The Food Supplements Purity Criteria (Magnesium L-threonate monohydrate) (England) Regulations 2026
- Department: Department of Health and Social Care
Established mandatory chemical purity standards and identification criteria for magnesium L-threonate monohydrate used in food supplements in England.
These Regulations establish the statutory purity criteria for magnesium L-threonate monohydrate when used as a mineral source in food supplements.
The Secretary of State for Health and Social Care mandates that this substance must meet specific chemical identities, assay percentages for magnesium and L-threonate, and maximum limits for impurities like arsenic, lead, and oxalic acid.
These requirements apply to any person or business producing or marketing this substance for food supplement use within England.
Arguments For
The Secretary of State asserts that the regulations are made in accordance with the Nutrition (Amendment etc.) (EU Exit) Regulations 2019, which allow for the setting of purity criteria for substances used in food supplements.
The document states that an open and transparent consultation was conducted in accordance with Article 9 of Regulation (EC) No 178/2002 to ensure food safety principles were met.
The explanatory note indicates that no significant impact on the private, voluntary, or public sector is foreseen, suggesting the measures are not expected to impose substantial new burdens.
Arguments Against
Manufacturers may need to adjust quality control processes to ensure compliance with the specific limits for heavy metals, such as mercury (0.1 ppm) and lead (0.5 ppm).
Legal stakeholders might note that the regulations apply only to England, potentially creating different regulatory requirements within the United Kingdom's internal market for food supplements.
Food producers must adhere to the specific chemical synthetic process description and pH ranges (5.8 to 7.0) defined in the Schedule, which could limit alternative manufacturing methods.
Citation, commencement, extent and application
- -(1) These Regulations may be cited as the Food Supplements Purity Criteria (Magnesium L-threonate monohydrate) (England) Regulations 2026 and come into force on 13th August 2026.
- (2) These Regulations extend to England and Wales.
- (3) These Regulations apply to England only.
This section provides the official name of the statutory instrument and sets the date it becomes legally enforceable as 13 August 2026.
It specifies that while the legal reach of the document covers both England and Wales, the actual regulatory requirements apply only to activities within England.
Purity criteria for magnesium L-threonate monohydrate
- The purity criteria for magnesium L-threonate monohydrate are set out in the Schedule to these Regulations.
This provision gives legal effect to the detailed technical standards listed in the appended Schedule.
It mandates that magnesium L-threonate monohydrate must satisfy those specific criteria to be considered compliant with food law in England.
Schedule
Regulation 2
PURITY CRITERIA FOR MAGNESIUM L-THREONATE MONOHYDRATE
| Synonym | Magnesium L-threonate | |---|---| | Definition | | | Chemical name | Magnesium (2R,3S)-2,3,4-trihydroxybutanoate monohydrate | | CAS number | 500304-76-7 | | Chemical formula | C 8 H 16 MgO 11 | | Molecular weight | 312.51 Da | | 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 (1% in H#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 ppm | | Lead | Not more than 0.5 ppm | | Cadmium | Not more than 0.2 ppm | | Mercury | Not more than 0.1 ppm |
The Schedule defines the exact chemical and physical properties required for the substance, including its molecular weight, CAS number, and a requirement that it be produced via chemical synthesis.
It sets quantitative limits on the presence of heavy metals (arsenic, lead, cadmium, mercury) and other impurities like oxalic acid.
Additionally, it dictates the acceptable range for magnesium and L-threonate content within the final product.
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