Evaluation of di‐magnesium malate, used as a novel food ingredient and as a source of magnesium in foods for the general population, food supplements, total diet replacement for weight control and food for special medical purposes

The Panel considered that the scientific evidence submitted by the applicant does not demonstrate the difference between ‘dimagnesium malate ’, which is subject of the application under evaluation and ‘magnesium malate’ which is already included in Annex II to Directive 2002/46/EC as one of the mineral substances which may be added to food supplements, following a scientific opinion by European Food Safety Authority AFC Panel

EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Maged Younes; Peter Aggett; Fernando Aguilar; Riccardo Crebelli; Birgit Dusemund; Metka Filipič; Maria Jose Frutos; Pierre Galtier; Ursula Gundert‐Remy; Gunter Georg Kuhnle; Claude Lambré; Jean‐Charles Leblanc; Inger Therese Lillegaard; Peter Moldeus; Alicja Mortensen; Agneta Oskarsson; Ivan Stankovic; Ine Waalkens‐Berendsen; Rudolf Antonius Woutersen; Matthew Wright; Harry McArdle; Paul Tobback; Fabiola Pizzo; Ana Rincon; Camilla Smeraldi; David Gott

2018

Scholarcy highlights

  • The Panel considered that the scientific evidence submitted by the applicant does not demonstrate the difference between ‘dimagnesium malate’, which is subject of the application under evaluation and ‘magnesium malate’ which is already included in Annex II to Directive 2002/46/EC as one of the mineral substances which may be added to food supplements, following a scientific opinion by European Food Safety Authority AFC Panel
  • On the basis of the available data, the Panel concluded that there was insufficient scientific evidence of a difference between the proposed novel food ingredient named as di-magnesium malate and magnesium malate already authorised as a source of magnesium included in Annex II to Directive 2002/46/EC
  • The Panel concluded that based on the data provided it was not possible to assess the dissociation of DMM into magnesium and malic acid
  • According to the applicant, DMM is a compound containing a magnesium malate complex and is described as follows: Chemical name: CAS number: Synonyms: Trade name Chemical formula Molecular weight Description of physical state
  • The Panel noted that the applicant has provided results from an experimental study in support of the dissociation of DMM at low pH into magnesium and malic acid
  • On the basis of the data available, the Panel concluded that the information provided by the applicant is not sufficient to evaluate the dissociation of DMM into magnesium and malic acid; Tier 1 toxicity studies would be needed to evaluate the safety of DMM

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