Update: Planned EU maximum levels for vitamins, minerals and trace elements
Maximum levels to be introduced by 2024
June 2024 (update). Currently, the European Commission is planning to introduce maximum levels in food supplements and fortified foods based on a re-evaluation of tolerable upper daily intakes (ULs) by the European Food Safety Authority (EFSA)[1]. The German Federal Institute for Risk Assessment (BfR) has already adjusted its recommended maximum levels for vitamin B6, vitamin D, selenium and folate/folic acid. However, EFSA's re-evaluation of the UL is not yet complete. We provide an up-to-date overview of the status quo.
Final Opinions for Vitamin B6, Vitamin D, Folic Acid and Selenium
Overview of the final EFSA opinions
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:
|
Vitamin, mineral, trace element |
UL for adults, pregnant & lactating women |
UL for infants & children |
|
Vitamin A |
3000 µg RE/day |
600-2600 µg RE/day |
|
Vitamin B6 |
12 mg/day |
2.2–2.5 mg/day (4–11 months) |
|
Vitamin D |
100 µg VDE/day |
50 µg VDE/day (1-10 years) |
|
Vitamin E |
300 mg/day* |
50 mg/day* (4-6 months) |
|
Iron |
40 mg/day** |
5 mg/day** (4-11 months) |
|
Folic acid/folate |
1000 µg/day |
200 µg/day (1-3 years) |
|
Selenium |
255 µg/day |
UL derived from adult value, allometric scaling (body weight0,75) |
*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, pregnant women, and breastfeeding women. For children, a daily intake between 5 mg and 35 mg is recommended[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].
Further EFSA drafts
- 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
|
Vitamin, mineral, trace element |
Maximum levels in food supplements |
| Vitamin B6 | 0.9 mg/day |
| Vitamin D | 20 µg/day |
| Folic acid/folate | 200 µg/day* |
| Selenium | 40 µg/day |
* Maximum level folic acid/folate in food supplements for reducing the risk of neural tube defects: 400 µg/day
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.
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:
|
Vitamin, mineral, trace element |
Maximum quantity proposal for a "saturated" market* |
Maximum quantity proposal for a "partially saturated" market** |
|
| Solid food | Solid food | Beverages | |
| Vitamin B6 | 0.27 mg/100g | 0.54 mg/100g | 0.14 mg/100ml |
| Selenium | 10 µg/100g | 24 µg/100g | 6 µg/100ml |
*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:
|
Food category |
Maximum quantities per 100g |
| Milk and dairy products, including cheese | 1.5 µg |
| Bread and cereal products (except pastries) | 5.0 µg |
| Spreadable fats and edible oils | 7.5 µg |
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.
Questions about the analysis of vitamins, minerals, and trace elements
The Eurofins Laboratories for Food and Feed Analysis in Germany are your competent partner for the analysis of vitamins, minerals and trace elements in food supplements, fortified foods, and other complex matrices. If you have any specific questions, please do not hesitate to contact your personal account manager or our experts.
References
[1] EFSA (2023): Dietary reference values
[2] European Commission (2023): Food safety – vitamins and minerals added to food (minimum and maximum levels)
[3] EFSA (2023): Scientific opinion on the tolerable upper intake level for vitamin B6
[4] EFSA (2023): Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate
[5] EFSA (2023): Scientific opinion on the tolerable upper intake level for folate
[6] EFSA (2023): Scientific opinion on the tolerable upper intake level for selenium
[7] EFSA (2023): Draft scientific opinion on the tolerable upper intake level for manganese (direct download link to the EFSA document)
[8] EFSA (2024): Scientific opinion on the tolerable upper intake level for preformed vitamin A and β-carotene
[9] EFSA (2024): Scientific opinion on the tolerable upper intake level for iron
[10] BfR (2024): Statement 008/2024, Update (2024): Proposed maximum levels for vitamin B6 in foods including food supplements (in german language)
[11] BfR (2024): Statement 007/2024, Update (2023): Proposed maximum levels for vitamin D in foods including food supplements (in german language)
[12] BfR (2024): Statement 010/2024, Update (2023): Proposed maximum levels for selenium in foods including food supplements (in german language)
[13] BfR (2024): Statement 009/2024, Update (2024): Proposed maximum levels for folic acid in foods including food supplements (in german language)
[14] EFSA (2024): Scientific opinion on the Tolerable Upper Intake Level for vitamin E
