Regulation
EFSA upper levels for vitamins and minerals
EFSA's tolerable upper intake levels show the highest long-term daily intake not expected to harm health. They are scientific reference values, not legal limits: the EU has no harmonised maximum strength for food supplements.
What an upper level is
EFSA defines the tolerable upper intake level (UL) as "the maximum level of total chronic daily intake of a nutrient (from all dietary sources) which is not expected to pose a risk of adverse health effects to humans." It is an intake over the long term, not a dose to aim for, and it is not a statement about any single product.
Most ULs cover total intake from food and supplements together. Magnesium and folate are the main exceptions: their ULs cover only supplemental or added forms. The values below reproduce EFSA's Overview on Tolerable Upper Intake Levels, version 11 (August 2025), the latest version we found, with the later vitamin E infant values added. Age bands differ between some nutrients.
Upper levels for minerals
| Nutrient | Adults (per day) | Children and adolescents | Pregnancy / lactation |
|---|---|---|---|
| Boron | 10 mg | 1–3 y 3; 4–6 y 4; 7–10 y 5; 11–14 y 7; 15–17 y 9 | 10 / 10 mg |
| Calcium | 2,500 mg | No adequate data to derive a UL | 2,500 / 2,500 mg |
| Copper | 5 mg | 1–3 y 1; 4–6 y 2; 7–10 y 3; 11–14 y 4; 15–17 y 4 | Not defined |
| Fluoride | Not defined (see safe levels) | Under 1 y 1.0; 1–3 y 1.6; 4–8 y 2.0 | Not defined |
| Iodine | 600 µg | 1–3 y 200; 4–6 y 250; 7–10 y 300; 11–14 y 450; 15–17 y 500 | 600 / 600 µg |
| Magnesium | 250 mg | 1–3 y not defined; 4–17 y 250 | 250 / 250 mg |
| Molybdenum | 0.6 mg | 1–3 y 0.1; 4–6 y 0.2; 7–10 y 0.25; 11–14 y 0.4; 15–17 y 0.5 | 0.6 / 0.6 mg |
| Selenium | 255 µg | 4–6 mo 45; 7–11 mo 55; 1–3 y 70; 4–6 y 95; 7–10 y 130; 11–14 y 180; 15–17 y 230 | 255 / 255 µg |
| Zinc | 25 mg | 1–3 y 7; 4–6 y 10; 7–10 y 13; 11–14 y 18; 15–17 y 22 | 25 / 25 mg |
- Boron: boric acid and borates only.
- Calcium: diet plus supplements.
- Copper: in 2023 EFSA also set an acceptable daily intake of 0.07 mg/kg body weight.
- Fluoride: all oral exposure.
- Magnesium: supplemental forms only, meaning readily dissociable salts and compounds such as magnesium oxide in supplements, water or added to foods. Magnesium naturally in food is excluded.
- Selenium: all dietary sources.
Upper levels for vitamins
| Nutrient | Adults (per day) | Children and adolescents | Pregnancy / lactation |
|---|---|---|---|
| Folate | 1,000 µg | 4–6 mo 200; 7–11 mo 200; 1–3 y 200; 4–6 y 300; 7–10 y 400; 11–14 y 600; 15–17 y 800 | 1,000 / 1,000 µg |
| Niacin as nicotinamide | 900 mg | 1–3 y 150; 4–6 y 220; 7–10 y 350; 11–14 y 500; 15–17 y 700 | Inadequate data |
| Niacin as nicotinic acid | 10 mg | 1–3 y 2; 4–6 y 3; 7–10 y 4; 11–14 y 6; 15–17 y 8 | Inadequate data |
| Vitamin A | 3,000 µg RE | 4–6 mo 600; 7–11 mo 600; 1–3 y 800; 4–6 y 1,100; 7–10 y 1,500; 11–14 y 2,000; 15–17 y 2,600 | 3,000 / 3,000 µg RE |
| Vitamin B6 | 12 mg | 4–6 mo 2.2; 7–11 mo 2.5; 1–3 y 3.2; 4–6 y 4.5; 7–10 y 6.1; 11–14 y 8.6; 15–17 y 10.7 | 12 / 12 mg |
| Vitamin D | 100 µg | 0–6 mo 25; 7–11 mo 35; 1–3 y 50; 4–6 y 50; 7–10 y 50; 11–14 y 100; 15–17 y 100 | 100 / 100 µg |
| Vitamin E | 300 mg | 4–6 mo 50; 7–11 mo 60; 1–3 y 100; 4–6 y 120; 7–10 y 160; 11–14 y 220; 15–17 y 260 | 300 / 300 mg |
- Folate: added forms only, meaning folic acid and the authorised methyltetrahydrofolate salts. Folate naturally in food is excluded.
- Niacin as nicotinic acid: free nicotinic acid.
- Vitamin A: preformed vitamin A only (retinol and retinyl esters).
- Vitamin B6: all dietary sources and vitamers.
- Vitamin D: all sources. 1 µg = 40 IU.
- Vitamin E: infant values come from EFSA's 2024 opinion. The levels do not apply to people on anticoagulant or antiplatelet medication.
Safe levels of intake: iron, manganese, fluoride
Where the data could not support a UL, EFSA set safe levels of intake instead. EFSA notes that these have more limited uses than ULs: "intakes above the safe levels of intake do not necessarily mean that there is a risk of adverse effects". The iron figures do not apply to people receiving iron under medical supervision.
| Nutrient | Adults (per day) | Children and adolescents | Pregnancy / lactation |
|---|---|---|---|
| Iron | 40 mg | 4–6 mo 5; 7–11 mo 5; 1–3 y 10; 4–6 y 15; 7–10 y 20; 11–14 y 30; 15–17 y 35 | 40 / 40 mg |
| Manganese | 8 mg | 4–12 mo 2; 1–2 y 4; 3–6 y 5; 7–13 y 6; 14–17 y 7 | 8 / 8 mg |
| Fluoride | 3.3 mg | 9–17 y 3.3 | 3.3 / 3.3 mg |
- Iron: total intake from age 1. Under 1 year the figure covers supplements and fortified foods only, not infant formula.
- Manganese: total intake from all dietary sources.
- Fluoride: all oral sources. Set for pregnant women to protect the fetus.
Nutrients with no upper level
A missing UL does not mean that any amount is safe. It usually means the data were not good enough to set a number.
| Nutrient | EFSA or SCF position |
|---|---|
| Vitamin C | No adequate data to derive a UL. Supplemental doses up to about 1 g/day were not associated with adverse gastrointestinal effects; such effects may occur at 3–4 g/day |
| Vitamin B12 | No defined adverse effects |
| Biotin, thiamin (B1), riboflavin (B2), pantothenic acid | No adequate data to derive a UL |
| Vitamin K | No adequate data to derive a UL. No adverse effects up to 10 mg/day of phylloquinone for limited periods |
| Potassium | No adequate data to derive a UL. About 3 g/day long-term as potassium chloride showed no adverse effects; 5–7 g/day affected heart function in a few cases |
| Phosphorus | No adequate data to derive a UL. Mild gastrointestinal symptoms above 750 mg/day from supplements |
| Chromium (III) | No adequate data to derive a UL. No adverse effects up to 1 mg/day; this does not apply to chromium picolinate |
| β-carotene | No UL or safe level could be set. Smokers should avoid supplements containing it |
| EPA, DHA and DPA | No adequate data to derive a UL. See the omega-3 entry for EFSA's safety statements |
| Chloride, nickel, silicon, sodium, tin, vanadium | No adequate data to derive a UL |
Is there an EU maximum strength for supplements?
No. Article 5 of Directive 2002/46/EC says maximum amounts shall be set, taking upper safe levels into account, but none has been adopted. EFSA's food supplements page, last reviewed in October 2026, says there are "at present no binding maximum and minimum levels", and the Commission says no proposal has yet been presented. Until EU limits exist, Article 11(2) leaves national provisions in place, so the legal maximum depends on the country and on how a product is classified. A high-dose product can also be a medicine rather than a supplement.
The file is still open. The Commission's Have Your Say portal lists a planned regulation on minimum and maximum amounts (initiative 12750), with adoption pencilled in for the first quarter of 2028. A public consultation was planned for the third quarter of 2026, but the portal showed none published when this page was reviewed. In December 2025 Germany and sixteen other Member States asked for limits to be set in 2026 (Council note 15839/25).
National limits vary widely
These examples show the spread for a daily dose. France and Belgium set binding figures; the German figures are non-binding recommendations from the Federal Institute for Risk Assessment (BfR), for people over 15. Italy publishes its own values, which we could not read at source and so do not reproduce.
| Nutrient | France (2006 arrêté) | Belgium (2021 royal decree) | Germany (BfR 2021) |
|---|---|---|---|
| Vitamin D | 5 µg | 75 µg | 20 µg |
| Magnesium | 300 mg | 450 mg | 250 mg |
| Zinc | 15 mg | 22.5 mg | 6.5 mg |
| Iron | 14 mg | 45 mg | 6 mg |
None of these is an EU limit. The German iron figure comes with a caution: men, post-menopausal women and pregnant women should consult a doctor first. The French figures are those of the Arrêté of 9 May 2006, Annex III.
Frequently asked questions
What is the EFSA upper limit for magnesium supplements?
250 mg per day of supplemental magnesium for adults and children from 4 years, covering readily dissociable salts and compounds such as magnesium oxide in supplements, water or added to foods. Magnesium naturally present in food is not included.
What is the EFSA upper level for zinc?
25 mg per day for adults, including during pregnancy and lactation, from all sources. It is lower for children, from 7 mg at ages 1 to 3 to 22 mg at ages 15 to 17.
What is the upper level for vitamin D in children?
EFSA sets 25 µg per day up to 6 months, 35 µg at 7 to 11 months, 50 µg from 1 to 10 years and 100 µg from 11 years. These are limits on total intake, not recommended doses.
Does vitamin C have an upper level?
No. EFSA found insufficient data to set one, while noting that supplemental doses up to about 1 g per day were not associated with adverse gastrointestinal effects and that such effects may occur at 3 to 4 g per day.
Is the EFSA upper level a legal limit?
No. It is a scientific reference value. The EU has not adopted harmonised maximum amounts for food supplements, so limits are set nationally.
References & further reading
- EFSA, Overview on Tolerable Upper Intake Levels, version 11, August 2025: efsa.europa.eu.
- EFSA, Tolerable upper intake levels for vitamins and minerals (2006 compilation): efsa.europa.eu.
- EFSA NDA Panel, vitamin E opinion, 2024: EFSA Journal via PMC.
- EFSA NDA Panel, iron opinion, 2024: EFSA Journal via PMC.
- EFSA, food supplements topic page: efsa.europa.eu.
- European Commission, food supplements: food.ec.europa.eu.
- European Commission, Have Your Say initiative 12750: ec.europa.eu.
- Council of the European Union, note 15839/25: data.consilium.europa.eu.
- France, Arrêté of 9 May 2006 on nutrients in food supplements: legifrance.gouv.fr.
- Belgium, Royal Decree of 30 May 2021: ejustice.just.fgov.be.
- BfR, recommended maximum levels for vitamins and minerals (2021): bfr.bund.de.
Last reviewed: November 2026.