Planned EU maximum levels for vitamins, minerals and trace elements

Overview of the final re-evaluations of maximum levels by EFSA

EFSA is currently re-evaluating the ULs for selected vitamins, minerals and trace elements in food supplements and fortified foods. Final opinions are available for vitamin B6, vitamin D, folic acid/folate and selenium

*UL apply to all stereoisomeric forms of alpha-tocopherol and do not apply to persons receiving anticoagulant or antiplatelet medications, secondary prevention of cardiovascular disease, or patients with vitamin K malabsorption syndromes
**Recommended safe daily iron intake, no UL value

• For vitamin A, the EFSA recommends that the current UL of 3000 µg retinol equivalents (RE)/day for adults should remain unchanged. For children, the EFSA proposes an UL of between 600 and 2600 µg RE/day, depending on age. It is currently not possible to set a UL for ß-carotene due to missing and insufficient data^[8].
• EFSA recommends a reduction of the UL value for vitamin B6 from 25 mg/day to 12 mg/day and even lower UL values for infants and children. The reason for this is the possible occurrence of peripheral neuropathy with excessive intake of vitamin B6 observed in studies^[3].
• The proposed ULs for vitamin D apply to intakes of ergocalciferol, cholecalciferol and calcidiol monohydrate^[4].
• For vitamin E, EFSA recommends that the current UL of 300 mg/day for adults, including pregnant and breastfeeding women should remain unchanged. For children, age-appropriate ULs between 50 and 260 mg/day are recommended. Exceptions are people with medical conditions and those taking certain medications. They should only take vitamin E under medical supervision. Overall, the ULs apply to all stereoisomeric forms of alpha-tocopherol^[14]. 
• For iron, the EFSA was only able to show a dose-response relationship for one of the examined endpoints (black stool), which was not reported to be harmful. Therefore, EFSA could not establish a UL for iron. Based on the results, EFSA recommends a safe daily intake of 40 mg of iron for adults^[9].
• There are no changes to the existing UL for folic acid/folate. The recommended ULs for folate apply to the combined intake of folic acid, 5-methyltetrahydrofolic acid glucosamine and L-5-methyltetrahydrofolic acid calcium salts under their respective approved conditions of use^[5].
• In its final opinion on selenium, EFSA recommends lowering the UL value from 300 µg/day to 255 µg/day^[6].

A draft re-evaluation is available for manganese, recommending a UL of 8 mg/day for adults, pregnant and breastfeeding women^[7].

Overview of BfR maximum quantity proposals for food supplements

Based on the EFSA assessments, the BfR has adjusted its recommended maximum levels for vitamin B6^[10], vitamin D^[11], selenium^[12] and folic acid/­folate^[13] in food supplements.

* Maximum level folic acid/folate in food supplements for reducing the risk of neural tube defects: 400 µg/day

Overview of BfR maximum quantity proposals for fortified foods

The BfR has also adapted its proposals for maximum levels for fortified foods following EFSA's assessments:

*30% of the daily energy intake through fortified foods
**15% of the daily energy intake from fortified foods (only some of the fortifiable foods are fortified)

The BfR recommends different values for vitamin D depending on the food category:

For folic acid and other approved sources of folate, the BfR recommends maximum levels of 30-98.5 µg/100g for solid foods and 15-26 µg/100ml for beverages^[13]. The values vary according to the options defined by different market assumptions. The exact options and the corresponding maximum levels proposed for folic acid/folate can be found in the BfR statement 009/2024 (in German).

Get in touch

Would you like to find out more about our testing solutions, or do you need tailored analytical support? Contact us today to get in touch with our experts.

Contact