(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

On 16 May 2020, the company The Protein Brewery B.V. (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place Rhizomucor pusillus fungus biomass on the Union market as a novel food. The applicant requested the Rhizomucor pusillus fungus biomass to be used as a whole food, as an ingredient in several food products, including meal replacement for weight control at levels not exceeding 40 g per meal, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (3), at levels not exceeding 6 g/day for the general adult population, excluding pregnant and lactating women.

(4)

On 16 May 2020, the applicant also made a request to the Commission for the protection of the proprietary scientific studies and data, namely, identity of the novel food (4), production process (5), compositional analysis (6), history of use (7), absorption, distribution, metabolism and excretion information (8), nutritional information (9), toxicological information (10), genotoxicity (11), subchronic toxicity study (12), human data (13), and allergenicity (14).

(5)

On 7 January 2021, the Commission, requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of Rhizomucor pusillus fungus biomass as a novel food.

(6)

On 29 September 2025, the Authority adopted its scientific opinion ‘Safety of Rhizomucor pusillus biomass powder as a novel food pursuant to Regulation (EU) 2015/2283’ (15) in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its scientific opinion, the Authority concluded that Rhizomucor pusillus fungus biomass is safe under the proposed conditions of use for the proposed target population. Therefore, that scientific opinion gives sufficient grounds to establish that Rhizomucor pusillus fungus biomass, when used as a whole food, as an ingredient in food products, including, meal replacement for weight control at levels not exceeding 40 g per meal, and in food supplements at levels not exceeding 6 g/day for the general adult population, excluding pregnant and lactating women, fulfils the conditions for its placing on the market in accordance with Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on analytical reports for the identity of the novel food, production process, compositional analysis, history of use, absorption, distribution, metabolism and excretion information, nutritional information, toxicological information, genotoxicity, subchronic toxicity study, human data, and allergenicity, without which it could not have assessed the novel food and reached its conclusion.

(9)

The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data at the time they submitted the application.

(10)

The Commission assessed all the information provided by the applicant and considered that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the scientific evidence and data, namely, identity of the novel food, production process, compositional analysis, history of use, absorption, distribution, metabolism and excretion information, nutritional information, toxicological information, genotoxicity, subchronic toxicity study, human data, and allergenicity should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place Rhizomucor pusillus fungus biomass on the market within the Union during a period of five years from the entry into force of this Regulation.

(11)

However, restricting the authorisation of Rhizomucor pusillus fungus biomass and the reference to the scientific evidence and data contained in the applicant’s file for the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.

(12)

The use of the term ‘Rhizomucor pusillus fungus biomass’ in the designation of the novel food could mislead consumers as to its identity and composition. Therefore, it is appropriate to replace the term ‘Rhizomucor pusillus fungus biomass’ with the designation ‘Rhizomucor pusillus mycelium’ proposed by the applicant.

(13)

It is appropriate that the inclusion of Rhizomucor pusillus mycelium as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.

(14)

Rhizomucor pusillus mycelium should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,