Commission Implementing Regulation (EU) 2024/2694 of 17 October 2024 authorising the placing on the market of magnesium L-threonate as a novel food and amending Implementing Regulation (EU) 2017/2470
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
1. Magnesium L-threonate is authorised to be placed on the market within the Union. Magnesium L-threonate shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470. 2. The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
Only the company AIDP Inc. ( 10 ) is authorised to place on the market within the Union the novel food referred to in Article 1, for a period of 5 years from 7 November 2024, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of AIDP Inc.
The scientific data contained in the application file and fulfilling the conditions laid down in Article 26(2) of Regulation (EU) 2015/2283 shall not be used for the benefit of a subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of AIDP Inc.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows: (1) in Table 1 (Authorised novel foods), the following entry is inserted: Authorised novel food Conditions under which the novel food may be used Additional specific labelling requirements Other requirements Data protection ‘ Magnesium L-threonate Specified food category Maximum levels 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be “Magnesium L-threonate”. 2. The labelling of food supplements containing magnesium L-threonate shall bear a statement that the food supplements should be consumed by adults only, excluding pregnant and lactating women. Authorised on 7 November 2024. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: AIDP Inc., 19535 East Walnut Drive South City of Industry, CA 91748, the United States. During the period of data protection, the novel food magnesium L-threonate is authorised for placing on the market within the Union only by AIDP Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of AIDP Inc. End date of the date protection: 7 November 2029’ Food supplements as defined in Directive 2002/46/EC for adults, excluding pregnant and lactating women 250 mg/day (2) in Table 2 (Specifications), the following entry is inserted: Authorised Novel Food Specification ‘ Magnesium L-threonate Description/Definition: The novel food is produced by chemical synthesis and consists of magnesium L-threonate. Chemical identity: Chemical (IUPAC) name: Magnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate Common name: magnesium L-threonate Molecular formula: C 8 H 16 MgO 11 CAS number: 500304-76-7 Molecular weight: 312,5 Da Characteristics/composition: Appearance: White powder Mg L-threonate monohydrate: 98 %–102 % Magnesium: 7,2 %–8,3 % L-Threonate: 82 %-91 % Oxalic acid: ≤ 1 % Ethanol: ≤ 5 000 ppm Loss on drying: ≤ 5,0 % Microbiological criteria: Total aerobic microbial count: ≤ 100 CFU/g Total yeast and moulds count: ≤ 10 CFU/g E. coli: Not detected in 10 g Salmonella: Not detected in 25 g Abbreviations: CAS: chemical abstracts service, IUPAC: International Union of Pure and Applied Chemistry, CFU: colony forming unit’
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