Regulation

Food Supplements Directive (2002/46/EC)

Directive 2002/46/EC defines food supplements as a category of food and harmonises the permitted vitamins and minerals across the EU. The Directive is implemented through national law, and many compositional questions — permitted plants, maximum doses — remain national.

The instrument

Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements is the principal EU instrument on food supplements. Unlike Regulation (EC) No 1223/2009 on cosmetics, it is a directive, which means Member States must transpose its content into national law. Some matters are harmonised at EU level — the definition, the list of permitted vitamins and minerals — while others, including national maximum levels and the regime applicable to ingredients other than vitamins and minerals, remain national competences within the framework of EU food law.

Is the Directive still in force?

Yes. Directive 2002/46/EC has not been repealed or replaced by a regulation. It has been amended several times — chiefly to update the lists of permitted vitamin and mineral substances in Annex II and to align the comitology procedure with the Treaty of Lisbon — and the consolidated text on EUR-Lex reflects those amendments. When reading it, always use the latest consolidated version rather than the 2002 original. Food supplements are also subject to horizontal EU food law that post-dates the Directive, notably Regulation (EC) No 178/2002 (general food law), Regulation (EU) No 1169/2011 (food information), Regulation (EC) No 1924/2006 (claims), Regulation (EC) No 1925/2006 (addition of vitamins, minerals and certain other substances) and Regulation (EU) 2015/2283 (novel foods).

Definition of a food supplement

Article 2(a) 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, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities."

Three elements are decisive: a food supplement is (i) a foodstuff, not a medicinal product; (ii) it is intended to supplement a normal diet, not to replace it; and (iii) it is marketed in dose form. A product presented for the prevention or treatment of disease is not a food supplement but a medicinal product, and falls outside Directive 2002/46/EC.

Permitted vitamins and minerals

Annex I to the Directive sets out the vitamins and minerals that may be used in the manufacture of food supplements (for example, vitamins A, D, E, K, C, the B-group vitamins; calcium, magnesium, iron, zinc, selenium, iodine and others). Annex II lists the chemical forms in which these vitamins and minerals may be used (for example, ascorbic acid, sodium ascorbate, calcium ascorbate as forms of vitamin C). Both Annexes have been amended over time as new forms have been assessed and authorised.

The Directive does not set EU-wide maximum and minimum levels of vitamins and minerals in food supplements. Article 5 contemplates that maximum levels are to be set "taking into account upper safe levels … established by scientific risk assessment …" and the intake from other dietary sources, but the implementing EU measures envisaged in Article 5(4) have not been adopted at the time of writing. As a result, maximum levels are set nationally and vary across Member States.

Maximum and minimum levels

Article 5 of the Directive sets out the criteria on which maximum amounts of vitamins and minerals are to be based — upper safe levels established by scientific risk assessment, intakes from other dietary sources, and reference intakes for the population — and provides that minimum amounts should ensure a significant quantity is present. Because the EU-wide figures foreseen in Article 5(4) have not been adopted, there is no harmonised EU maximum for, say, vitamin D or magnesium in a daily dose. Member States apply their own limits, set out in national legislation or in guidance; some publish binding maxima while others assess products case by case. A product formulated for one national market may therefore need to be reformulated before it is sold in another.

Botanicals and other substances

The Directive's harmonised positive lists cover only vitamins and minerals. "Other substances with a nutritional or physiological effect" — amino acids, fatty acids, fibres, plant extracts and similar — fall outside those lists and are governed by national rules, subject to several EU-level instruments:

• Regulation (EC) No 1925/2006, Article 8, allows the EU to prohibit, restrict or place under scrutiny substances other than vitamins and minerals when a potential harmful effect is identified. Its Annex III lists such substances; entries have included, for example, hydroxyanthracene derivatives from certain laxative plants and monacolins from red yeast rice.
• Regulation (EU) 2015/2283 on novel foods applies to ingredients not consumed to a significant degree in the EU before 15 May 1997; these need authorisation before use.
• National plant lists — for example the French arrêté of 24 June 2014 on plants other than fungi, the Italian Ministry of Health list of permitted botanicals, and the Belgian royal decree on plants — determine which botanicals may be used nationally. The "BELFRIT" list developed jointly by Belgium, France and Italy is a shared reference for those three countries.

There is no harmonised EU maximum dose for botanical ingredients; limits, where they exist, are national.

Labelling requirements

Article 6 of Directive 2002/46/EC requires that products sold as food supplements bear the name "food supplement" and the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties. Article 8 requires that the amount of nutrients or substances with a nutritional or physiological effect be declared on the label in numerical form, by reference to the unit serving recommended for daily consumption.

Article 6(3) adds mandatory label particulars specific to food supplements: the names of the categories of nutrients or substances that characterise the product; the portion recommended for daily consumption; a warning not to exceed the stated recommended daily dose; a statement that food supplements should not be used as a substitute for a varied diet; and a statement that the products should be stored out of the reach of young children. Under Article 9, vitamin and mineral amounts may also be expressed as a percentage of the reference values (now set out in Annex XIII to Regulation (EU) No 1169/2011). In practice, mineral amounts are declared as the mineral itself (for example, milligrams of magnesium) rather than as the weight of the compound used (such as magnesium oxide). The European Commission has published guidance on tolerances for nutrient values declared on labels.

The Directive interlocks with the general EU food information rules under Regulation (EU) No 1169/2011 on the provision of food information to consumers, which require allergen labelling, nutrition declaration in the appropriate form, and accurate identification of the food business operator.

National implementation

Because Directive 2002/46/EC is a directive, each Member State has its own transposing instrument and may add national rules within the latitude the Directive leaves. Examples:

• France — Décret n° 2006-352 of 20 March 2006 on food supplements, supplemented by orders (arrêtés) on permitted substances and plants. Notification to the DGCCRF is required.
• Italy — Decreto legislativo 21 maggio 2004, n. 169, supplemented by Ministero della Salute decrees. Notification regime managed by the Ministero.
• Spain — Real Decreto 1487/2009, of 26 October, on food supplements (complementos alimenticios).
• Portugal — Decreto-Lei n.º 136/2003 of 28 June, as amended (notably by Decreto-Lei n.º 118/2015 of 23 June, which revised the notification procedure).
• Belgium — Royal Decree of 3 March 1992 on nutrients and foods with added nutrients, together with a separate royal decree on foods containing plants or plant preparations (originally of 29 August 1997, since revised; check the FPS Public Health for the current text). Notification is made to the FPS Public Health.

Many Member States, including France, Italy and Belgium, maintain national lists of plants permitted in food supplements. These lists are not harmonised at EU level, with the consequence that a plant-based supplement that is legally on the market in one Member State may require additional assessment to be placed on the market in another. The principle of mutual recognition applies, but Member States may invoke public-health grounds to restrict placing on the market.

Relationship with health claims

Any nutrition or health claim made on a food supplement is subject to Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. Only claims authorised under that regulation, and listed in the EU Register of nutrition and health claims, may be used. Claims for botanical substances (sometimes called "botanicals") are in a particular position: a large number of botanical claims are currently "on hold" in the EU Register, pending further EFSA assessment, and may continue to be used under transitional arrangements pending a decision.

Border with medicinal products

The decisive question for the classification of a product as food supplement or as medicinal product is its presentation and function. A product that claims to treat, prevent or cure a disease is a medicinal product by presentation (Article 1(2)(a) of Directive 2001/83/EC); a product whose composition gives it a pharmacological, immunological or metabolic action sufficient to fall within Article 1(2)(b) is a medicinal product by function. Member State authorities make these classifications product by product; the Court of Justice of the European Union has held that close cases (so-called "borderline products") are to be decided on a case-by-case basis taking into account all characteristics of the product.

Frequently asked questions

Is Directive 2002/46/EC still in force?

Yes. The Directive has been amended several times but has not been repealed or replaced. Always consult the latest consolidated text on EUR-Lex.

How does Directive 2002/46/EC define a food supplement?

Article 2(a) defines food supplements as foodstuffs intended to supplement the normal diet that are concentrated sources of nutrients or other substances with a nutritional or physiological effect, marketed in dose form such as capsules, tablets, sachets of powder or measured liquids.

Does the Directive set EU maximum levels for vitamins and minerals?

No. Article 5 sets the criteria for maximum levels, but the EU-wide limits it envisages have not been adopted, so maximum levels are set nationally and differ between Member States.

Are herbal and botanical supplements covered by Directive 2002/46/EC?

They fall within the definition of a food supplement, but the Directive's harmonised lists cover only vitamins and minerals. Botanicals are governed mainly by national rules, subject to EU instruments such as Regulation (EC) No 1925/2006 and the novel food regulation.

Can a food supplement claim to prevent or treat a disease?

No. Article 6(2) prohibits attributing to food supplements the property of preventing, treating or curing a human disease. Nutrition and health claims must be authorised under Regulation (EC) No 1924/2006.

What must appear on a food supplement label?

The name 'food supplement'; the categories of nutrients or substances; the recommended daily portion; a warning not to exceed it; a statement that supplements are not a substitute for a varied diet; a statement to store out of reach of young children; and the amount of each nutrient per daily portion, in addition to general food labelling rules.

Last reviewed: October 2026.