “But ideally, the regulatory landscape, including data requiremetns, should be clear from the very beginning of product development.”

Timelines that stretch into years

On paper, the EU process looks straightforward: one month for validation, nine months for EFSA risk assessment, and seven months for European Commission adoption, for a theoretical total of 18 months. In practice, it is far longer.

“During the 158^th Open Plenary of the EFSA NDA Panel, it was indicated that the average risk assessment lasts about 19 months with clock stops, and it could take up to five years,” she says. Complexity of the novel food, dossier quality, and new EFSA guidance are the main factors that drive variability.

Innovative or pioneering products take longest, sometimes exceeding five years, while more familiar substances with established safety data move more quickly. The Qualified Presumption of Safety (QPS) status of a microorganism can make a major difference. For companies preparing an application, Romagosa’s message is clear: do not underestimate the level of rigor. “Clients are the experts of their product. It is fundamental to properly address any potential hazard and prepare solid safety data. Strictly follow EFSA guidance and study similar dossier assessments.”

Organization and clarity also matter. “The way information is structured and how you anticipate EFSA requests can make a big difference,” she says.

Interestingly, she argues that food and feed dossiers are comparably demanding. “In the feed additive route you need to additionally demonstrate efficacy, so those dossiers are as exigent as novel food dossiers.” The real surprises, she adds, often come for companies outside the EU that are attempting their first application.

Regulation versus innovation

The biggest question is whether Europe’s regulatory system can keep pace with innovation. From Romagosa’s perspective, the gap remains significant. “From the industry perspective, the perception is that the evaluation process is too long. Novel food dossiers need high investment, long evaluations, and the requirements are not always clear in the guidance. Compared to other geographies, where approvals may take less than a year, the EU is slow.”

If she could change one thing, it would be the ability to engage EFSA earlier. “It would be very helpful to be able to engage EFSA prior to the start of studies, particularly for pioneer applications or complex ingredients.”

For innovators racing to launch the next generation of proteins, the regulatory process can feel like an obstacle course. Yet for Romagosa, that rigor is essential. Each dossier tells a story of safety, transparency, and trust.

“Every project teaches me something new,” she admits. “And every time, the key is the same: solid science, careful preparation, and a steady approach.”

It is a reminder that in the biorevolution, progress is not only measured in breakthroughs, but in the careful, deliberate steps that make those breakthroughs safe enough to reach the public.

For more information visit www.argentaglobal.com

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