Published on July. 23, the European Commission updated Annex II to Directive 2002/46/EC in the Food Supplements Directive, listing the vitamin and mineral substances which may be used in the manufacture of food supplements, to include Magnesium L-threonate.
This is the final step in market authorization after the European Food Safety Authority (EFSA) gave a positive safety assessment and it gained novel food approval in October 2024. North American distributor Magtein secured exclusive rights to sell the compound in the EU market for five years.
The proposed conditions of use limit magnesium intake from this source to a maximum of 250 mg per day, for adults only, and explicitly excluding pregnant and lactating women.
Magnesium Orotate Dihydrate fails novel food application
EFSA published its opinion on Magnesium Orotate Dihydrate on July. 10, asserting the compound is not approved for use in food supplements in Europe under proposed conditions of use.
The scientific opinion concluded the safety of the ingredient (considered a novel food because it was not widely consumed in the EU before May 1997) cannot be established under the intended use—at levels delivering up to 400 mg of magnesium and approximately 5000 mg of orotic acid per day.
The authority deemed that this would significantly exceed the tolerable upper intake level of 250 mg/day for supplemental magnesium. It further noted concerns about tumour-promoting effects of orotic acid observed in animal studies, and lack of new toxicological data to address these concerns.
EFSA did not assess lower doses or provide a threshold below which magnesium orotate might be considered safe. Any company wishing to use this ingredient in supplements sold in Europe therefore need to submit new toxicological data and request a fresh safety evaluation from EFSA for novel food authorization.
Magnesium orotate, a compound of magnesium and orotic acid, is less widely used than forms.
Different types of magnesium
Magnesium comes in multiple forms, with types differing in absorption rate and bioavailability.
- Magnesium glycinate is often used for promoting sleep, reducing stress, and relaxing muscles
- Magnesium citrate and magnesium oxide are both used to relieve mild constipation
- Magnesium malate may help boost energy and ease muscle fatigue
- Magnesium L-threonate targets the brain, improving memory and cognitive function
- Magnesium taurate can support heart health and maintains healthy blood pressure
- Magnesium chloride provides good absorption for overall supplementation.
Magnesium trends
In Europe, magnesium continues to maintain its on-trend position due to its versatility, Nick Morgan, managing director of Nutrition Integrated, recently told NutraIngredients, with many companies incorporating magnesium for sleep and other products.
“Magnesium is a really good example of how a mineral that we’ve known for so long can continue to be exciting when positioned really well,” he said, adding that while it is well-known for sports recovery, it is increasingly gaining attention for sleep and calmness.
According to Laurentia Guesman, director of brand management at ThreoTech, the manufacturer and marketer of Magtein, its magnesium is now a top-trending active ingredient in the United States, particularly in mineral, cognition, mental health and sleep products.
“The brain health segment has diversified and expanded in the last few years into a broader category of mental health, which includes memory and focus, mood and stress and even sleep,” she told NI.
As this segment expands, older populations are increasingly choosing products for memory and focus, while younger consumers prefer those for mood and stress, Guesman noted.
“As the brain is the control center for many vital functions and mental health feelings, younger consumers are looking to incorporate these products to address more immediate concerns vs. long term concerns.”
