Date: 2025-11-06Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Regulation (EU) 2025/2225, dated November 5, 2025, amends Annex II to Directive 2002/46/EC to include magnesium L-threonate as a permissible source of magnesium in the manufacture of food supplements. It enters into force twenty days following its publication in the Official Journal of the European Union. The regulation is binding in its entirety and directly applicable in all Member States.
**Key Points / Main Content**
* **Amendment of Directive 2002/46/EC:**
* Annex II to Directive 2002/46/EC is amended to include magnesium L-threonate as a source of magnesium for use in food supplements.
* The addition is inserted between "magnesium acetyl taurate" and "ferrous carbonate" in point B of Annex II.
* Magnesium L-threonate is to be listed in accordance with Commission Implementing Regulation (EU) 2017/2470 (Union list of novel foods).
* **Legal Basis & Justification:**
* The European Food Safety Authority (EFSA) provided a scientific opinion in January 2024 that magnesium L-threonate is safe and bioavailable under specified conditions.
* Commission Implementing Regulation (EU) 2024/2694 authorized placing it on the market as a novel food for food supplements.
* The Commission considers the Authority's scientific opinion sufficient to establish that magnesium L-threonate is not of safety concern as a source of magnesium.
**Impact Analysis**
**Stakeholder: Food Supplement Manufacturers**
* **Impact:** Can now legally use magnesium L-threonate as a source of magnesium in their food supplements within the EU.
* **Action Required:** Ensure magnesium L-threonate used complies with the specifications and conditions outlined in Implementing Regulation (EU) 2017/2470.
**Stakeholder: EU Member States**
* **Impact:** Required to enforce the amended Directive 2002/46/EC in their respective jurisdictions.
* **Action Required:** Incorporate the changes into national legislation and monitor compliance.
**Stakeholder: Consumers**
* **Impact:** Increased availability of food supplements containing magnesium L-threonate.
* **Action Required:** No direct action required.
Key Entities Referenced
Directive 2002/46/EC: Directive of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements, amended by this regulation.
Regulation (EU) 2015/2283: Regulation of the European Parliament and of the Council on novel foods, referenced for the assessment of magnesium L-threonate.
Commission Implementing Regulation (EU) 2024/2694: Regulation authorizing the placing on the market of magnesium L-threonate as a novel food.
Magnesium L-threonate: The substance being added as an authorized form of magnesium for use in food supplements.
European Food Safety Authority ('the Authority'): Provided scientific opinions on the safety and bioavailability of magnesium L-threonate.
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