Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283
Abstract 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 ass...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-11-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2021.6843 |
| _version_ | 1818401369638305792 |
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| author | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Henk van Loveren Océane Albert Agnès de Sesmaisons Lecarré Helle Katrine Knutsen |
| author_facet | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Henk van Loveren Océane Albert Agnès de Sesmaisons Lecarré Helle Katrine Knutsen |
| author_sort | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-14T07:51:23Z |
| format | Article |
| id | doaj.art-e13d0d9ed38a4a8c803c2a2a44746808 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-14T07:51:23Z |
| publishDate | 2021-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-e13d0d9ed38a4a8c803c2a2a447468082022-12-21T23:10:41ZengWileyEFSA Journal1831-47322021-11-011911n/an/a10.2903/j.efsa.2021.6843Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstAlexandre MaciukInge MangelsdorfHarry J McArdleAndroniki NaskaCarmen PelaezKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiFrancesco CubaddaThomas FrenzelMarina HeinonenMiguel Prieto MaradonaRosangela MarchelliMonika Neuhäuser‐BertholdMorten PoulsenJosef Rudolf SchlatterHenk van LoverenOcéane AlbertAgnès de Sesmaisons LecarréHelle Katrine KnutsenAbstract 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.https://doi.org/10.2903/j.efsa.2021.6843nicotinamidenicotinamide riboside chlorideniacinnovel foodnutrient sourceextension of use |
| spellingShingle | EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) Dominique Turck Torsten Bohn Jacqueline Castenmiller Stefaan De Henauw Karen Ildico Hirsch‐Ernst Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Thomas Frenzel Marina Heinonen Miguel Prieto Maradona Rosangela Marchelli Monika Neuhäuser‐Berthold Morten Poulsen Josef Rudolf Schlatter Henk van Loveren Océane Albert Agnès de Sesmaisons Lecarré Helle Katrine Knutsen Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 EFSA Journal nicotinamide nicotinamide riboside chloride niacin novel food nutrient source extension of use |
| title | Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full | Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_fullStr | Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_full_unstemmed | Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_short | Extension of use of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 |
| title_sort | extension of use of nicotinamide riboside chloride as a novel food pursuant to regulation eu 2015 2283 |
| topic | nicotinamide nicotinamide riboside chloride niacin novel food nutrient source extension of use |
| url | https://doi.org/10.2903/j.efsa.2021.6843 |
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