Answer to Written Question: Medicines and food supplements

(Source: European Parliament)



Answer given by Ms Kyriakides

on behalf of the European Commission


While Directive 2002/46/EC[1] provides a definition of food supplements, Article 1(2) of Directive 2001/83/EC[2] defines medicinal products.

The classification of a product as a food supplement or a medicinal product is under the remit of Member States. Moreover, according to Article 2(2) of Directive 2001/83/EC, in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply. This priority rule applies when Member States consider the classification of products.

According to Article 6(2) of Directive 2002/46/EC, 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. However, Regulation (EC) No 1924/2006[3] sets out rules on the use of nutrition and health claims in food, including food supplements.

The development and implementation of information campaigns for citizens falls within the remit of Member States.

[1] 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. Select: 1, OJ L 183, 12.7.2002, p. 51–57.

[2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Select: 1, OJ L 311, 28.11.2001, p. 67–12.

[3] Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.

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