6100 mg Dosage Warning! EU Safety Panel Flags Serious Risks for Magnesium Orotate Dihydrate

The European Food Safety Authority (EFSA) has issued a cautionary scientific opinion on magnesium orotate dihydrate, a compound proposed for use in food supplements at doses up to 6100 mg per day for adults. The expert panel, after thorough evaluation, concluded that the safety of this novel food ingredient could not be confirmed under the suggested usage levels.

At the proposed intake, the amount of supplemental magnesium (400 mg/day) far exceeds the established upper limit of 250 mg/day, raising concerns about adverse health effects. Even more troubling, the intake of orotic acid from this compound reaches around 5000 mg/day, with animal studies indicating potential tumor-promoting risks. The calculated safety margin for orotic acid exposure is only 0.7—well below the acceptable threshold.

The panel also highlighted that the applicant failed to provide critical toxicological data to address these safety concerns. No assessment was made comparing the bioavailability of magnesium from this source to that of natural sources. As a result, EFSA concluded that the safety of magnesium orotate dihydrate as a novel food cannot be established under the current usage proposal.

Consumers and manufacturers should pay close attention to these findings, as regulatory scrutiny over novel supplements continues to tighten across Europe.