Safety of magnesium l‐threonate as a novel food pursuant to regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC

Bibliographic Details
Title: Safety of magnesium l‐threonate as a novel food pursuant to regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC
Authors: 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, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Margarita Aguilera‐Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Rosangela Marchelli, Monika Neuhäuser‐Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk vanLoveren, Wolfgang Gelbmann, Helle Katrine Knutsen
Source: EFSA Journal, Vol 22, Iss 3, Pp n/a-n/a (2024)
Publisher Information: Wiley, 2024.
Publication Year: 2024
Collection: LCC:Nutrition. Foods and food supply
LCC:Chemical technology
Subject Terms: bioavailability, food supplement, magnesium l‐threonate, novel foods, nutrient source, safety, Nutrition. Foods and food supply, TX341-641, Chemical technology, TP1-1185
More Details: 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 magnesium l‐threonate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF, produced by chemical synthesis, is intended to be used as new source for magnesium in food supplements at a maximum intake level of 3000 mg per day by adults, except for pregnant and lactating women. This dose corresponds to ~ 2730 mg l‐threonate and 250 mg magnesium, which also corresponds to the UL for supplemental magnesium from readily dissociable magnesium salts. Based on results obtained from a dissociation study, two rat studies and one human trial, the Panel considers that magnesium is bioavailable from the NF. The NF may contain up to 1% oxalic acid. The Panel considers that an additional exposure to oxalic acid, that is up to 30 mg daily from the NF, is not to be of safety concern. The Panel concludes that the NF is not nutritionally disadvantageous. In 2008, the EFSA ANS Panel concluded that a human intake of l‐threonate of 2700 mg per day is safe. This intake is similar to the maximum intake of l‐threonate from the NF under the maximum proposed uses, and the NDA Panel concurs with the ANS Panel that this intake is safe. The Panel considers that there are no concerns regarding the genotoxicity of the NF. The Panel concludes that the NF, Mg l‐threonate, is safe under the proposed conditions of use. The Panel concludes that the NF is a source from which magnesium is bioavailable.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 1831-4732
Relation: https://doaj.org/toc/1831-4732
DOI: 10.2903/j.efsa.2024.8656
Access URL: https://doaj.org/article/31839fd3a7f54c1eb05fff2e520f4c13
Accession Number: edsdoj.31839fd3a7f54c1eb05fff2e520f4c13
Database: Directory of Open Access Journals
More Details
ISSN:18314732
DOI:10.2903/j.efsa.2024.8656
Published in:EFSA Journal
Language:English