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

      EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), , , , , , , , , , , , , , , , , , , , , , , , , , , ,

      EFSA Journal

      John Wiley and Sons Inc.

      1‐methylnicotinamide chloride, 1‐MNA, novel food, ingredient, safety

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          Abstract

          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.

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          Most cited references 17

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          Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment

          (2011)
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            Scientific Opinion on Dietary Reference Values for niacin

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              Effect of the Rate of Niacin Administration on the Plasma and Urine Pharmacokinetics of Niacin and Its Metabolites

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                Author and article information

                Journal
                EFSA J
                EFSA J
                10.1002/(ISSN)1831-4732
                EFS2
                EFSA Journal
                John Wiley and Sons Inc. (Hoboken )
                1831-4732
                26 October 2017
                October 2017
                : 15
                : 10 ( doiID: 10.1002/efs2.2017.15.issue-10 )
                Author notes
                Article
                EFS25001
                10.2903/j.efsa.2017.5001
                7010160
                © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

                This is an open access article under the terms of the http://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.

                Page count
                Figures: 1, Tables: 2, Pages: 16, Words: 7452
                Product
                Categories
                Scientific Opinion
                Scientific Opinion
                Custom metadata
                2.0
                October 2017
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.7.5 mode:remove_FC converted:21.01.2020

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