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

• CELEX: Implementing Regulation (EU) 2024/2694
• Articles: 5

Article 1

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.

Article 2

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.

Article 3

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.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

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’