Commission Regulation (EU) 2025/2225 of 5 November 2025 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards magnesium L-threonate as a source of magnesium used in the manufacture of food supplements

Official Journal EN of the European Union L series 2025/2225 6.11.2025 COMMISSION REGULATION(EU) 2025/2225 of 5 November 2025 amending Annex II to Directive 2002/46/EC of the European Parliament and of the Council as regards magnesium L-threonate as a source of magnesium used in the manufacture of food supplements (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(1), and in particular Article 4(5) thereof,

Whereas:

(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,

(1) OJ L 183, 12.7.2002, p. 51, ELI: http://data.europa.eu/eli/dir/2002/46/oj.

(2) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1, ELI: http:// data.europa.eu/eli/reg/2015/2283/oj).

(3) EFSA NDA Panel. Safety of magnesium L-threonate as a novel food pursuant to regulation (EU) 2015/2283 and bioavailability of magnesium from this source in the context of Directive 2002/46/EC, https://doi.org/10.2903/j.efsa.2024.8656.

(4) 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 (OJ L, 2024/2694, 18.10.2024, ELI: http://data.

europa.eu/eli/reg_impl/2024/2694/oj).

ELI: http://data.europa.eu/eli/reg/2025/2225/oj 1/3EN OJ L, 6.11.2025

HAS ADOPTED THIS REGULATION:

Article 1 Annex II to Directive 2002/46/EC is amended in accordance with the Annex to this Regulation.

Article 2 This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 5 November 2025.

For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg/2025/2225/ojEN OJ L, 6.11.2025 ANNEX In point B of Annex II to Directive 2002/46/EC, the following entry is inserted between the entries for ‘magnesium acetyl taurate’ and ‘ferrous carbonate’:

‘magnesium L-threonate(*) _____________ (*) As listed in the Union list of novel foods in Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72, ELI: http://data.europa.eu/eli/reg_impl/ 2017/2470/oj).’

ELI: http://data.europa.eu/eli/reg/2025/2225/oj 3/3