概括
On October 18, 2024, the European Commission published Commission Implementing Regulation (EU) 2024/2694, officially authorizing the use of magnesium L-threonate as a novel food ingredient in food supplements intended exclusively for adults. This new regulation permits the use of magnesium L-threonate in food supplements across the EU, with a specified maximum intake of 250 mg per day and with labelling requirements that exclude pregnant and lactating women from its intended audience.
Key Points of the Regulation
- Authorized Use: Magnesium L-threonate is approved solely for adult food supplements with a maximum dose of 250 mg/day.
- Labelling Requirements: Labels must specify “Magnesium L-threonate” and state that the product is intended only for adults, excluding pregnant and lactating women.
- Specifications Compliance: All products must adhere to the specifications outlined in the Annex of the regulation.
- Market Exclusivity: AIDP Inc., the applicant company, holds exclusive rights to market magnesium L-threonate in the EU for five years starting November 7, 2024, with data protection rights as per Article 26(2) of Regulation (EU) 2015/2283.
- EFSA Assessment: The European Food Safety Authority (EFSA) has reviewed magnesium L-threonate and determined it is safe under the specified conditions of use, offering a bioavailable source of magnesium.
Implementation and Deadlines
This regulation will take effect 20 days following its publication in the Official Journal of the European Union.
