1. Rhizomucor pusillus mycelium is authorised to be placed on the market within the Union.
Rhizomucor pusillus mycelium shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company The Protein Brewery B.V. ( 16 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 26 July 2026, unless a subsequent applicant obtains an authorisation for the novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the company The Protein Brewery B.V.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the company The Protein Brewery B.V.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEXSupplementary provisions
ANNEX
The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
(1)
in Table 1 (Authorised novel foods) the following entry is inserted in alphabetical order:
Authorised novel food
Conditions under which the novel food may be used
Additional specific labelling requirements
Other requirements
Data protection
‘
Rhizomucor pusillus mycelium
Specified food category
Maximum levels
The designation of the novel food on the labelling of the foodstuffs containing it shall be “ Rhizomucor pusillus mycelium”.
The labelling of food supplements containing “ Rhizomucor pusillus mycelium” shall bear a statement that they should not be consumed by persons under 18 years of age, and pregnant and lactating women.
Authorised on 26 July 2026. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
Applicant: “The Protein Brewery B.V.”, Goeseelsstraat 10, 4817 MV, Breda, Netherlands.
During the period of data protection, the novel food Rhizomucor pusillus mycelium is authorised for placing on the market within the Union only by “The Protein Brewery B.V.” unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of “The Protein Brewery B.V.”.
End date of the data protection: 26 July 2031.’
Rhizomucor pusillus mycelium powder
Breakfast cereals, and cereal-, fruit- or vegetable-based snacks
30 g/100 g
Biscuits
10 g/100 g
Cereal bars
35 g/100 g
Dairy analogues except drinks
20 g/100 g
Non-alcoholic beverages
10 g/100 g
Flatbread and steamed breads
20 g/100 g
Chocolate confectionery
15 g/100 g
Cocoa-based spreads
20 g/100 g
Meal replacements for weight control for the adult population (as drinks)
Maximum 2 meals/day up to a maximum of 40 g/day
Food supplements as defined in Directive 2002/46/EC, for the general adult population, excluding pregnant and lactating women
6 g/day
(2)
in Table 2 (Specifications), the following entry is inserted in alphabetical order:
Authorised novel food
Specification
‘
Rhizomucor pusillus mycelium
Description:
The novel food is the biomass of the fungus Rhizomucor pusillus (strain CBS 143028), which has been produced via fermentation. The biomass is then harvested, pasteurised to inactivate the viable fungus cells, dried and milled into a whitish odourless powder. Rhizomucor pusillus is a filamentous fungus belonging to the Mucoraceae family.
Characteristics/Composition:
Moisture: 4-7 g/100 g
Crude protein content (N × 6,25): 44-68 g/100 g
Total fat content: 4-8 g/100 g
Total dietary fibre: 25-39 g/100 g
Total digestible carbohydrates: ≤ 3 g/100 g
Ash: ≤ 6 g/100 g
Microbiological criteria:
Total aerobic microbial count: ≤ 10 3 CFU (*)/g
Bacillus cereus : ≤ 100 CFU/g
Clostridium perfringens : < 10 CFU/g
Coagulase-positive staphylococci: ≤ 50 CFU/g
Enterobacteriaceae: ≤ 10 CFU/g
Escherichia coli : ≤ 10 CFU/g
Listeria monocytogenes: Not detected in 25 g
Salmonella spp.: Not detected in 25 g
Yeasts and moulds: < 100 CFU/g
(*)
CFU = Colony Forming Units
Heavy metals:
Arsenic (As): ≤ 0,1 mg/kg
Cadmium (Cd): ≤ 0,1 mg/kg
Lead (Pb): ≤ 0,1 mg/kg
Mercury (Hg): ≤ 0,1 mg/kg
Mycotoxins:
Aflatoxins (B1, B2, G1, G2): < 0,1 μg/kg
Diacetoxyscirpenol: < 20 μg/kg
Fumonisins (B1, B2): < 100 μg/kg
HT2 Toxin: < 7,5 μg/kg
T2 Toxin: < 7,5 μg/kg
Nivalenol: < 150 μg/kg
Ochratoxin A: < 1,0 μg/kg
Deoxynivalenol (DON): < 150 μg/kg
Zearalenone: < 20 μg/kg’