Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC
Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in fo...
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| Autor*in: |
EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) [verfasserIn] Dominique Turck [verfasserIn] Jacqueline Castenmiller [verfasserIn] Stefaan deHenauw [verfasserIn] Karen Ildico Hirsch‐Ernst [verfasserIn] John Kearney [verfasserIn] Alexandre Maciuk [verfasserIn] Inge Mangelsdorf [verfasserIn] Harry J McArdle [verfasserIn] Androniki Naska [verfasserIn] Carmen Pelaez [verfasserIn] Kristina Pentieva [verfasserIn] Alfonso Siani [verfasserIn] Frank Thies [verfasserIn] Sophia Tsabouri [verfasserIn] Marco Vinceti [verfasserIn] Francesco Cubadda [verfasserIn] Karl‐Heinz Engel [verfasserIn] Thomas Frenzel [verfasserIn] Marina Heinonen [verfasserIn] Rosangela Marchelli [verfasserIn] Monika Neuhäuser‐Berthold [verfasserIn] Annette Pöting [verfasserIn] Morten Poulsen [verfasserIn] Yolanda Sanz [verfasserIn] Josef Rudolf Schlatter [verfasserIn] Henk vanLoveren Agnès de Sesmaisons‐Lecarré [verfasserIn] Andrea Germini [verfasserIn] Helle Katrine Knutsen [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 17(2019), 8, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:17 ; year:2019 ; number:8 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2019.5775 |
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| Katalog-ID: |
DOAJ062211056 |
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| 520 | |a Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. | ||
| 650 | 4 | |a nicotinamide | |
| 650 | 4 | |a nicotinamide riboside chloride | |
| 650 | 4 | |a niacin | |
| 650 | 4 | |a novel food | |
| 650 | 4 | |a nutrient source | |
| 653 | 0 | |a Nutrition. Foods and food supply | |
| 653 | 0 | |a Chemical technology | |
| 700 | 0 | |a Dominique Turck |e verfasserin |4 aut | |
| 700 | 0 | |a Jacqueline Castenmiller |e verfasserin |4 aut | |
| 700 | 0 | |a Stefaan deHenauw |e verfasserin |4 aut | |
| 700 | 0 | |a Karen Ildico Hirsch‐Ernst |e verfasserin |4 aut | |
| 700 | 0 | |a John Kearney |e verfasserin |4 aut | |
| 700 | 0 | |a Alexandre Maciuk |e verfasserin |4 aut | |
| 700 | 0 | |a Inge Mangelsdorf |e verfasserin |4 aut | |
| 700 | 0 | |a Harry J McArdle |e verfasserin |4 aut | |
| 700 | 0 | |a Androniki Naska |e verfasserin |4 aut | |
| 700 | 0 | |a Carmen Pelaez |e verfasserin |4 aut | |
| 700 | 0 | |a Kristina Pentieva |e verfasserin |4 aut | |
| 700 | 0 | |a Alfonso Siani |e verfasserin |4 aut | |
| 700 | 0 | |a Frank Thies |e verfasserin |4 aut | |
| 700 | 0 | |a Sophia Tsabouri |e verfasserin |4 aut | |
| 700 | 0 | |a Marco Vinceti |e verfasserin |4 aut | |
| 700 | 0 | |a Francesco Cubadda |e verfasserin |4 aut | |
| 700 | 0 | |a Karl‐Heinz Engel |e verfasserin |4 aut | |
| 700 | 0 | |a Thomas Frenzel |e verfasserin |4 aut | |
| 700 | 0 | |a Marina Heinonen |e verfasserin |4 aut | |
| 700 | 0 | |a Rosangela Marchelli |e verfasserin |4 aut | |
| 700 | 0 | |a Monika Neuhäuser‐Berthold |e verfasserin |4 aut | |
| 700 | 0 | |a Annette Pöting |e verfasserin |4 aut | |
| 700 | 0 | |a Morten Poulsen |e verfasserin |4 aut | |
| 700 | 0 | |a Yolanda Sanz |e verfasserin |4 aut | |
| 700 | 0 | |a Josef Rudolf Schlatter |e verfasserin |4 aut | |
| 700 | 0 | |a Henk vanLoveren Agnès de Sesmaisons‐Lecarré |e verfasserin |4 aut | |
| 700 | 0 | |a Andrea Germini |e verfasserin |4 aut | |
| 700 | 0 | |a Helle Katrine Knutsen |e verfasserin |4 aut | |
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10.2903/j.efsa.2019.5775 doi (DE-627)DOAJ062211056 (DE-599)DOAJ015228fa2b59465b8375e5496899f9b1 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) verfasserin aut Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. nicotinamide nicotinamide riboside chloride niacin novel food nutrient source Nutrition. Foods and food supply Chemical technology Dominique Turck verfasserin aut Jacqueline Castenmiller verfasserin aut Stefaan deHenauw verfasserin aut Karen Ildico Hirsch‐Ernst verfasserin aut John Kearney verfasserin aut Alexandre Maciuk verfasserin aut Inge Mangelsdorf verfasserin aut Harry J McArdle verfasserin aut Androniki Naska verfasserin aut Carmen Pelaez verfasserin aut Kristina Pentieva verfasserin aut Alfonso Siani verfasserin aut Frank Thies verfasserin aut Sophia Tsabouri verfasserin aut Marco Vinceti verfasserin aut Francesco Cubadda verfasserin aut Karl‐Heinz Engel verfasserin aut Thomas Frenzel verfasserin aut Marina Heinonen verfasserin aut Rosangela Marchelli verfasserin aut Monika Neuhäuser‐Berthold verfasserin aut Annette Pöting verfasserin aut Morten Poulsen verfasserin aut Yolanda Sanz verfasserin aut Josef Rudolf Schlatter verfasserin aut Henk vanLoveren Agnès de Sesmaisons‐Lecarré verfasserin aut Andrea Germini verfasserin aut Helle Katrine Knutsen verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/article/015228fa2b59465b8375e5496899f9b1 kostenfrei https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 8 n/a-n/a |
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10.2903/j.efsa.2019.5775 doi (DE-627)DOAJ062211056 (DE-599)DOAJ015228fa2b59465b8375e5496899f9b1 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) verfasserin aut Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. nicotinamide nicotinamide riboside chloride niacin novel food nutrient source Nutrition. Foods and food supply Chemical technology Dominique Turck verfasserin aut Jacqueline Castenmiller verfasserin aut Stefaan deHenauw verfasserin aut Karen Ildico Hirsch‐Ernst verfasserin aut John Kearney verfasserin aut Alexandre Maciuk verfasserin aut Inge Mangelsdorf verfasserin aut Harry J McArdle verfasserin aut Androniki Naska verfasserin aut Carmen Pelaez verfasserin aut Kristina Pentieva verfasserin aut Alfonso Siani verfasserin aut Frank Thies verfasserin aut Sophia Tsabouri verfasserin aut Marco Vinceti verfasserin aut Francesco Cubadda verfasserin aut Karl‐Heinz Engel verfasserin aut Thomas Frenzel verfasserin aut Marina Heinonen verfasserin aut Rosangela Marchelli verfasserin aut Monika Neuhäuser‐Berthold verfasserin aut Annette Pöting verfasserin aut Morten Poulsen verfasserin aut Yolanda Sanz verfasserin aut Josef Rudolf Schlatter verfasserin aut Henk vanLoveren Agnès de Sesmaisons‐Lecarré verfasserin aut Andrea Germini verfasserin aut Helle Katrine Knutsen verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/article/015228fa2b59465b8375e5496899f9b1 kostenfrei https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 8 n/a-n/a |
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10.2903/j.efsa.2019.5775 doi (DE-627)DOAJ062211056 (DE-599)DOAJ015228fa2b59465b8375e5496899f9b1 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) verfasserin aut Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. nicotinamide nicotinamide riboside chloride niacin novel food nutrient source Nutrition. Foods and food supply Chemical technology Dominique Turck verfasserin aut Jacqueline Castenmiller verfasserin aut Stefaan deHenauw verfasserin aut Karen Ildico Hirsch‐Ernst verfasserin aut John Kearney verfasserin aut Alexandre Maciuk verfasserin aut Inge Mangelsdorf verfasserin aut Harry J McArdle verfasserin aut Androniki Naska verfasserin aut Carmen Pelaez verfasserin aut Kristina Pentieva verfasserin aut Alfonso Siani verfasserin aut Frank Thies verfasserin aut Sophia Tsabouri verfasserin aut Marco Vinceti verfasserin aut Francesco Cubadda verfasserin aut Karl‐Heinz Engel verfasserin aut Thomas Frenzel verfasserin aut Marina Heinonen verfasserin aut Rosangela Marchelli verfasserin aut Monika Neuhäuser‐Berthold verfasserin aut Annette Pöting verfasserin aut Morten Poulsen verfasserin aut Yolanda Sanz verfasserin aut Josef Rudolf Schlatter verfasserin aut Henk vanLoveren Agnès de Sesmaisons‐Lecarré verfasserin aut Andrea Germini verfasserin aut Helle Katrine Knutsen verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/article/015228fa2b59465b8375e5496899f9b1 kostenfrei https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 8 n/a-n/a |
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10.2903/j.efsa.2019.5775 doi (DE-627)DOAJ062211056 (DE-599)DOAJ015228fa2b59465b8375e5496899f9b1 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) verfasserin aut Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. nicotinamide nicotinamide riboside chloride niacin novel food nutrient source Nutrition. Foods and food supply Chemical technology Dominique Turck verfasserin aut Jacqueline Castenmiller verfasserin aut Stefaan deHenauw verfasserin aut Karen Ildico Hirsch‐Ernst verfasserin aut John Kearney verfasserin aut Alexandre Maciuk verfasserin aut Inge Mangelsdorf verfasserin aut Harry J McArdle verfasserin aut Androniki Naska verfasserin aut Carmen Pelaez verfasserin aut Kristina Pentieva verfasserin aut Alfonso Siani verfasserin aut Frank Thies verfasserin aut Sophia Tsabouri verfasserin aut Marco Vinceti verfasserin aut Francesco Cubadda verfasserin aut Karl‐Heinz Engel verfasserin aut Thomas Frenzel verfasserin aut Marina Heinonen verfasserin aut Rosangela Marchelli verfasserin aut Monika Neuhäuser‐Berthold verfasserin aut Annette Pöting verfasserin aut Morten Poulsen verfasserin aut Yolanda Sanz verfasserin aut Josef Rudolf Schlatter verfasserin aut Henk vanLoveren Agnès de Sesmaisons‐Lecarré verfasserin aut Andrea Germini verfasserin aut Helle Katrine Knutsen verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/article/015228fa2b59465b8375e5496899f9b1 kostenfrei https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 8 n/a-n/a |
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10.2903/j.efsa.2019.5775 doi (DE-627)DOAJ062211056 (DE-599)DOAJ015228fa2b59465b8375e5496899f9b1 DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) verfasserin aut Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. nicotinamide nicotinamide riboside chloride niacin novel food nutrient source Nutrition. Foods and food supply Chemical technology Dominique Turck verfasserin aut Jacqueline Castenmiller verfasserin aut Stefaan deHenauw verfasserin aut Karen Ildico Hirsch‐Ernst verfasserin aut John Kearney verfasserin aut Alexandre Maciuk verfasserin aut Inge Mangelsdorf verfasserin aut Harry J McArdle verfasserin aut Androniki Naska verfasserin aut Carmen Pelaez verfasserin aut Kristina Pentieva verfasserin aut Alfonso Siani verfasserin aut Frank Thies verfasserin aut Sophia Tsabouri verfasserin aut Marco Vinceti verfasserin aut Francesco Cubadda verfasserin aut Karl‐Heinz Engel verfasserin aut Thomas Frenzel verfasserin aut Marina Heinonen verfasserin aut Rosangela Marchelli verfasserin aut Monika Neuhäuser‐Berthold verfasserin aut Annette Pöting verfasserin aut Morten Poulsen verfasserin aut Yolanda Sanz verfasserin aut Josef Rudolf Schlatter verfasserin aut Henk vanLoveren Agnès de Sesmaisons‐Lecarré verfasserin aut Andrea Germini verfasserin aut Helle Katrine Knutsen verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 8, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:8 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/article/015228fa2b59465b8375e5496899f9b1 kostenfrei https://doi.org/10.2903/j.efsa.2019.5775 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 8 n/a-n/a |
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EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) @@aut@@ Dominique Turck @@aut@@ Jacqueline Castenmiller @@aut@@ Stefaan deHenauw @@aut@@ Karen Ildico Hirsch‐Ernst @@aut@@ John Kearney @@aut@@ Alexandre Maciuk @@aut@@ Inge Mangelsdorf @@aut@@ Harry J McArdle @@aut@@ Androniki Naska @@aut@@ Carmen Pelaez @@aut@@ Kristina Pentieva @@aut@@ Alfonso Siani @@aut@@ Frank Thies @@aut@@ Sophia Tsabouri @@aut@@ Marco Vinceti @@aut@@ Francesco Cubadda @@aut@@ Karl‐Heinz Engel @@aut@@ Thomas Frenzel @@aut@@ Marina Heinonen @@aut@@ Rosangela Marchelli @@aut@@ Monika Neuhäuser‐Berthold @@aut@@ Annette Pöting @@aut@@ Morten Poulsen @@aut@@ Yolanda Sanz @@aut@@ Josef Rudolf Schlatter @@aut@@ Henk vanLoveren Agnès de Sesmaisons‐Lecarré @@aut@@ Andrea Germini @@aut@@ Helle Katrine Knutsen @@aut@@ |
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The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. 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EFSA Panel on Nutrition, Novel foods and Food allergens (NDA) Dominique Turck Jacqueline Castenmiller Stefaan deHenauw Karen Ildico Hirsch‐Ernst John Kearney Alexandre Maciuk Inge Mangelsdorf Harry J McArdle Androniki Naska Carmen Pelaez Kristina Pentieva Alfonso Siani Frank Thies Sophia Tsabouri Marco Vinceti Francesco Cubadda Karl‐Heinz Engel Thomas Frenzel Marina Heinonen Rosangela Marchelli Monika Neuhäuser‐Berthold Annette Pöting Morten Poulsen Yolanda Sanz Josef Rudolf Schlatter Henk vanLoveren Agnès de Sesmaisons‐Lecarré Andrea Germini Helle Katrine Knutsen |
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safety of nicotinamide riboside chloride as a novel food pursuant to regulation (eu) 2015/2283 and bioavailability of nicotinamide from this source, in the context of directive 2002/46/ec |
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Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC |
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Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. |
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Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. |
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Abstract Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Allergens (NDA) was asked to deliver an opinion on nicotinamide riboside chloride as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including an evaluation of the safety of its use in food supplements as a source of niacin, and the bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC. The NF, a synthetic form of nicotinamide riboside, is proposed to be used in food supplements for the healthy adult population at levels up to 300 mg/day. The production process, composition, specifications, batch‐to‐batch variability and stability of the NF do not raise safety concerns. Animal and human data indicate that the NF contributes to the nicotinamide body pool. There are no concerns regarding genotoxicity. Human studies do not raise safety concerns. The proposed maximum use level corresponds to an amount of nicotinamide, which is sixfold lower than the tolerable upper intake level (UL) set for adults, excluding pregnant and lactating women. The margin of exposure (MoE) of 70 derived from repeated dose toxicity studies with rats and dogs is considered sufficient for the adult population, excluding pregnant and lactating women. Regarding these two population groups, the MoE of 76 derived from a developmental toxicity study in rats is considered insufficient in the absence of data which could justify accepting a MoE lower than 100. The Panel concludes that the NF is safe under the proposed conditions of use for the healthy adult population, excluding pregnant and lactating women, and that an intake of the NF up to 230 mg/day is safe for pregnant and lactating women. The Panel also concludes that the NF is a source from which nicotinamide, a form of niacin, is bioavailable. |
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Safety of nicotinamide riboside chloride as a novel food pursuant to Regulation (EU) 2015/2283 and bioavailability of nicotinamide from this source, in the context of Directive 2002/46/EC |
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| score |
7.399722 |