IN Brief:
- Magnesium L-threonate monohydrate has been authorised in Great Britain as a novel food for adult food supplements.
- The terms set a maximum intake of 3g per day and exclude under-18s, pregnant women, and lactating women.
- The authorisation carries five years of data protection linked to the applicant dossier.
Magtein, the branded form of magnesium L-threonate monohydrate, has been authorised in Great Britain as a novel food for use in food supplements. The decision opens the market under tightly defined conditions, giving the ingredient a formal regulatory route in England, Scotland, and Wales after several years of assessment.
The authorisation is narrower than some of the broader commercial discussion around the ingredient. In Great Britain, the approved use is in food supplements only. It applies to adults aged 18 and above, and excludes pregnant and lactating women. The maximum permitted intake is 3g per day, and labels must identify the ingredient as magnesium L-threonate while also stating that the supplement should not be consumed by children under 18, pregnant women, or lactating women.
The regulatory file has been moving for some time. AIDP submitted its application to the Food Standards Agency and Food Standards Scotland in 2021. The Advisory Committee on Novel Foods and Processes later concluded that magnesium L-threonate monohydrate was safe under the proposed conditions of use and not nutritionally disadvantageous, clearing the way for ministers in England, Scotland, and Wales to take the authorisation decision.
The FSA’s risk management documents set out the product as a replacement magnesium source in supplements rather than an additional source layered on top of existing magnesium use. Under the authorised conditions, the 3g daily maximum provides up to 249mg of magnesium and up to 2,730mg of L-threonate. The dossier also specifies the ingredient as a water-soluble white powder produced through a chemical synthetic process.
The decision broadly aligns Great Britain with the position already taken in the EU. Magnesium L-threonate was authorised there in 2024, and the FSA’s consultation papers said there was no significant divergence between the proposed Great Britain terms and the EU approach. Northern Ireland already sits within the EU framework for this category, so the Great Britain move narrows the regulatory gap across the UK market.
The other important detail is exclusivity. The authorisation carries five years of data protection tied to the scientific evidence submitted with the application. In practice, that limits early market access to the applicant and authorised partners unless another business secures a separate authorisation without relying on the protected dossier.
For the supplements market, that creates a clearer regulatory line. Magnesium L-threonate now has defined conditions of use in Great Britain, but it also arrives with limits on who can sell it, how it can be labelled, and exactly where it can be used.
