Risk assessment
Safety Assessment: Magnesium L-threonate as a novel food for use in food supplements
Summary
An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in April 2021 from AIDP, USA (“the applicant”) for the authorisation of magnesium L-threonate monohydrate as a novel food.
The novel food is magnesium L-threonate monohydrate which is intended to be used as a source of magnesium in food supplements. Magnesium L-threonate monohydrate is manufactured via a chemical synthetic process, isolated, purified and then dried to a powder.
This new application is seeking to use the novel food within the food category: food supplement.
To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe, and not putting consumers at a nutritional disadvantage.
The FSA and FSS concluded that the applicant had provided sufficient information to assure the novel food, magnesium L-threonate monohydrate, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in food supplements was not considered to be nutritionally disadvantageous.
The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.