Alternative Protein Sector Calls for Clear EU Biotech Law II Frameworks

The European Commission’s call for comments on its draft Biotech Law II has prompted reactions from the alternative protein and industrial biotech sectors. Ahead of the June 10th deadline, companies called for clearer regulatory pathways for fermented ingredients, cultured biomass, and precision fermentation.

The regulation, expected to be presented as a legislative proposal in the fourth quarter of 2026, would extend the EU legal framework for biotech beyond health biotech to include industrial biotechnology and biological manufacturing. The Commission has identified the fragmentation of legislation, weak price competitiveness vis-à-vis established fossil-fuel-based technology providers, and pressure from the US and China as the main issues requiring intervention.

Companies in the fields of fermentation and novel proteins are advocating for inclusion in teh Biotech Law

The Protein Brewery, a Netherlands-based company involved in the fermentation of fungal biomass, submitted an opinion urging the Commission to ensure that advanced microbial fermentation technologies are explicitly included in the scope of the law and treated as a strategic priority.

Beyond the structural problems identified by the Commission, the biotech company has identified further obstacles specific to novel microbial proteins: labelling requirements based on an unclear Latin nomenclature, overly restrictive limitations on food categories, and safety assessment frameworks which it deemed unsuitable for this product category.

Protein Brewery also raised the question of whether the novel food status should be permanent and wanted to know if a product could eventually be reclassified as a conventional ingredient once sufficient safety data is available.

The Estonian company ÄIO, which produces lipids as an alternative to animal and tropical fats using yeast fermentation, called for “clear, harmonized frameworks that support the transition to high-quality, circular, bio-based production, including the use of waste-derived and CO-based feedstocks,” adding that “sound sustainability criteria, traceability, and fair market conditions for EU and imported products will be crucial to ensuring environmental integrity and global leadership.”

Companies point to regulatory grey areas

In its statement, Czech developer of cultured biomass, Bene Meat Technologies, urges explicit consideration of non-microbial applications of biomanufacturing, including cultured animal cells and cellular agriculture. The company warned that without clear regulations for organisms developed using new genome techniques, including CRISPR-based methods, companies in the cultured biomass sector risk remaining in “regulatory gray areas or being split across different, unlinked sectoral sets of rules.”

Bene Meat called on the Commission to adapt the risk-based logic of Biotech Act I to the structure of Biotech Act II and to ensure a uniform treatment of genetic engineering techniques in plant, microbial and animal applications.

Concerns regarding the competitiveness of the EU

The Danish biotech company Novonesis put the situation into a broader context, warning that without appropriate framework conditions, Europe “will remain a strong innovation hub, but value creation and large-scale deployment will increasingly take place in other regions.”

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(Featured image by Guillaume Perigois via Unsplash)

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