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Dietary foods for special medical purposes
Dietary foods for special medical purposes
Dietary foods for special medical purposes
This summary has been archived and will not be updated. See
'Hrana za posebne medicinske potrebe'
for an updated information about the subject.
Dietary foods for special medical purposes
This Directive lays down compositional and labelling requirements for dietary foods for special medical purposes.
ACT
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes [See amending act(s)].
SUMMARY
This Directive is a specific directive as described in Article 4 of Directive 2009/39/EC. It lays down compositional and labelling requirements for dietary foods which are intended for special medical purposes * and are presented as such.
Classification
Dietary foods for special medical purposes are classified in three categories:
General obligation
Member States shall ensure that dietary foods for special medical purposes may be marketed within the European Union (EU) only if they comply with the rules laid down in this Directive.
Composition
The formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles. Their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. They must comply with the compositional criteria specified in the Annex.
Trade name
This Directive specifies the name under which dietary foods for special medical purposes are sold in the 22 official languages of the EU.
Compulsory indications
In addition to the particulars provided for in Article 3 of Directive 79/112/EC, the labelling of dietary foods for special medical purposes shall bear the following mandatory particulars:
The labelling must also include the following mandatory particulars, preceded by the words "important notice" or their equivalent:
The labelling shall also include:
The labelling shall bear instructions for the appropriate preparation, use and storage of the product after the opening of the container, as appropriate.
Foods for infants
This Directive also sets maximum and minimum values for vitamins, minerals and trace elements in nutritionally complete foods intended for use by infants *.
Directive 2006/141/EC adapts one of its values, the minimum level of manganese in foods intended for infants, to take account of the latest scientific advice. The new requirements for infant formulae manufactured from cows' milk proteins or based on protein hydrolysates shall apply mandatorily to infant dietary foods for special medical purposes as of 1 January 2012.
Official monitoring
To facilitate efficient official monitoring of dietary foods for special medical purposes, when a product is placed on the market, the manufacturer or, where a product is manufactured in a third country, the importer shall notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. Member States may, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation.
Key terms used in the act
References
Act |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Directive 1999/21/EC |
27.4.1999 |
30.4.2000 |
OJ L 91, 7.4.1999 |
Amending act(s) |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Acts of Accession to the EU of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia. Annex II: List referred to in Article 20 of the Act of Accession - 1.Free movement of goods - J. Foodstuffs. |
1.5.2004 |
No later than 2007 |
OJ L 236, 23.9.2003 |
Directive 2006/82/EC |
1.1.2007 |
1.1.2007 |
OJ L 362, 20.12.2006 |
The successive amendments and corrections to Directive 1999/21/EC have been incorporated into the basic text. This consolidated version is for information only.
Last updated: 07.07.2011