Copenhagen fermentation firm seeks EU route for cow-free whey protein

21st.Bio has filed an EU dossier for its precision-fermented BLG and wants regulators to speed up authorisation as whey prices hit records.

21st.Bio, a Copenhagen-based precision fermentation company, has filed a regulatory dossier for EU approval of its recombinant beta-lactoglobulin (BLG) product, BLG+ Essential. The company is also asking the European Food Safety Authority to fast-track authorisation for well-characterised, nature-identical proteins made with host strains and technologies that have a proven safety record. It received clearance to sell the protein in the US two years ago.

The protein is produced with Aspergillus oryzae, a koji mould. BLG makes up 65% of dairy whey content, and the company says its version contains 45% more leucine than commercial whey protein isolates. A peer-reviewed study from last year described the strain lineage as the first mycotoxin-free A. oryzae lineage for industrial production of novel proteins, with the penicillin G cluster inactivated. The firm, founded in 2020 by Thomas G Schmidt and Per Falholt, licenses part of its technology from Novonesis and was backed with €86M from Novo Holdings in 2021. It is also working on alpha-lactalbumin, another whey protein.

The case for abundance is about supply. Whey prices have reportedly reached record highs in the US and Europe, up fivefold over the past year, and global dairy output is projected to fall 31 million tonnes of milk equivalents short by the end of the decade. Neither figure comes with a named source. The company points to ageing populations and GLP-1 users as drivers of protein demand. A protein made by fermentation rather than cows could widen supply and, if costs fall, make protein cheaper. Perfect Day, Remilk, Imagindairy, Vivici and Verley are cleared in the US but not yet in the EU.

Watch for whether EFSA agrees to any faster pathway. It has not, and no decision date has been given. The company's claims on speed versus safety, climate footprint and BLG's muscle and metabolic benefits come from the company or unnamed scientists, not independent verification.

Source: Green Queen