21st.BIO Files EU Novel Food Application for Animal-Free BLG and Calls for a Fast-Track Approval Route

Danish precision fermentation company 21st.BIO has filed an EU Novel Food application for its BLG Essential+, a beta-lactoglobulin (BLG) protein derived from Aspergillus oryzae, aiming for a faster regulatory approval route for well-characterized, nature-identical proteins. The company emphasizes that advancements in genome analysis can enhance safety assessments and streamline the approval process, which is currently lengthy and hinders production planning. With this development, 21st.BIO hopes to spur investments in fermentation facilities across Europe, generating jobs and fostering innovation in the food sector.

The proposed BLG Essential+ targets high-protein applications for specific demographics, including the elderly and individuals undergoing weight-loss treatment. CEO Thomas G. Schmidt advocates for a predictable regulatory pathway that maintains safety standards while facilitating the transition from laboratory research to commercial production in Europe. He believes that this approach will bolster food security, stimulate industrial investment, and enhance Europe’s position as a leader in precision fermentation and innovative food production technologies.