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

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018, shall be treated as an application submitted under Regulation (EU) 2015/2283.

While the request for placing 1-methylnicotinamide chloride on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

On 26 November 2015, the competent authority of the United Kingdom issued its initial assessment report. In that report, it came to the conclusion that 1-methylnicotinamide chloride meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

On 11 December 2015, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to the safety and tolerance of 1-methylnicotinamide chloride, and in particular on the effects on consumer health of the long-term intake of 1-MNA, especially when taking into account the intake of niacin from the diet, including food supplements.

In view of the objections raised by the other Member States, on 11 August 2016, the Commission consulted the European Food Safety Authority (‘the Authority’) asking it to carry out an additional assessment for 1-methylnicotinamide chloride as novel food ingredient in accordance with Regulation (EC) No 258/97

That opinion gives sufficient grounds to establish that 1-methylnicotinamide chloride in the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

On 18 February 2018, the Authority considered that in elaborating its opinion on 1-methylnicotinamide chloride as a novel food, the methods of analysis served as the basis to assess the specifications and the composition of 1-methynicotinamide, the in vitro micronucleus test study with human lymphocytes served as the basis to conclude that there were no concerns with respect to the genotoxicity of 1-methylnicotinamide chloride, and the 90-day oral toxicity study served as the basis to establish a reference point and to assess whether the margin of exposure in relation to the proposed maximum intake of 1-methylnicotinamide chloride by humans is sufficient.

Following the receipt of the Authority's opinion, the Commission requested the Applicant to further clarify the justification provided with regard to their proprietary claim over the studies, which were unpublished at the time the application was submitted, and to clarify their claim to an exclusive right of reference to those studies, as referred to in Article 26(2)(a)(b) of Regulation (EU) 2015/2283.

The Applicant has also declared that, at the time the application was submitted, they held proprietary or exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies. The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.

Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the methods of analysis of 1-methylnicotinamide chloride, the in vitro micronucleus test with human lymphocytes study, and the 90-day sub chronic oral toxicity study contained in the Applicant's file should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the Applicant for a period of five years.

However, restricting the authorisation of this novel food and of the reference to the studies contained in the Applicant's file for the sole use of the Applicant, does not prevent other 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 available outside the Applicant's file supporting the authorisation under this Regulation.

Taking into account of the intended use in food supplements for the general adult population, and the fact that the request for authorisation excludes pregnant and lactating women, food supplements containing 1-methylnicotinamide chloride should be appropriately labelled.

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