Permitted forms of vitamins and minerals under Directive 2002/46/EC

Picking vitamin C for a supplement sounds simple — until you realise the EU does not let you use just any form of it. Ascorbic acid, sodium ascorbate, calcium ascorbate: some are permitted, some are not, and choosing a form that is not on the list makes the product non-compliant no matter how good the nutrient is. Under Directive 2002/46/EC, the form is as regulated as the nutrient itself.

The directive behind EU supplements

Food supplements in the EU are governed primarily by Directive 2002/46/EC. Among other things, it sets out which vitamins and minerals may be used in supplements — and, crucially, which specific chemical forms (the substances) are permitted as sources of each one.

That second part is where many formulations quietly go wrong. It is not enough that "vitamin C" or "magnesium" is allowed. The exact source you use — the salt, the ester, the complex — has to appear on the permitted list.

Two positive lists, not one

The directive works on a positive-list basis. There is a list of the vitamins and minerals that may be added, expressed as the nutrient, and a list of the permitted substances — the chemical forms through which those nutrients may be delivered.

So a compliant choice has to satisfy both: the nutrient must be permitted, and the form you have chosen to supply it must be a permitted source of that nutrient. A form that is not listed cannot be used, even for a nutrient that is otherwise allowed.

Why the form matters so much

Different forms of the same nutrient behave differently — in bioavailability, in stability, and in how much elemental nutrient they actually deliver. A mineral salt carries only a fraction of its weight as the active mineral, and that fraction differs between forms. Magnesium oxide and magnesium citrate are not interchangeable on a milligram-for-milligram basis.

This means the form is not just a compliance checkbox. It feeds directly into how much elemental nutrient your formula provides — which in turn drives your nutrition declaration, your reference-value percentages, and your claim eligibility. Get the form wrong and several downstream calculations are wrong with it.

The elemental-content trap

Here is the mistake that catches teams out. A formula calls for a certain amount of a mineral. Someone enters the weight of the mineral salt rather than the elemental mineral it actually contributes. The label then overstates what the product delivers, and the claim that depended on that amount may not actually be supported.

Every mineral source needs to be characterised by its elemental contribution, not just its raw weight. The permitted form and its elemental factor have to travel together, or the arithmetic drifts.

Forms change; lists change

The permitted-substances lists are not frozen. New forms can be evaluated and added, and the regulatory picture for any given source can evolve. A form that is fine today may carry conditions, and a new form a supplier offers may not yet be permitted at all.

For a manufacturer, that means checking a form once at the start of a product's life is not the same as knowing the status of every form across a live catalogue. Supplier specifications change, sourcing changes, and the lists are maintained over time.

Where this connects to the rest of compliance

Permitted forms do not sit in isolation. They link to upper intake limits (the elemental amount is what is measured against the limit), to claims (eligibility depends on the elemental amount delivered), and to allergen and suitability questions (some forms carry carriers or are animal-derived). The choice of form ripples across the whole compliance picture of the product.

Building the check into formulation

The reliable approach is to attach the permitted-form status and the elemental factor to every ingredient, so that the moment a source is added to a formula the system knows whether it is a permitted form and how much elemental nutrient it contributes. A non-listed form is flagged before it becomes a problem, and the elemental amount flows automatically into the declaration and the claim checks.

Instead of cross-referencing a separate list by hand for every nutrient in every product, the question "is this form allowed, and what does it actually deliver?" is answered as you formulate.

The takeaway

Directive 2002/46/EC regulates not just which vitamins and minerals you may use, but the exact forms you may use to supply them — and the form determines the elemental nutrient your product actually delivers. Treat the permitted form and its elemental contribution as properties of the ingredient, checked as you build the formula, and both compliance and the numbers downstream stay right.

Lemoniq carries the permitted-form status and elemental contribution of every ingredient, so a non-listed form is flagged and the right elemental amount flows into your declarations and claims as you formulate — we solve this exact problem. See how it works