Copenhagen – November 12, 2026 -- Danish biotech company 21st.BIO has filed an EU Novel Food application for BLG Essential+, its precision-fermentation process for bovine beta-lactoglobulin (BLG), and is lobbying Brussels for a fast-track approval route for comparable proteins. The filing follows US regulatory approval for sales, obtained in October 2025.
EFSA approval would open EU sales of fermentation-derived whey protein
BLG is the predominant protein in milk whey. 21st.BIO describes BLG Essential+ as essentially a copy of that protein, made by fermentation rather than by dairy production. The company says the process can complement conventional dairy supply and help address supply constraints in the European whey protein market, once the European Food Safety Authority (EFSA) approves it.
The company names muscle maintenance and recovery among the target uses. Its examples are elderly and sick people and users of weight-loss medication.
Company asks regulators for a clearer timetable on well-characterized proteins
21st.BIO says preparing the EU dossier took years of scientific and procedural work and significant investment. It argues that the uncertain approval process and timeline make it hard for manufacturers to plan investments, facilities and product launches in Europe.
It is calling for a fast-track pathway for nature-identical food proteins made with host strains and technologies that have a demonstrated record of safe use. CEO and co-founder Thomas G. Schmidt said, "This is not a choice between safety and speed."
Schmidt argues that approval would draw industrial investment into fermentation plants built in Europe. He says it would also create jobs and benefit European equipment makers and process-design companies.
Aspergillus oryzae strain lineage underpins the safety case
BLG Essential+ is produced with Aspergillus oryzae, a microorganism used for centuries in Japanese soy sauce and miso fermentation. Novonesis developed and refined the production platform over decades, and 21st.BIO has developed it further.
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. The study documented the absence of the known mycotoxin biosynthesis pathways it covered and the inactivation of the penicillin G gene cluster.
José Arnau, 21st.BIO's Chief of Strain Engineering and Regulatory Affairs and a co-author of the study, said advanced genome analyses let regulators assess safety at strain level with greater precision. He said regulatory requirements for proven platforms making nature-identical proteins should be lower, with a more straightforward and faster evaluation.