The rules relating to foodstuffs intended for particular nutritional uses (for infants and young children, persons whose digestive processes or metabolism are disturbed or for persons with a specific physiological condition) have been harmonised at European level. The labelling of these products should include information concerning the particular characteristics of the product, the energy value or carbohydrate, protein and fat content, etc.

Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses.

These foodstuffs are clearly distinguishable from foodstuffs for normal consumption owing to their composition or manufacturing process. Moreover, they must meet the particular nutritional requirements of the following categories of person:

Only foodstuffs which meet the nutritional requirements of the two first categories of person mentioned above may bear the words dietetic or dietary.

Specific provisions apply to the following groups of foodstuffs for particular nutritional uses:

Detailed provisions shall be laid down in specific directives or regulations which may include provisions mainly relating to the nature or composition of products and to labelling.

It is possible to enrich foodstuffs by adding nutritional substances in order to meet particular nutritional needs and/or particular legal requirements. These enriched foods must be safe for consumption and be prepared on the basis of scientific data.

Their composition must comply with the purity criteria laid down by European legislation and national law, or those recommended by international bodies.

Foodstuffs intended for particular nutritional uses which have not been regulated by a specific directive shall comply with the rules on labelling, presentation and advertising of foodstuffs for general consumption. Nonetheless, the designation under which a dietetic product is sold must be accompanied by an indication of its particular nutritional characteristics and include additional information concerning:

Foodstuffs intended for particular nutritional uses shall only be allowed on the market in pre-packaged form, and the packaging shall completely cover the products, except for the retail trade or if a specific directive provides otherwise.

When a foodstuff that does not belong to the groups of foodstuffs for which specific provisions apply is placed on the market, the manufacturer or importer of the said product shall notify the competent authority of the Member State where the product is marketed for the first time and forward a label of the label used. Where the product is subsequently placed on the market in another Member State, the manufacturer or importer shall send the competent authority of that Member State the model of the label together with an indication of the recipient of the first notification.

The competent authority may require the manufacturer or importer to produce the scientific work and data establishing the foodstuff’s compliance with a particular nutritional objective for one of the three categories of consumer identified above.

A Member State may suspend or restrict trade in a foodstuff intended for particular nutritional uses if the latter endangers human health or if it does not comply with this Directive or the specific directives adopted in implementation of this Directive.

REFERENCES

Act	Entry into force	Deadline for transposition in the Member States	Official Journal
Directive 2009/39/EC	9.6.2009	-	OJ L 124 of 20.5.2009

Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses [Official Journal L 269 of 14.10.2009].

Proposal for a Regulation of the European Parliament and of the Council on food intended for infants and young children and on food for special medical purposes [ COM(2011) 353 final - Not published in the Official Journal]

The Regulation Proposal reviews the framework legislation established by the Directive 2009/39/EC. It abolishes the concept of foodstuffs intended for particular nutritional uses and defines a new framework for certain foodstuff categories, namely food intended for infants and young children and food intended for patients who are under medical supervision.