21st.BIO files EU Novel Food application for BLG Essential+™ and calls for a European home market for industrially proven precision fermentation technology for production of food

21st.BIOs Novel Food application for the milk protein beta-lactoglobulin (BLG), marks a significant step toward producing high-quality proteins in Europe with fewer resources while helping address supply constraints in the European whey protein market. When approved by EFSA, 21st.BIO's BLG Essential+ can enable resource-efficient milk protein production and sale in Europe using industrially proven precision fermentation technology. This highlights the need for a predictable, fast-track EU approval process for well-characterized, nature-identical food proteins produced using technologies with a demonstrated safety record.

COPENHAGEN, Denmark, Nov. 12, 2026 /PRNewswire/ -- 21st.BIO, a Danish industrial biotechnology company enabling low-cost, large-scale production of high-quality protein through precision fermentation, filed an EU Novel Food application for BLG Essential+™, its production technology for bovine BLG. The filing follows regulatory approval for sales in the US, obtained in October 2025. The company now offers the same technology to the European market.

Precision fermentation is an enabling technology for producing nutritious food ingredients, materials, and agricultural solutions. Denmark and Europe are already regions of excellence for precision fermentation, with innovation and industrial capabilities built over decades.

"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 and 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: The protein that can feed the world, and take us to Mars

BLG (Beta-lactoglobulin) is the predominant protein in whey protein from milk, valued for its high-quality amino-acid profile and versatile functionality. BLG Essential+™ is 21st.BIO's beta-lactoglobulin and is essentially a copy of the best protein in milk produced through precision fermentation. 21st.BIOs fermentation technology enables consistent cost offering, scalable protein production that can complement conventional dairy supply and strengthen regional protein supply wherever it is approved for production and sale.

Demand for high-quality protein is soaring, with BLG at the top for nutrition. BLG is the protein you would want to offer to elderly and sick people who need nutritional support for muscle maintenance, building and recovery, as well as people on weight-loss medication seeking to maintain and build muscle while losing fat. It is also ideally suited for compact nutrition; for people on the go, in conflict zones or, maybe even travelling to Mars.

Europe's strategic opportunity

Europe is already a region of excellence for precision fermentation, with industrial capabilities built over decades by companies such as Novonesis, and a strong science base across Denmark and the wider EU.

Approval of this technology can unlock significant investment and enable establishment of industrial production facilities across Europe, creating jobs for scientists, operators, technicians and skilled workers, while strengthening European equipment manufacturers, process-design companies and scientific leadership.

Preparing a full EU dossier has required years of scientific and procedural work and significant investment from 21st.BIO, while subsequent approval process and timeline make it tough for innovators and manufacturers to plan investments, facilities and launch products in Europe.

The ask to European regulators

21st.BIO is therefore calling for a fast-track pathway for well-characterized, nature-identical food proteins produced using host strains and technologies with a demonstrated record of safe use. Such a pathway should preserve Europe's high safety standards providing applicants and market developers with 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."

A technology rooted in European industrial biotechnology

BLG Essential+™ is produced using Aspergillus oryzae, a microorganism used for centuries in Japanese food fermentation, including soy sauce and miso. The production platform has been developed and refined over decades by Novonesis and further advanced by 21st.BIO for safe, efficient food protein production at massive scale.

A 2025 peer-reviewed study in Applied Microbiology and Biotechnology described the strain lineage as the first mycotoxin-free A. oryzae lineage for industrial production of alternative and novel proteins, documenting the absence of the known mycotoxin biosynthesis pathways covered by the study and the inactivation of the penicillin G gene cluster.

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

CONTACT:

Media contact:

Barbara Taudorf Andersen
SVP, Commercial Development and Strategic Partnerships
[email protected] | +45 21 56 18 43
www.21st.bio
 

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