(1)

Annexes I and II to Directive 2002/46/EC establish the lists of vitamin and mineral substances, and for each of them the forms, which may be used in the manufacture of food supplements.

(2)

Following a request from the European Commission, the European Food Safety Authority (‘the Authority’) was asked to deliver an opinion on the safety of magnesium L-threonate as a novel food pursuant to Regulation (EU) 2015/2283 of the European Parliament and of the Council (2) and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC.

(3)

On 30 January 2024, the Authority adopted a scientific opinion (3), where it concluded that magnesium L-threonate is safe under the proposed conditions of use and that it is a source from which magnesium is bioavailable.

(4)

Commission Implementing Regulation (EU) 2024/2694 (4) authorised, based on the Authority’s scientific opinion, the placing on the market of magnesium L-threonate as a novel food for use in food supplements, subject to specific conditions.

(5)

The Commission considers that the Authority’s scientific opinion of 2024 gives sufficient grounds to establish that magnesium L-threonate used in food supplements as authorized by Implementing Regulation (EU) 2024/2694 is not of safety concern as a source of magnesium.

(6)

Therefore, magnesium L-threonate should be included in the list of vitamin and mineral substances set out in Annex II to Directive 2002/46/EC, in order to allow its use as a source of magnesium in food supplements.

(7)

Directive 2002/46/EC should therefore be amended accordingly.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,