RT info:eu-repo/semantics/article
T1 Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283
A1 Turck, Dominique
A1 Bohn, Torsten
A1 Castenmiller, Jacqueline
A1 De Henauw, Stefaan
A1 Hirsch‐Ernst, Karen Ildico
A1 Maciuk, Alexandre
A1 Mangelsdorf, Inge
A1 McArdle, Harry J
A1 Naska, Androniki
A1 Peláez, Carmen
A1 Pentieva, Kristina
A1 Siani, Alfonso
A1 Thies, Frank
A1 Tsabouri, Sophia
A1 Vinceti, Marco
A1 Cubadda, Francesco
A1 Frenzel, Thomas
A1 Heinonen, Marina
A1 Prieto Maradona, Miguel
A1 Marchelli, Rosangela
A1 Neuhäuser‐Berthold, Monika
A1 Poulsen, Morten
A1 Schlatter, Josef Rudolf
A1 van Loveren, Henk
A1 Albert, Océane
A1 de Sesmaisons Lecarré, Agnès
A1 Knutsen, Helle Katrine
A2 Nutricion y Bromatologia
K1 Tecnología de los alimentos
K1 Nicotinamide
K1 Nicotinamide riboside chloride
K1 Niacin
K1 Novel food
K1 Nutrient source
K1 Extension of use
K1 3309 Tecnología de Los Alimentos
K1 3206 Ciencias de la Nutrición
AB [EN] 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 (BMDL05) 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.
PB Wiley Open Access
SN 1831-4732
LK https://hdl.handle.net/10612/20642
UL https://hdl.handle.net/10612/20642
NO Turck, D., Bohn, T., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Maciuk, A., Mangelsdorf, I., McArdle, H. J., Naska, A., Pelaez, C., Pentieva, K., Siani, A., Thies, F., Tsabouri, S., Vinceti, M., Cubadda, F., Frenzel, T., Heinonen, M., Prieto Maradona, M., et al. (2021). Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283. EFSA Journal, 19(11), Article e6843. https://doi.org/10.2903/J.EFSA.2021.6843
DS BULERIA. Repositorio Institucional de la Universidad de León
RD Jul 6, 2024