21st.Bio seeks EU fast-track for animal-free whey protein

21st.Bio has submitted an EU regulatory application for its recombinant beta-lactoglobulin protein, BLG+ Essential, in 2024. The company, which secured US clearance two years prior, is pushing for a fast-track approval route amid a dairy supply crisis. Whey prices have increased fivefold over the last year, hitting all-time highs in the US and Europe. Global dairy output is projected to fall short by 31 million tonnes of milk equivalents by the end of the decade. The company argues the EU’s notoriously slow and expensive novel food process is a bottleneck for food security and commercial investment.

Scientific advantages and regulatory strategy

The precision fermentation process uses a specially engineered strain of Aspergillus oryzae, the koji mould used historically for soy sauce and miso. This lineage is the first mycotoxin-free Aspergillus oryzae developed for industrial protein production, a fact confirmed in a 2025 peer-reviewed paper. The study confirmed the strains lack known mycotoxin biosynthesis pathways. 21st.Bio first announced these findings in April 2025, arguing the well-characterized, safe platform should speed up European approvals. The EU application specifically requests a faster pathway for nature-identical proteins made using host strains with a record of safe use. The company obtained self-affirmed GRAS status for the ingredient in the US in September 2024. The production platform was developed over decades by the Danish biosolutions company Novonesis, which licenses part of it to 21st.Bio.

José Arnau, Chief of Strain Engineering and Regulatory Affairs at 21st.Bio, stated that having safety designed into the strain allows for a more precise and faster regulatory assessment. The company proposes a pathway that maintains safety standards while providing a clearer approval timetable. The dossier itself represented years of scientific work and considerable investment.

Investment and market opportunity

Novo Holdings invested €86 million in 21st.Bio in 2021. The company contends that EU approval would unlock investment in fermentation plants across Europe, creating jobs for scientists, operators, and technicians. It would also generate work for equipment manufacturers and process-design firms. CEO Thomas G. Schmidt argued that Europe has the science and industrial heritage to lead in precision fermentation but needs a reliable home market to move technology from labs to factories. A predictable, science-based route to market can strengthen food resilience and attract industrial investment, he added.

The primary market targets are high-protein applications for specific nutritional needs. These include older adults and ill people needing muscle support, individuals on weight-loss medication aiming to preserve muscle mass, compact nutrition for people on the go, and nutrition in conflict zones.

Competitive landscape and commercial implications

21st.Bio is among several startups producing precision-fermented beta-lactoglobulin. Competitors like Perfect Day, Remilk, Imagindairy, Vivici, and Verley are all cleared to sell in the US but not yet approved in the EU. An EU authorization would allow 21st.Bio's partners to exclusively produce and sell BLG Essential+ in Europe. The company operates on a licensing model, providing partners with production strains, processes, pilot production, and regulatory support for them to manufacture the protein themselves.

The protein itself, beta-lactoglobulin, comprises 65% of dairy whey content. It has 45% more leucine than commercially available whey protein isolates. 21st.Bio is also developing alpha-lactalbumin, another whey protein. The company serves as an end-to-end partner for bioindustrial companies, scaling innovations for sectors including food and drink, sweet proteins, and biomaterials. The lengthy and uncertain EU approval process makes it difficult for producers to plan facilities and product launches. EU regulatory approval for BLG+ Essential+ is the final step needed to enable European production and sale of this animal-free whey protein.