Magtein® wins EU novel food approval – plus exclusivity for five years

Upon an application by North American ingredient supplier AIDP, the European Union has officially authorized the use of magnesium L-threonate as a novel food which means that it is now fully approved for inclusion in products sold to consumers throughout the EU, offering a new and highly bioavailable option for magnesium supplementation.

EU consumers can now experience the clinically proven benefits that are unique to magnesium L-threonate. Image credit: (Photo credit: GaudiLab/Shutterstock.com)

In a significant move, the European Union determined that use of the proprietary data on which the authorization 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 authorized to market magnesium L-threonate in the EU for a period of 5 years from 7 November 2024, unless a subsequent applicant obtains an authorization 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. Any company currently selling magnesium L-threonate as a novel food in the EU without a license should contact ThreoTech and immediately stop selling the unlicensed products.

Edward Lee, ThreoTech CEO, commented: “Novel food authorization 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.”

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.