Open AccessExtension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation ( EU ) 2015/2283
Author(s) -
Turck Dominique,
Bohn Torsten,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Frenzel Thomas,
Hein Marina,
Prieto Maradona Miguel,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Schlatter Josef Rudolf,
van Loveren Henk,
Albert Océane,
de Sesmaisons Lecarré Agnès,
Knutsen Helle Katrine
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6843
Subject(s) - acceptable daily intake , meal , nicotinamide , medicine , european union , toxicology , environmental health , food safety , population , multivitamin , food science , zoology , biology , business , biochemistry , pesticide , agronomy , enzyme , economic policy , vitamin
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens ( NDA ) was asked to deliver an opinion on the safety of an extension of use of the novel food ( NF ) nicotinamide riboside chloride ( NRC ) pursuant to Regulation ( EU ) 2015/2283. The assessment addresses the use of NRC in ‘meal replacement products’ and ‘nutritional drink mixes’ at levels up to 300 mg/day for the general population, and in food for special medical purposes ( FSMP ) and total diet replacement for weight control ( TDRWC ) (as per Regulation ( EU ) No 609/2013) at levels up to 500 mg/day in adults. Benchmark dose modelling was carried out on data from the 90‐day oral toxicity studies in rats relevant to the safety assessment. Considering the lack of tolerable upper intake level ( UL ) for nicotinamide in infants and the narrow margin of exposure between the estimated intake in infants and the lower confidence bound of the benchmark doses ( BMDL 05 ) estimated by the models, the Panel concludes that the safety of the NF has not been established for use in ‘meal replacement products’ and ‘nutritional drink mixes’ under the proposed conditions of use. For FSMP and TDRWC , the proposed maximum use level corresponds to an intake of 210 mg nicotinamide per day, which is below the current UL for nicotinamide of 900 mg/day for adults. The Panel considers that the NF is as safe as pure nicotinamide for use in FSMP and TDRWC . The Panel, however, notes experimental data which indicate several pathways by which intakes of nicotinamide (or its precursors), at levels that are substantially higher than the physiological requirement, might cause adverse effects. The Panel considers that further investigations are required and that a re‐evaluation of the UL for nicotinamide may be warranted.