21st.BIO seeks EU clearance for milk protein and faster route to market

21st.BIO has filed an EU Novel Food application for its precision-fermented milk protein BLG Essential+, while calling for a faster regulatory pathway to help European biotechnology companies establish production and sell their ingredients closer to home.

• 21st.BIO has filed an EU Novel Food application for BLG Essential+.
• The company wants faster, predictable approvals for proteins made using established production platforms.
• European authorization could support investment in regional protein production.

The Danish industrial biotechnology company announced the filing on November 12, following what it described as US regulatory approval for sales in October 2025. Its application concerns bovine beta-lactoglobulin, or BLG, the predominant protein in whey, produced using precision fermentation.

The business develops technology intended to enable low-cost, large-scale protein production. It said European access to that technology could help strengthen regional protein supply while using fewer resources, alongside existing sources of dairy-derived whey protein.

Alongside the submission, 21st.BIO argued that Europe needs a more predictable route to market for well-characterized proteins that match those found in nature and are manufactured using production platforms with an established safety record.

“Europe has the science, the companies and the industrial heritage in precision fermentation to lead the wave of healthy and nutritious food production,” said Thomas G. Schmidt, Co-founder & CEO of 21st.BIO.

“What Europe still needs is a home market that allows industrially proven technology to move from laboratories into fermentation factories built in Europe. A predictable, science-based route to market can strengthen food resilience, attract industrial investment and ensure that European innovation is commercialized in Europe.”

BLG is valued for its amino acid profile and functionality in food formulations. 21st.BIO said its fermentation technology could complement conventional dairy production and help address supply constraints in the European whey protein market.

The company identified nutritional support for older adults and people recovering from illness among the potential applications. It also highlighted people taking weight-loss medication who want to maintain muscle, alongside demand for compact, protein-rich nutrition.

Those applications form part of its case for expanding access to high-quality protein through fermentation. The company said the technology could provide scalable production and consistent costs in regions where the ingredient is authorized for manufacture and sale.

The EU filing does not itself authorize sales. In its announcement, 21st.BIO linked the prospect of European market access to investment decisions about production facilities, equipment and staffing.

The company said preparing its dossier had required years of scientific and procedural work and significant investment. Uncertainty over the subsequent approval process and its duration made it difficult for innovators and manufacturers to plan facilities and product launches, it added.

21st.BIO is seeking a fast-track pathway for nature-identical food proteins made using host strains and technologies with a demonstrated record of safe use. It said such a route should maintain European safety standards while giving applicants and potential commercial partners a clearer timetable.

“This is not a choice between safety and speed,” Schmidt added. “It is an opportunity to apply the best science to achieve both. Europe can protect consumers, offer healthy and nutritious food options to Europeans, and offer nutritional self-sufficiency, industrial production, skilled jobs and sustained technology leadership.”

The company pointed to Europe's existing biotechnology capabilities, including those developed by Novonesis, as a foundation for further food protein production. It said authorization could support investment in European factories and employment for scientists, operators, technicians and skilled workers, as well as demand for equipment and process-design services.

BLG Essential+ is produced using Aspergillus oryzae, a microorganism with a long history in Japanese food fermentation, including soy sauce and miso. According to 21st.BIO, its production platform builds on decades of development by Novonesis and further work by its own team.

The company cited a 2025 peer-reviewed study in Applied Microbiology and Biotechnology describing the strain lineage as the first mycotoxin-free A. oryzae lineage for industrial production of alternative and novel proteins.

The study documented the absence of the known mycotoxin biosynthesis pathways it examined and the inactivation of the penicillin G gene cluster. These findings concern the production strain, which is central to the company's argument for a more targeted safety assessment.

“This is a well-characterized production platform with consumer safety designed into the strain,” said José Arnau, Chief of Strain Engineering & Regulatory Affairs at 21st.BIO and a co-author of the study.

“Advanced genome analyses allow regulators to assess safety at strain level with far greater precision, and for proven platforms producing proteins that match those found in nature, the regulatory requirements should be lower and the safety evaluation more straightforward... and faster.”

(Main picture shows Thomas G. Schmidt, Co-founder & CEO of 21st.BIO, who is calling for a more predictable EU approval process to support investment in European protein production)

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