The PLANTOMYC project continues to advance on the path to developing innovative hybrid meat analogues that combine plant-based ingredients with mycelial protein biomass (MPB). As part of this effort, our partner ATOVA has successfully completed Deliverable D1.1: EU Regulatory Analysis for Strains and Substrates, marking a significant milestone for the project.

This comprehensive analysis focused on assessing the novel food status under EU law of a preliminary list of more than 30 fungal species proposed for MPB production, as well as the fermentation processes and the different (co-)substrates involved. ATOVA developed a tailored regulatory methodology, drawing on existing EU references and precedents, to provide clear guidance for the PLANTOMYC consortium.

The team designed a decision tree to help systematically classify the regulatory status of each fungal species evaluated. The results of this analysis showed that:

– 3 fungal species were categorised as not novel.
– 4 species were assessed as likely not novel.
– 15 species were considered novel.
– 1 species with strain-dependent status.
– 10 with unclear status requiring further consultation

Importantly, the novel food status of the MPB is primarily determined by the fungal species employed. However, substrates can also influence the regulatory pathway, especially if they are considered novel and remain present in the final MPB product. For instance, substrates such as brewers’ spent grain (BSG) and starch-rich pea protein by-products are likely not novel, owing to their established history of consumption in the EU prior to 1997. Conversely, ingredients like thin silage may require additional regulatory clarification before use.

The analysis also confirmed that fermentation itself does not automatically classify a food as novel. If a non-novel fungal species is used and no significant changes occur in the nutritional composition, metabolism, or the levels of undesirable substances in the food, the product may not fall under the novel food definition.

These findings represent an essential step in paving the way for PLANTOMYC’s innovative products. Moving forward, the project will leverage these insights to plan potential novel food consultations under Article 4 of Regulation (EU) No. 2015/2283 with relevant EU authorities. Such consultations will help resolve any remaining regulatory uncertainties and ensure that PLANTOMYC’s hybrid meat analogues can reach the market safely and in full compliance with EU food laws.