Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foodsnote, and in particular Article 3(3) thereof,Whereas:
(1)Annexes I and II to Regulation (EC) No 1925/2006 establish the list of vitamin and mineral substances, and for each of them the forms, which may be added to foods.
(2)Commission Implementing Regulation (EU) 2020/16note authorised the placing on the market of nicotinamide riboside chloride as a novel food for use in food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Councilnote, for the adult population.
(3)As the initial authorisation of this substance as a novel food as set out in Implementing Regulation (EU) 2020/16 concerned only food supplements, the substance has been included in the list set out in Annex II to Directive 2002/46/EC by Commission Regulation (EU) 2021/418note. Following an application for extension of the use of nicotinamide riboside chloride as a novel food to cover also its use for nutritional purposes as a source of niacin, in particular, in meal replacements, the Commission requested the European Food Safety Authority (‘the Authority’) to deliver an opinion on such extension of use in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Councilnote and, following the outcome of that assessment, to evaluate in the context of Regulation (EC) No 1925/2006, the safety and bio-availability of that substance when added to the foods in question. On 14 September 2021, the Authority adopted a scientific opinion on the extension of use of nicotinamide riboside chloride as a novel foodnote.
(4)It follows from that opinion that the use of nicotinamide riboside chloride in foods is not of safety concern as a source of niacin provided that certain conditions are fulfilled. Those conditions are set out in the authorisation of this substance by Commission Implementing Regulation (EU) 2022/1160note.
(5)In accordance with Article 3(1) of Regulation (EC) No 1925/2006, only vitamins and/or minerals listed in Annex I, in the form listed in Annex II to that act may be added to foods. Based on the Authority’s favourable opinion and on the authorisation as a novel food as set out in Implementing Regulation (EU) 2022/1160, nicotinamide riboside chloride should be included in in Annex II to Regulation (EC) No 1925/2006 as a form of niacin.
(6)The Advisory Group on the Food Chain and Animal and Plant Health was consulted and its comments were taken into consideration.
(7)Regulation (EC) No 1925/2006 should therefore be amended accordingly.
(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1#
Annex II to Regulation (EC) No 1925/2006 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
In Annex II to Regulation (EC) No 1925/2006, within Point 1 on ‘Vitamin formulations’, under ‘NIACIN’, the following entry is added after the entry for ‘nicotinamide’:
‘nicotinamide riboside chloride’.
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