(fra kommisjonsforordningen)

(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 has established a Union list of novel foods. 

(3) On 2 August 2023, the company Effepharm (Shanghai) Ltd. (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place beta-nicotinamide mononucleotide (β-NMN) on the Union market as a novel food. The applicant requested the novel food to be used in food supplements as defined in Directive 2002/46/EC intended for the adult population, excluding pregnant and lactating women. 

(4) On 2 August 2023, the applicant also made a request to the Commission for the protection of the following proprietary data: identity of the novel food, compositional data, data on the history of use, Absorption, distribution, metabolism and excretion (ADME) and toxicological information. 

(5) On 11 April 2024, the Commission requested the European Food Safety Authority (ʽthe Authorityʼ) to provide a scientific opinion on beta-nicotinamide mononucleotide (β-NMN) as a novel food. 

(6) On 4 March 2026, the Authority adopted its scientific opinion on the ‘Safety of betanicotinamide mononucleotide (β-NMN) pursuant to Regulation (EU) 2015/2283 and the bioavailability of nicotinamide from this source in the context of Directive 2002/46/EC’, in accordance with Article 11 of Regulation (EU) 2015/2283. 

(7) In its scientific opinion, the Authority concluded that that the novel food, betanicotinamide mononucleotide (β-NMN), is safe under the proposed conditions of use. The Authority also concluded that the novel food is a source from which niacin is bioavailable. 

(8) In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the proprietary data concerning data on the identity of the novel food, certain compositional data10, certain data on Absorption, distribution, metabolism and excretion (ADME)11 and certain toxicological information12 , without which it could not have assessed the novel food and reached its conclusion. 

(9) The Commission requested the applicant to further clarify the justification provided with regard to its proprietary claim over those data and studies and to clarify their claim to an exclusive right of reference to them in accordance with Article 26(2), point (b), of Regulation (EU) 2015/2283. 

(10) The applicant declared that they held proprietary and exclusive rights of reference to the relevant studies at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data. 

(11) The Commission assessed all the information provided by the applicant and considers that they have sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, data on the identity of the novel food, certain compositional data, certain data on Absorption, distribution, metabolism and excretion (ADME), and certain toxicological information should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283. Accordingly, only the applicant should be authorised to place of beta-nicotinamide mononucleotide (β-NMN) on the market within the Union during a period of five years from the entry into force of this Regulation. 

(12) However, such restriction of the authorisation and the reference to the data contained in the applicant’s file for their sole use 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. 

(13) It is appropriate that the inclusion of beta-nicotinamide mononucleotide (β-NMN) 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) Beta-nicotinamide mononucleotide (β-NMN) 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,