Foodstuffs for particular nutritional uses

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.

ACT

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

SUMMARY

This Directive applies to foodstuffs 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:

• those whose digestive processes or metabolism are disturbed;
• those suffering from a particular physiological condition; and
• infants or young children in good health.

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

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

• infant formulae and follow-on formulae;
• processed cereal-based foods and baby foods for infants and young children;
• foods intended for weight reduction;
• dietary foods for special medical purposes;
• foodstuffs for persons who are gluten-intolerant.

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.

Specific nutritional substances

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.

Labelling, presentation and advertising

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:

• the composition or manufacturing process which gives the product its particular nutritional characteristics;
• the energy value in kilojoules (kj) and kilocalories (kcal);
• the carbohydrate, protein and fat content per 100 grams or 100 millilitres of product.

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.

Placing on the market

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.

Suspension and withdrawal from sale

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.

The Commission shall examine the reasons given by the Member State and consult the Standing Committee on the Food Chain and Animal Health before taking the appropriate measures.

RELATED ACTS

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.

Last updated: 25.06.2014