Rhizomucor pusillus mycelium as a novel food: 44–68 g protein per 100 g and nine mycotoxin limits in the specification — from aflatoxins < 0.1 µg/kg to deoxynivalenol and nivalenol < 150 µg/kg
Commission Implementing Regulation (EU) 2026/1507, published on 6 July 2026, authorises from 26 July 2026 a powder of pasteurised, dried and milled biomass of the filamentous fungus Rhizomucor pusillus (strain CBS 143028) from The Protein Brewery B.V. — among others in cereal products, bars, dairy analogues, beverages and food supplements. The Commission replaced the name “fungal biomass” with “mycelium”, as the former could mislead consumers about its composition.
- Specification for control: moisture 4–7 g/100 g, crude protein (N × 6.25) 44–68 g/100 g, total fat 4–8 g/100 g, total dietary fibre 25–39 g/100 g, available carbohydrates ≤ 3 g/100 g, ash ≤ 6 g/100 g; arsenic, cadmium, lead and mercury each ≤ 0.1 mg/kg.
- Mycotoxins: aflatoxins (B1, B2, G1, G2) < 0.1 µg/kg, ochratoxin A < 1.0 µg/kg, T-2 and HT-2 toxins each < 7.5 µg/kg, zearalenone and diacetoxyscirpenol each < 20 µg/kg, fumonisins (B1, B2) < 100 µg/kg, deoxynivalenol and nivalenol each < 150 µg/kg. Microbiology: aerobic microorganisms ≤ 10³ CFU/g, B. cereus ≤ 100 CFU/g, coagulase-positive staphylococci ≤ 50 CFU/g, Enterobacteriaceae and E. coli each ≤ 10 CFU/g, Clostridium perfringens < 10 CFU/g, yeasts and moulds < 100 CFU/g, Listeria monocytogenes and Salmonella not detectable in 25 g.
- EFSA (NDA Panel opinion adopted on 29 September 2025): the 90-day study showed no effects of toxicological relevance up to the highest dose of 19 668 mg/kg bw per day; at the highest estimated intakes of 539–1013 mg/kg bw per day the margin of exposure is 37 for infants, 19 for young children, 26 for other children, 34 for adolescents and 31 for adults — considered sufficient by the Panel. The likelihood of triggering allergic reactions was considered low.
- Maximum levels: among others 30 g/100 g in breakfast cereals, 35 g/100 g in cereal bars, 20 g/100 g in dairy analogues (except beverages), 10 g/100 g in non-alcoholic beverages and biscuits; in meal replacement beverages for weight control at most 40 g per day in two meals, in food supplements 6 g per day with a warning for persons under 18 and pregnant and breastfeeding women. The applicant’s data are protected until 26 July 2031.