Magnesium L-threonate gains EU novel food status with exclusive market rights
A proprietary form of magnesium L-threonate has achieved novel food authorisation from the European Union, marking a significant development in bioavailable magnesium supplementation. North American ingredient supplier AIDP and its licensee ThreoTech have secured exclusive EU marketing rights for five years, establishing new regulatory precedent for proprietary ingredient protection in the novel foods category.
The European Union has granted novel food authorisation to magnesium L-threonate, specifically approving its use in consumer products throughout the EU market. The authorisation, detailed in Commission Regulation 2024/2694, provides AIDP and its partner ThreoTech with exclusive marketing rights until November 2029.
The approval’s exclusivity clause represents a notable development in novel food regulation, protecting the proprietary data underlying the authorisation. This protection effectively restricts EU market access to AIDP’s branded form, Magtein®, and its licensed derivatives through ThreoTech.
Technical specifications and application scope
The EU assessment confirmed magnesium L-threonate’s safety profile and validated its bioavailability as a magnesium source. A supplementary corrigendum establishes precise maximum levels for elemental magnesium derived from the L-threonate form, providing manufacturers with essential formulation parameters.
Magtein is suitable for use in a wide range of products, including capsules, RTD beverages, snack bars, gummies, gels, and powders.
The ingredient has demonstrated compatibility with multiple delivery formats, including solid dose forms, ready-to-drink beverages, confectionery matrices, and powder systems. This versatility enables broad application across the functional food and supplement categories.
Market access and compliance framework
ThreoTech, operating as AIDP’s exclusive global ingredient supplier and patent licensee, has implemented a structured licensing programme for EU market access. The company has retained Herbert Smith Freehills to manage compliance and enforce exclusivity rights.
Edward Lee, ThreoTech CEO, explained the significance: “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.”
Technical validation and market implications
The authorisation establishes magnesium L-threonate as a validated ingredient within the EU’s novel food framework. This regulatory achievement provides manufacturers with a new option for magnesium fortification, supported by bioavailability data and defined safety parameters.
Companies currently marketing magnesium L-threonate products in the EU must cease distribution unless licensed through ThreoTech. This requirement establishes a controlled supply chain that ensures ingredient authenticity and quality consistency.
This is a significant development in magnesium supplementation technology while demonstrating the EU’s capacity to protect proprietary research data through novel food regulations. This precedent may influence future novel food applications where exclusive rights are sought based on proprietary safety and efficacy data.
- 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.
- For information about seeking a license, contact:
ThreoTech – hello@threotech.com
