EU Food Supplements Directive 2002/46/EC — What North American Brands Must Know

A supplement brand that has operated successfully in the United States under the Dietary Supplement Health and Education Act (DSHEA) of 1994 will find the EU regulatory environment structured around fundamentally different assumptions. In the US, a dietary supplement is presumed safe unless the FDA demonstrates otherwise. In the EU, the starting point is closer to the reverse: only substances that have been positively listed or assessed may be used in food supplements sold across the single market. That distinction has practical consequences that affect formulation, labeling, and market strategy before a single product ships.

This article is for supplement brand owners, regulatory affairs managers, and executives at North American companies evaluating EU market entry. It explains the framework established by Directive 2002/46/EC, where it leaves gaps that member states fill independently, and what your compliance checklist should include.

The Directive and Its Scope

Directive 2002/46/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to food supplements was adopted on 10 June 2002 and has been in force since 2003. It defines food supplements as foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form.

The Directive applies to food supplements sold as such to the final consumer. It does not apply to medicinal products as defined by Directive 2001/83/EC, nor to food for particular nutritional uses (now largely governed by Regulation (EU) No 609/2013). The boundary between a food supplement and a medicinal product is one of the most consequential classification questions in EU supplement regulation, and it is assessed on a case-by-case basis by national competent authorities. Requirements vary by member state, and a product classified as a food supplement in one country may be classified as a medicinal product in another.

Permitted Vitamins and Minerals

Annex I of the Directive lists the vitamins and minerals that may be used in food supplements. Annex II lists the permitted vitamin and mineral forms (sources). Only the vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used in food supplements marketed under the Directive.

This is a significant constraint for North American brands. Certain mineral forms commonly used in US supplements — particular chelates, for example — may not appear in Annex II. If a form is not listed, it may not be used in an EU food supplement, regardless of its safety profile or its acceptance by the FDA or Health Canada.

The European Commission has the authority to add new substances to the Annexes following a safety assessment by the European Food Safety Authority (EFSA). Brands wishing to use a non-listed substance must petition for its addition, a process that requires a dossier submission to EFSA and can take several years.

Maximum and Minimum Levels

The Directive mandates that maximum and minimum levels of vitamins and minerals in food supplements be set by the Commission, taking into account safe upper levels established through scientific risk assessment, reference intakes, and intake from other dietary sources. However, as of the time of writing, the Commission has not yet adopted harmonised maximum levels across the EU. This means that maximum levels are currently set at the national level by individual member states.

This creates a patchwork compliance challenge. A vitamin D supplement formulated at a dose that is legal in the Netherlands may exceed the maximum permitted level in France or Germany. Brands planning multi-country EU launches must map permitted levels country by country and, in some cases, maintain different formulations or dosage forms for different markets.

Labeling Requirements Under the Directive

Article 6 of the Directive specifies labeling requirements for food supplements. Labels must include:

The names of the categories of nutrients or substances that characterise the product, or an indication of the nature of those nutrients or substances
The portion of the product recommended for daily consumption
A warning not to exceed the recommended daily dose
A statement that food supplements should not be used as a substitute for a varied diet
A statement that the products should be kept out of the reach of young children

Labels must not attribute to food supplements the property of preventing, treating, or curing a human disease, or refer to such properties. This prohibition aligns with the broader EU framework on nutrition and health claims governed by Regulation (EC) No 1924/2006, which requires that any health claim made on a food supplement be authorised and appear on the EU Register of authorised claims.

This is a material difference from the US DSHEA framework, which permits structure/function claims without pre-market authorisation, provided a disclaimer is included. EU health claims require positive authorisation, and the list of authorised claims is more limited than many North American brands expect.

Notification Requirements

Most EU member states require notification to the national competent authority before a food supplement is placed on the market. The notification process, required documentation, and timelines vary by country. Some member states require only a simple notification with a label copy; others require more detailed compositional information. Brands should map notification requirements for each target market before launch.

Practical Action Step

Use this checklist when preparing a food supplement for EU market entry:

Confirm the product is classified as a food supplement (not a medicinal product) in each target member state
Verify all vitamins and minerals against Annexes I and II of Directive 2002/46/EC
Check permitted maximum levels for each vitamin and mineral in each target member state
Review all health claims against the EU Register of authorised nutrition and health claims under Regulation (EC) No 1924/2006
Remove any structure/function claims that are not authorised under EU law
Prepare compliant labels in the official language(s) of each target market
Identify and complete the notification process for each target member state
Confirm that the product is not subject to Novel Food requirements under Regulation (EU) 2015/2283 (see our separate article on Novel Food)

The EU food supplement regulatory landscape is fragmented at the member state level in ways that can surprise brands accustomed to a single national framework. Consult a qualified EU regulatory expert before finalising your formulation, labeling, and market entry strategy.

Care Europe supports supplement brands through EU market entry, including ingredient compliance screening, health claim review, labeling adaptation, and country-by-country notification management. Contact us to discuss your product portfolio.

EU Food Supplements Directive 2002/46/EC — What North American Brands Must Know