(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)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes nicotinamide riboside chloride as an authorised novel food.

(4)

Commission Implementing Regulation (EU) 2020/16 (3) authorised the placing on the market of nicotinamide riboside chloride as a novel food for use in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), for the adult population.

(5)

On 2 March 2020, the company ChromaDex Inc. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food nicotinamide riboside chloride. The applicant requested to extend the use of nicotinamide riboside chloride to: foods for special medical purposes and total diet replacement for weight control, as defined by Regulation (EU) No 609/2013 of the European Parliament and of the Council (5), at 500 mg per day, and meal replacements, at 300 mg per day; all of those categories intended for the adult population, excluding pregnant and lactating women.

(6)

On 2 March 2020, the applicant also made a request to the Commission for the protection of proprietary data for a study submitted in support of the application, namely, a human study evaluating the safety and dose-dependent effects of nicotinamide riboside chloride supplementation (6).

(7)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 8 June 2020, requesting it to provide a scientific opinion by carrying out an assessment of an extension of use of the novel food nicotinamide riboside chloride.

(8)

On 14 September 2021, the Authority adopted its scientific opinion on the ‘Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283’ (7) in accordance with Article 11 of Regulation (EU) 2015/2283.

(9)

In its scientific opinion, the Authority concluded that nicotinamide riboside chloride, when used at levels of 500 mg per day in foods for special medical purposes and in total diet replacement for weight control intended for the adult population, excluding pregnant and lactating women, is safe. Therefore, it is appropriate to change the conditions of use of nicotinamide riboside chloride and to authorise use of nicotinamide riboside chloride in those foods.

(10)

In the same opinion, the Authority assessed the safety of meal replacements for the general population, and not only for adults, as according to Article 5(6) of Commission Implementing Regulation (EU) 2017/2469 (8) it cannot be excluded that meal replacements containing the novel food would be consumed by other groups of the population. In its opinion, the Authority also indicated that, with the exception of infants, the intake of 300 mg per day of nicotinamide riboside chloride from meal replacements for the adult population, excluding pregnant and lactating women, would be below the established nicotinamide Upper Level (9) (‘UL’) and thus would be considered to be safe. However, in light of the assessment of the Authority on the use of the novel food in meal replacements for all population groups, except infants, demonstrating that the intake of the novel food from meal replacements will be well below the UL for nicotinamide, and in light of the fact that meal replacements are a category of food that is essentially exclusively sought after and used by adults, the Commission is of the view that the novel food may be authorised only for use in meal replacements for the adult population, excluding pregnant and lactating women, at the use level of 300 mg day, as proposed by the applicant.

(11)

That scientific opinion gives sufficient grounds to establish that nicotinamide riboside chloride, when used at levels of 500 mg per day in foods for special medical purposes and total diet replacement for weight control intended for the adult population, excluding pregnant and lactating women fulfils the conditions for its placing on the market in accordance with Articles 9 and 12(1) of Regulation (EU) 2015/2283. Furthermore, that scientific opinion also gives sufficient grounds to establish that nicotinamide riboside chloride, when used at levels of 300 mg per day in meal replacements intended for the 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.

(12)

Safety data and assessment of nicotinamide riboside chloride for use in foods for special medical purposes, total diet replacement for weight control and meal replacements covered only the adult population, excluding pregnant and lactating women. Therefore, a labelling requirement should be provided in order to properly inform the consumers that foods for special medical purposes, total diet replacement for weight control and meal replacements containing nicotinamide riboside chloride should only be consumed by persons above 18 years of age excluding pregnant and lactating women.

(13)

In its scientific opinion, the Authority included maximum levels for mercury, cadmium and lead in the specifications of the novel food. These levels are applicable only to foods for special medical purposes, total diet replacement for weight control and meal replacements as for these foods no maximum levels for mercury, cadmium and lead have been established by Commission Regulation (EC) No 1881/2006 (10). Therefore, the specification of the novel food should be amended accordingly by setting up maximum levels for these heavy metals applicable only to new uses. As no maximum level have been set for arsenic by the same Regulation, the level set by the present Regulation shall be applicable to all authorised uses.

(14)

In its scientific opinion, the Authority indicated that the human study evaluating the safety and dose-dependent effects of nicotinamide riboside chloride supplementation (11) was not needed for the assessment and reaching the conclusion by the Authority. Therefore, that study should not be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

(15)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(16)

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