Magtein receives EU clearance as a new food and five years of exclusivity
Magtein EU novel food approval.
Image credit GaudiLab –Shutterstock.com
The European Union has formally authorised the use of magnesium L-threonate as a novel food, meaning that it is now completely permitted for inclusion in products sold to consumers throughout the EU.
This provides a new and highly bioavailable option for magnesium supplementation, following an application by North American ingredient supplier AIDP.
In a significant move, the European Union determined that use of the proprietary data on which the authorisation depended is exclusive to AIDP. Only AIDP, respectively its partner company and licensee ThreoTech, which markets magnesium L-threonate under the trademark Magtein and sublicensees are authorised to market magnesium L-threonate in the EU for a period of five years from 7 November 2024, unless a subsequent applicant obtains an authorisation without reference to the protected proprietary data.
Under this exclusivity, the marketing of magnesium L-threonate as a novel food in the EU will require prior approval by AIDP, and, as its licensee, ThreoTech. Any company wishing to market magnesium L-threonate during the exclusivity period will be required to take a license from ThreoTech and source the magnesium L-threonate from ThreoTech.
ThreoTech has retained Herbert Smith Freehills, a leading global law firm, to pursue companies in the EU that infringe the exclusivity granted by the novel food approval. ThreoTech urged any company currently selling magnesium L-threonate as a novel food in the EU without a license should contact it and immediately stop selling the unlicensed products.
Edward Lee, ThreoTech CEO, noted that achieving novel food authorisation for Magtein means EU consumers can now, for the first time, experience the clinically proven benefits that are unique to magnesium L-threonate.
In addition, the five-year period of exclusivity granted to AIDP, and its licensee ThreoTech, offers added reassurance to consumers, manufacturers, and brands that the magnesium L-threonate sourced through ThreoTech is guaranteed to be safe, authentic, and of the highest quality,” he said.
As well as declaring Magtein magnesium L-threonate to be safe, the EU also confirmed it to be a bioavailable source of magnesium. The official notice of novel food approval (Commission Regulation 2024/2694), can be viewed in full here. In addition, a corrigendum specifying maximum levels as elemental magnesium from magnesium L-threonate can be found here.
Magtein is suitable for use in a wide range of products, including capsules, RTD beverages, snack bars, gummies, gels, and powders.
