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Welsh Statutory Instruments

2026 No. 56

FOOD, WALES

The Food Supplements (Magnesium L-threonate monohydrate) (Wales) Regulations 2026

Made

26 February 2026

Coming into force

5 March 2026

The Welsh Ministers, in exercise of the powers conferred by regulations 2(2), 3 and 5(1) of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019(1), make the following Regulations.

There has been consultation as required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(2).

These Regulations have been laid before Senedd Cymru in accordance with the Senedd approval procedure under regulation 8(3) of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019(3).

Title, coming into force and extent

1. —(1) The title of these Regulations is the Food Supplements (Magnesium L-threonate monohydrate) (Wales) Regulations 2026.

(2) These Regulations come into force on 5 March 2026.

(3) These Regulations extend to England and Wales.

Amendment of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019

1. —(1) Schedule 2 to the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (vitamin and mineral substances which may be used in the manufacture of food supplements)(4) is amended as follows.

(2) In Part B (minerals) of the table, after the entry “magnesium citrate malate” insert “magnesium L-threonate monohydrate (in relation to Wales)”.

Purity criteria for magnesium L-threonate monohydrate

1. The purity criteria for magnesium L-threonate monohydrate are set out in the Schedule.

Sarah Murphy

Minister for Mental Health and Wellbeing, under the authority of the Cabinet Secretary for Health and Social Care, one of the Welsh Ministers

26 February 2026

Regulation 3

Schedule Purity criteria for magnesium L-threonate monohydrate

| Magnesium L-threonate monohydrate | |
| --- | |
| (1) The number assigned to this substance by the Chemical Abstracts Service (www.cas.org/cas-data/cas-registry). | |
| (2) The dalton, or unified atomic mass unit, is a unit of mass defined as one twelfth of the mass of an unbound neutral atom of carbon-12 in its nuclear and electronic ground state and at rest. | |
| (3) United States Pharmacopeia. | |
| Synonym | Magnesium L-threonate |
| Definition | |
| Chemical name | Magnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate |
| Chemical formula | C 8 H 16 MgO 11 |
| CAS number | 500304-76-7 (1) |
| Molecular weight | 312.51 Da (2) |
| Colour (solid) | White |
| Assay | Magnesium: 7.2 to 8.3%

L-threonate: 82 to 91% |
| Description | A water-soluble white powder which is manufactured via a chemical synthetic process. |
| Identification | |
| Solubility | Soluble in water at 1% concentration at 25℃ and that is clear in solution at 1% concentration. |
| pH (USP (3) (1% in H 2 O)) | 5.8 to 7.0 |
| Purity | |
| Loss on drying | Not more than 5.0% (105℃/4 hours) |
| Oxalic acid/oxalate | Not more than 0.5% (as oxalic acid) |
| Arsenic | Not more than 1 mg/kg |
| Lead | Not more than 0.5 mg/kg |
| Cadmium | Not more than 0.2 mg/kg |
| Mercury | Not more than 0.1 mg/kg |

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations are made using powers set out in regulations 2(2), 3 and 5(1) of the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/651) (“ the 2019 Regulations ”).

Regulation 5 of the Food Supplements (Wales) Regulations 2003 (S.I. 2003/1719 (W. 186)) prohibits the sale of food supplements manufactured using vitamins or minerals unless that vitamin or mineral is—

(a) listed in Schedule 1 to the 2019 Regulations;

(b) in a form which is listed in Schedule 2 to the 2019 Regulations and meets the relevant purity criteria.

The mineral, magnesium, is already listed in Schedule 1 to the 2019 Regulations. These Regulations—

(a) add the mineral form, magnesium L-threonate monohydrate (“the Substance”) to the list in Schedule 2 to the 2019 Regulations;

(b) set purity criteria for the Substance.

The Substance is also a novel food within the meaning of 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 (EUR 2015/2283) (“ the Novel Food Regulation ”).

The Welsh Ministers have determined the authorisation status of the Substance in relation to Wales in accordance with Article 12 of the Novel Food Regulation. Information about the authorisation is available on the list of novel foods maintained by the Food Standards Agency (Foss House, Kings Pool, 1-2 Peasholme Green, York, YO1 7PR) in accordance with Article 3B of the Novel Food Regulation.

The Welsh Ministers’ Code of Practice on the carrying out of Regulatory Impact Assessments was considered in relation to these Regulations. As a result, a regulatory impact assessment has been prepared as to the likely costs and benefits of complying with these Regulations. A copy can be obtained from the Public Health Directorate, Welsh Government, Cathays Park, Cardiff, CF10 3NQ and is published on www.gov.wales.

(1) S.I. 2019/651. The reference to “appropriate authority” in regulation 5(1) means, for regulations applying in relation to Wales, the Welsh Ministers (see regulation 5(4), to which there are amendments not relevant to these Regulations).

(2) EUR 2002/178, to which there are amendments not relevant to these Regulations.

(3) S.I. 2019/651. The reference in regulation 8(3) to the National Assembly for Wales now has effect as a reference to Senedd Cymru by virtue of section 150A(2) of the Government of Wales Act 2006 (c. 32). See also section 37G of the Legislation (Wales) Act 2019 (anaw 4) for provision about the procedure that applies to this instrument.

(4) S.I. 2019/651, amended by regulation 6(3)(b) of S.I. 2023/28 to add “magnesium citrate malate”; there are other amendments to Schedule 2 but none is relevant to these Regulations.

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