EU Publishes Safety of Iron hydroxide adipate tartrate as a Novel Food

Posted By: Trace One

On December 10th, 2021, the European Food Safety on Nutrition, Novel Foods and Food Allergens (NDA) delivered the “Safety of iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC”.

The scope of the assessment highlights the following:

  • Use of Novel Food in food supplements at a maximum use level of 100 mg per day (corresponds to a maximum daily intake of iron of 36mg);
  • The assessment indicates target population of above 3 years of age;
  • The study of absorption, distribution, metabolism, and excretion (ADME) and bioavailability indicates the mechanism of iron once in the gut, the absorption is the same as that of other forms of iron;
  • The Novel food source from which iron is bioavailable is found to be safe under the proposed conditions of use;
  • The toxicological assessment indicates the Novel food does not lead to iron bioaccumulation in tissues and organs;
  • Novel food contains nickel at concentrations that may increase the risk of flare‐up reactions in nickel‐sensitized young individuals up to 10 years of age.

To view the complete safety assessment report, check out the Food News Monitoring System.