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Foodstuffs intended for particular nutritional uses

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The presentation of foodstuffs intended for particular nutritional uses (infants, people who have digestive or metabolic disorders or a particular physiological condition) is standardised. These products have specific labelling requirements, for example declaration of the energy value and the carbohydrate, protein and fat content.

ACT

Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of Member States relating to foodstuffs intended for particular nutritional uses [See amending acts].

SUMMARY

Directive 89/398/EEC

The Directive applies to foodstuffs intended for particular nutritional uses. They must be suitable for their claimed nutritional purposes, and marketed in such a way as to indicate their suitability. A particular nutritional use must fulfil the particular nutritional requirements of:

  • certain categories of persons whose digestive system or metabolism is disturbed,
  • certain categories of persons who are in a special physiological condition,
  • infants or young children in good health.

The use of the adjectives "dietetic" or "dietary" is prohibited in the labelling, presentation and advertising of foodstuffs for normal consumption.

Specific provisions for groups of foods for particular nutritional uses will be laid down in specific Directives. These may include compositional requirements, hygiene requirements, list of additives, purity criteria, etc. Specific labelling requirements in addition to those required for foodstuffs in general, e.g. declaration of the energy value, carbohydrate, protein and fat content.

The Directive establishes the procedure to be followed if a particular foodstuff, though complying with the relevant specific Directive, is believed to endanger human health.

It also introduces provisions for the adoption of future specific Directives. Annex I to the Directive constitutes a list of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific Directives:

Directive 96/84/EC

To enable foodstuffs intended for particular nutritional uses to be placed on the market rapidly, this Directive allows a two-year marketing authorisation, following evaluation by the European Food Safety Authority, for foodstuffs which otherwise would not comply with the composition rules laid down by the specific Directives.

Directive 1999/41/EC

This Directive amends Annex I to Directive 89/398/EEC, removing from the list three categories of foodstuffs for which the adoption of specific directives was envisaged: foods for diabetics, low-sodium foods, including low-sodium or sodium-free dietary salts, and gluten-free foods. These foods may be regulated by Directive 89/398/EEC without the adoption of specific Directives.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 89/398/EEC16.05.1990: marketing authorisation for products which comply with the Directive
16.05.1991: marketing ban on products which do not comply with the Directive
16.05.1989OJ L 86 of 30.06.1989

Amending act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Directive 96/84/EC11.03.199730.09.1997OJ L 48 of 19.02.1997
Directive 1999/41/EC08.07.2000: marketing authorisation for products which comply with the Directive
08.07.2001: marketing ban on products which do not comply with the Directive
08.07.2000OJ L 172 of 08.07.1999
Regulation (EC) No 1882/200320.11.2003-OJ L 284 of 31.10.2003

RELATED ACTS

Proposal for a Directive of the European Parliament and of the Council on foodstuffs intended for particular nutritional uses [COM(2004) 290 final - Not published in the Official Journal]

This future Directive proposes to simplify the body of the Directive by including its various amendments in a single text.

COMPOSITION OF FOODSTUFFS FOR SPECIFIC NUTRITIONAL USES

Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses [Official Journal L 52 of 22.02.2001]

This Directive identifies the nutritional substances which may be used in foods for particular nutritional uses. It authorises the addition of the following nutritional substances:

  • chemical substances listed in the Annex to the Directive which belong to certain categories of substance (vitamins, minerals, amino acids, carnitines and taurines, nucleotides, cholines and inositols).
    These chemical substances have been selected on the basis of their safety, their availability for use by humans, and their organoleptic and technological properties. The purity criteria generally applied by Community legislation for the manufacture of foods or, failing that, the generally acceptable purity criteria recommended by international agencies apply to them;
  • chemical substances belonging to categories of substance other than vitamins, minerals, amino acids, carnitines and taurines, nucleotides, and cholines and inositols.

Foods to which these nutritional substances are added must be safe and must fulfil the particular nutritional requirements of the persons for whom they are intended. Trade in products complying with this Directive is permitted with effect from 1 April 2002. Conversely, trade in products which do not comply will no longer be permitted after 1 April 2004.

Amended by:

Commission Directive 2004/5/EC [Official Journal L 014 of 21.01.2004].
The Annex to Directive 2001/15/EC includes the following chemical substances: sulphate, L-serine, L-arginine-L-aspartate, L-lysine-L-glutamate, N-acetyl-L-Cysteine, N-acetyl-L-methionine and L-carnitine-L-tartrate.
These substances, added to foodstuffs intended for particular nutritional uses, have been approved by the Scientific Committee for Food or by the European Food Safety Authority (EFSA). (The powers of the five scientific committees on food safety were given to a single body, the EFSA, as of 2003).

Commission Directive 2006/34/EC [Official Journal L 83 of 22.03.2006].
In the category for vitamins, the heading "folic acid" is replaced by "folate".

 
Last updated: 09.08.2007

See also

For further information concerning foodstuffs intended for particular nutritional uses, please visit the website of the Directorate-General for Health and Consumer Protection.

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