The European Commission’s call for evidence on its proposed Biotech Act II has drawn responses from across the alternative protein and industrial biotech sectors, with companies urging clearer regulatory pathways for fermentation-derived ingredients, cultivated biomass, and precision fermentation ahead of the June 10 deadline.
The regulation, expected as a legislative proposal in Q4 2026, would extend the EU’s biotech framework beyond health biotechnology to cover industrial biotechnology and biomanufacturing. The Commission has cited regulatory fragmentation, weak price competitiveness against fossil-based incumbents, and pressure from the US and China as the primary problems requiring intervention.
Fermentation and novel protein companies push for inclusion
The Protein Brewery, a Netherlands-based fungal biomass fermentation company, submitted feedback calling on the Commission to ensure that microbial advanced fermentation technologies are explicitly included in the act’s scope and treated as a strategic priority.
Beyond the structural issues flagged by the Commission, the company identified additional barriers specific to novel microbial proteins: labelling requirements that rely on unclear Latin nomenclature, overly conservative food category restrictions, and safety assessment frameworks it described as unsuitable for this product category.
The Protein Brewery also questioned whether novel food status should be permanent, asking whether a product could transition to conventional ingredient status over time once sufficient safety data exists.
Estonia-based ÄIO, which uses yeast fermentation to produce lipids as alternatives to animal and tropical fats, called for “clear, harmonised frameworks that support the transition towards high-value, circular bio-based production, including the use of waste-derived and CO-based feedstocks,” adding that “robust sustainability criteria, traceability, and fair market conditions for EU and imported products will be critical to ensure environmental integrity and global leadership.”
Cultivated cell companies flag regulatory grey zones
Czech cultivated biomass developer Bene Meat Technologies used its submission to press for explicit coverage of non-microbial biomanufacturing applications, including cultivated animal cells and cellular agriculture. The company warned that without clear treatment of organisms developed through new genomic techniques, including CRISPR-based methods, companies in the cultivated sector risk being left in “regulatory grey zones or fragmented across disconnected sectoral regimes.”
Bene Meat encouraged the Commission to align the risk-based logic of Biotech Act I with the architecture of Biotech Act II and to ensure consistent treatment of genetic modification techniques across plant, microbial, and animal applications.
Broader competitiveness concerns
Swiss biosolutions company Novonesis framed the stakes at a broader level, warning that without an enabling framework, “Europe remains a strong innovation hub while value creation and large-scale deployment increasingly take place in other regions.”
