Are there EU-wide maximum levels?
No harmonised EU maximum levels for vitamins and minerals in food supplements are currently in force. Each member state applies its own limits, or none. Labels must also state amounts in the units of EU law, so IU to mcg conversion (vitamin D) and IU to mg conversion (vitamin E) are routine. This guide explains how the rules are built, where each figure comes from, and what to check before launching in a new market.
What the food supplements directive 2002/46/EC provides
Directive 2002/46/EC is the framework act for food supplements in the EU. Annex I lists the vitamins and minerals that may be used. Annex II lists the chemical forms of those nutrients that may be used. Our guide to permitted vitamin and mineral forms covers Annex II in detail.
Article 5 of the Directive sets out how maximum amounts are to be fixed. The criteria are upper safe levels from scientific risk assessment, intake from other dietary sources, and population reference intakes. Article 5 gives the Commission the task of setting these amounts at EU level. That step has not been completed, so the gap is filled nationally.
Article 5 also provides for minimum amounts to be set, to ensure that significant amounts of the nutrient are present. Minimum amounts are likewise not harmonised for food supplements. Check the national position on minimums alongside the maximums.
How national maximum levels work
Member states handle maximum levels in different ways. The differences are structural, not only numerical.
- Binding limits. Some countries set maximum amounts per daily portion in national legislation.
- Guidance values. Some publish non-binding reference values that the authority uses when assessing products.
- Case-by-case assessment. Some have no fixed list and assess notified products individually.
- No specific limit. For some nutrients, a country may set no maximum at all.
Limits are normally expressed as the vitamin or the elemental mineral, not as the salt. A limit for magnesium applies to magnesium, whatever form supplies it. Use the elemental content calculator to work back from a label claim to the quantity of salt.
The basis of the limit also varies. Most authorities refer to the recommended daily portion on the label. Confirm whether the figure includes overages and how analytical tolerances are treated.
In principle, mutual recognition allows a product lawfully marketed in one member state to be marketed in another. A member state may still restrict it on public-health grounds. It does not remove the need to check each target market.
Notification before placing on the market
Article 10 of Directive 2002/46/EC lets member states require notification when a supplement is first placed on their market. Where it applies, the manufacturer or the person placing the product on the market sends a model of the label to the competent authority. Procedures, fees and timing differ by country. Some authorities use notification to check amounts against their national limits.
Converting IU to mcg and mg for the label
Article 8 of the Directive requires the amount of each vitamin and mineral to be declared in numerical form, using the units listed in Annex I. For vitamin D the unit is micrograms (µg). For vitamin E it is milligrams of alpha-tocopherol equivalents. For vitamin A it is micrograms of retinol equivalents.
Raw-material specifications and older formulas often use IU. The conversion factor is specific to each vitamin.
| Vitamin | EU label unit | What decides the conversion |
|---|---|---|
| Vitamin D | µg | Fixed factor per vitamin; same for D2 and D3 |
| Vitamin E | mg alpha-tocopherol equivalents | Depends on the form: natural or synthetic, free or esterified |
| Vitamin A | µg retinol equivalents | Depends on the form: retinol, retinyl esters or carotenoids |
The vitamin unit converter applies the correct factors. For the forms themselves, see the guides to vitamin D forms, vitamin E forms and vitamin A forms.
National maximum levels use the same units. Convert before comparing. Whether an IU value may also appear on the label is a national labelling question.
Ingredient concentration adds a second step. Vitamin D, for example, is supplied as diluted forms of cholecalciferol rather than the pure substance. The specification sheet and certificate of analysis state the content per gram. SoleChem sends both with its quote, so the arithmetic can use the actual lot data.
Fortified foods and other substances
Regulation (EC) No 1925/2006 governs vitamins and minerals added to ordinary foods. It also provides for maximum amounts to be set at EU level, and these are not harmonised either. A product sold as a food supplement falls under Directive 2002/46/EC, not this Regulation, for its nutrient content.
The positive lists in Directive 2002/46/EC cover only vitamins and minerals. Amino acids, botanicals and other substances in supplements are largely governed by national rules, alongside the EU rules below. Limits, permitted lists and conditions for these differ widely by member state.
Article 8 of Regulation (EC) No 1925/2006 allows the EU to prohibit, restrict or place under scrutiny specific substances. Measures adopted appear in Annex III of that Regulation. These apply across the EU.
Any ingredient without a history of significant consumption in the EU before 15 May 1997 may be a novel food. Under the novel food regulation, Regulation (EU) 2015/2283, it then needs authorisation. Authorised novel foods and their conditions of use, which can include maximum levels, are in the Union list in Implementing Regulation (EU) 2017/2470. See our guide to novel food status.
What a manufacturer must do
- List every member state where the product will be sold.
- Obtain each country’s current maximum levels from its competent authority, and note whether they are binding or guidance.
- Confirm each nutrient form is listed in Annex II of Directive 2002/46/EC.
- Check novel food status and any Annex III restriction for every non-vitamin, non-mineral ingredient.
- Express all amounts in Annex I units, per recommended daily portion.
- Check how the authority treats overages and tolerances against the maximum. The overage calculator helps plan the formulated amount.
- Complete national notification where required.
Label content is covered in labelling a food supplement in the EU. General food labelling rules sit in Regulation (EU) No 1169/2011.
Where to check
Check EU acts in their consolidated version on EUR-Lex. Amendments to the annexes are frequent. National maximum levels are published by each member state’s competent authority, usually the health ministry or food safety agency. Some publish them in legislation, others in guidance documents or notification portals.
Re-check before every launch and at regular intervals. National values can be revised. A figure taken from a past project or a third-party table should be confirmed at source. When the forms and target markets are settled, the quote form is the place to request materials with their specifications.