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
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 magnesi...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-03-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2024.8656 |
| _version_ | 1797235663725133824 |
|---|---|
| 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 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 |
| 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 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 |
| 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 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. |
| first_indexed | 2024-04-24T16:51:33Z |
| format | Article |
| id | doaj.art-31839fd3a7f54c1eb05fff2e520f4c13 |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-24T16:51:33Z |
| publishDate | 2024-03-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-31839fd3a7f54c1eb05fff2e520f4c132024-03-29T03:10:39ZengWileyEFSA Journal1831-47322024-03-01223n/an/a10.2903/j.efsa.2024.8656Safety 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/ECEFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA)Dominique TurckTorsten BohnJacqueline CastenmillerStefaan De HenauwKaren Ildico Hirsch‐ErnstAlexandre MaciukInge MangelsdorfHarry J. McArdleAndroniki NaskaKristina PentievaAlfonso SianiFrank ThiesSophia TsabouriMarco VincetiMargarita Aguilera‐GómezFrancesco CubaddaThomas FrenzelMarina HeinonenRosangela MarchelliMonika Neuhäuser‐BertholdMorten PoulsenMiguel Prieto MaradonaJosef Rudolf SchlatterAlexandros SiskosHenk vanLoverenWolfgang GelbmannHelle 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 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.https://doi.org/10.2903/j.efsa.2024.8656bioavailabilityfood supplementmagnesium l‐threonatenovel foodsnutrient sourcesafety |
| 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 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 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 EFSA Journal bioavailability food supplement magnesium l‐threonate novel foods nutrient source safety |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | bioavailability food supplement magnesium l‐threonate novel foods nutrient source safety |
| url | https://doi.org/10.2903/j.efsa.2024.8656 |
| work_keys_str_mv | AT efsapanelonnutritionnovelfoodsandfoodallergensnda safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT dominiqueturck safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT torstenbohn safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT jacquelinecastenmiller safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT stefaandehenauw safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT karenildicohirschernst safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT alexandremaciuk safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT ingemangelsdorf safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT harryjmcardle safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT andronikinaska safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT kristinapentieva safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT alfonsosiani safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT frankthies safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT sophiatsabouri safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT marcovinceti safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT margaritaaguileragomez safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT francescocubadda safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT thomasfrenzel safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT marinaheinonen safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT rosangelamarchelli safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT monikaneuhauserberthold safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT mortenpoulsen safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT miguelprietomaradona safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT josefrudolfschlatter safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT alexandrossiskos safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT henkvanloveren safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT wolfganggelbmann safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec AT hellekatrineknutsen safetyofmagnesiumlthreonateasanovelfoodpursuanttoregulationeu20152283andbioavailabilityofmagnesiumfromthissourceinthecontextofdirective200246ec |