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Commission Implementing Regulation (EU) 2026/1507 of 3 July 2026 authorising the placing on the market of Rhizomucor pusillus mycelium as a novel food and amending Implementing Regulation (EU) 2017/2470

Commission Implementing Regulation (EU) 2026/1507 of 3 July 2026 authorising the placing on the market of Rhizomucor pusillus mycelium as a novel food and amending Implementing Regulation (EU) 2017/2470

Implementing Regulation (EU) 2026/1507 · Regulation · 5 articles

Data as of 2026-07-30 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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.

Article 2

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.

Article 3

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.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Supplementary provisions

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’

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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