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Food supplements

Food supplements (vitamins and mineral salts) are harmonised within the European Union (EU). They are analysed beforehand and approved by the European Food Safety Authority (EFSA). The Commission is also responsible for establishing purity criteria for these substances.

ACT

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 [See amending acts].

SUMMARY

Scope

This Directive concerns food supplements, defined as concentrated sources of nutrients (vitamins and mineral salts) or other substances with a nutritional or physiological effect, alone or in combination, which are marketed in dose form (e.g. capsules, tablets, sachets, etc.) in order to supplement a normal diet.
Proprietary medicinal products as defined by Directive 2001/83/EC establishing a Community Code relating to medicinal products for human use.

Composition of food supplements

With regard to vitamins and minerals, food supplements may only contain the vitamins and mineral salts laid down in Annex I of the Directive, and the vitamin and mineral formulations listed in Annex II, singly or in combination.

The Commission is responsible for establishing the purity criteria for substances contained in food supplements, and the maximum and minimum quantities authorised, with the assistance of the Standing Committee on the Food Chain and Animal Health.

Labelling

The products covered by the Directive are sold under the name “food supplements”. Furthermore, without prejudice to the provisions of Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs, the labelling of food supplements must contain:

  • the names of the categories of the nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances;
  • the portion of the product recommended for daily consumption and a warning of the risks to health if this is exceeded;
  • a declaration to the effect that the supplement is not a substitute for a varied diet;
  • the reference "This is not a medicinal product", where the presentation of the product is similar to that of a medicinal product;
  • a warning to the effect that the product should be stored out of the reach of young children.

The labelling of food supplements must not contain:

  • any statement attributing to the product properties of preventing, treating or curing a human disease;
  • any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.

Monitoring system

To facilitate efficient monitoring of food supplements, the Directive provides that Member States may require the manufacturer or the person placing the product on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used.

Safeguard clause

The Member States may not prohibit or restrict trade in food supplements which comply with this Directive, except where they find that the products pose a public health risk. Where such a risk occurs, a Member State may temporarily suspend or restrict application of the provisions of the Directive. It shall immediately inform the other Member States and the European Commission thereof and give reasons for its decision. The Commission shall examine the grounds adduced by the Member State for temporarily suspending or restricting the trade in food supplements and shall consult the Standing Committee on the Food Chain and Animal Health before delivering its opinion and taking appropriate measures.

Committees

The Commission will be assisted in implementing the Directive by the Standing Committee on the Food Chain and Animal Health (e.g. determining the purity criteria for nutrients, establishing maximum levels, amending annexes, etc.).
In addition, the Commission shall consult the European Food Safety Authority (EFSA) before adopting provisions which may influence public health.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal

Directive 2002/46/EC

12.7.2002

Marketing authorisation for products which comply: 1.8.2003

Marketing ban for products which do not comply: 1.8.2005

OJ L 183 of 12.7.2002

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal

Regulation (EC) No 1137/2008

11.12.2008

-

OJ L 311 of 21.11.2008

Successive amendments and corrections to Directive 2002/46/EC have been incorporated into the basic text. This consolidated version is for information only.

AMENDMENT OF ANNEXES

Annex I - Vitamins and minerals which may be used in the manufacture of food supplements
Regulation (EC) No 1170/2009 [Official Journal L 314 of 1.12.2009].

Annex II – Vitamin and mineral substances which may be used in the manufacture of food supplements
Directive 2006/37/EC [Official Journal L 94 of 1.4.2006];
Regulation (EC) No 1170/2009 [Official Journal L 314 of 1.12.2009].

RELATED ACTS

Report from the Commission to the Council and the European Parliament of 5 December 2008 on the use of substances other than vitamins and minerals in food supplements [COM(2008) 824 – Not published in the Official Journal].
The Commission concludes that the existing Community legal instruments are satisfactory. Consequently, it is not necessary to lay down specific rules for substances other than vitamins or minerals for use in food supplements. The market for food supplements is extremely varied from one Member State to another. The use of these substances is therefore subject to the rules in force in national legislation without prejudice to any other Community provisions which are applied to them. However, the Commission does not rule out the possibility of carrying out a supplementary analysis, examining the conditions for the addition of these substances to foodstuffs in general, since they are now being added to ordinary foodstuffs.

Last updated: 24.08.2010
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