Cargando…

Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1‐methylnicotinamide chloride (1‐MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and...

Descripción completa

Detalles Bibliográficos
Autores principales: Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Neuhäuser‐Berthold, Monika, Nowicka, Grażyna, Pentieva, Kristina, Sanz, Yolanda, Siani, Alfonso, Sjödin, Anders, Stern, Martin, Tomé, Daniel, Vinceti, Marco, Willatts, Peter, Engel, Karl‐Heinz, Marchelli, Rosangela, Pöting, Annette, Poulsen, Morten, Schlatter, Josef Rudolf, Gelbmann, Wolfgang, Ververis, Ermolaos, van Loveren, Henk
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010160/
https://www.ncbi.nlm.nih.gov/pubmed/32625296
http://dx.doi.org/10.2903/j.efsa.2017.5001
_version_ 1783495826528534528
author Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Gelbmann, Wolfgang
Ververis, Ermolaos
van Loveren, Henk
author_facet Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Gelbmann, Wolfgang
Ververis, Ermolaos
van Loveren, Henk
collection PubMed
description Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1‐methylnicotinamide chloride (1‐MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 1‐MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panel considers that the information provided on the composition, the specification and the batch‐to‐batch variability of the NF is sufficient. The applicant intends to use 1‐MNA in food supplements and proposes a maximum intake of 58 mg/day. 1‐MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non‐glandular stomach was observed at all dose levels with increasing frequency. The Panel notes that the human stomach does not have non‐glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000 mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panel selected 250 mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70 kg and consuming 58 mg would be about 300. The Panel notes the upper level for nicotinamide, i.e. 900 mg/day for adults. Taking into account that 1‐MNA is a main metabolite from nicotinamide, the Panel considers that it is unlikely that an intake of 58 mg 1‐MNA from food supplements would result in adverse health outcomes in humans. The Panel concludes that the NF, 1‐MNA, is safe under the proposed uses and use levels.
format Online
Article
Text
id pubmed-7010160
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-70101602020-07-02 Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97 Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Gelbmann, Wolfgang Ververis, Ermolaos van Loveren, Henk EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1‐methylnicotinamide chloride (1‐MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 1‐MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panel considers that the information provided on the composition, the specification and the batch‐to‐batch variability of the NF is sufficient. The applicant intends to use 1‐MNA in food supplements and proposes a maximum intake of 58 mg/day. 1‐MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non‐glandular stomach was observed at all dose levels with increasing frequency. The Panel notes that the human stomach does not have non‐glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000 mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panel selected 250 mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70 kg and consuming 58 mg would be about 300. The Panel notes the upper level for nicotinamide, i.e. 900 mg/day for adults. Taking into account that 1‐MNA is a main metabolite from nicotinamide, the Panel considers that it is unlikely that an intake of 58 mg 1‐MNA from food supplements would result in adverse health outcomes in humans. The Panel concludes that the NF, 1‐MNA, is safe under the proposed uses and use levels. John Wiley and Sons Inc. 2017-10-26 /pmc/articles/PMC7010160/ /pubmed/32625296 http://dx.doi.org/10.2903/j.efsa.2017.5001 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Scientific Opinion
Turck, Dominique
Bresson, Jean‐Louis
Burlingame, Barbara
Dean, Tara
Fairweather‐Tait, Susan
Heinonen, Marina
Hirsch‐Ernst, Karen Ildico
Mangelsdorf, Inge
McArdle, Harry J
Naska, Androniki
Neuhäuser‐Berthold, Monika
Nowicka, Grażyna
Pentieva, Kristina
Sanz, Yolanda
Siani, Alfonso
Sjödin, Anders
Stern, Martin
Tomé, Daniel
Vinceti, Marco
Willatts, Peter
Engel, Karl‐Heinz
Marchelli, Rosangela
Pöting, Annette
Poulsen, Morten
Schlatter, Josef Rudolf
Gelbmann, Wolfgang
Ververis, Ermolaos
van Loveren, Henk
Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title_full Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title_fullStr Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title_full_unstemmed Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title_short Safety of 1‐methylnicotinamide chloride (1‐MNA) as a novel food pursuant to Regulation (EC) No 258/97
title_sort safety of 1‐methylnicotinamide chloride (1‐mna) as a novel food pursuant to regulation (ec) no 258/97
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010160/
https://www.ncbi.nlm.nih.gov/pubmed/32625296
http://dx.doi.org/10.2903/j.efsa.2017.5001
work_keys_str_mv AT safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT turckdominique safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT bressonjeanlouis safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT burlingamebarbara safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT deantara safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT fairweathertaitsusan safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT heinonenmarina safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT hirschernstkarenildico safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT mangelsdorfinge safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT mcardleharryj safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT naskaandroniki safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT neuhauserbertholdmonika safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT nowickagrazyna safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT pentievakristina safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT sanzyolanda safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT sianialfonso safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT sjodinanders safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT sternmartin safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT tomedaniel safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT vincetimarco safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT willattspeter safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT engelkarlheinz safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT marchellirosangela safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT potingannette safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT poulsenmorten safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT schlatterjosefrudolf safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT gelbmannwolfgang safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT ververisermolaos safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897
AT vanloverenhenk safetyof1methylnicotinamidechloride1mnaasanovelfoodpursuanttoregulationecno25897