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.

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.

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.

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 September.
• Portugal — Decreto-Lei n.º 118/2015 of 23 June, on food supplements.
• Belgium — Royal Decrees of 3 March 1992 and 29 August 1997 (the latter on plants in food).

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.

Last reviewed: May 2026.