Directive 2009/39/EC of the European Parliament and of the Council (repealed)Show full title

Article 1

1. This Directive concerns foodstuffs for particular nutritional uses.

2. Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.

3. A particular nutritional use shall fulfil the particular nutritional requirements:

(a) of certain categories of persons whose digestive processes or metabolism are disturbed; or

(b) of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or

(c) of infants or young children in good health.

Article 2

1. The products covered by points (a) and (b) of Article 1(3) may be characterised as ‘dietetic’ or ‘dietary’.

2. In the labelling, presentation and advertising of foodstuffs for normal consumption the following shall be prohibited:

(a) the use of the adjectives ‘dietetic’ or ‘dietary’ either alone or in conjunction with other words, to designate those foodstuffs;

(b) all other markings or any presentation likely to give the impression that one of the products referred to in Article 1 is involved.

However, in accordance with provisions to be adopted by the Commission, it shall be possible for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability.

Such provisions may lay down the arrangements for indicating that suitability.

The measures referred to in the second subparagraph, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

Article 3

1. The nature or composition of the products referred to in Article 1 shall be such that the products are appropriate for the particular nutritional use intended.

2. The products referred to in Article 1 shall also comply with any mandatory provisions applicable to foodstuffs for normal consumption, save as regards changes made to them to ensure their conformity with the definitions given in Article 1.

Article 4

1. The specific provisions applicable to the groups of foodstuffs for particular nutritional uses appearing in Annex I shall be laid down by means of specific Directives.

Such specific Directives may cover in particular:

(a) essential requirements as to the nature or composition of the products;

(b) provisions regarding the quality of raw materials;

(c) hygiene requirements;

(d) permitted changes within the meaning of Article 3(2);

(e) a list of additives;

(f) provisions regarding labelling, presentation and advertising;

(g) sampling procedures and methods of analysis necessary for checking compliance with the requirements of the specific Directives.

Such specific Directives shall be adopted:

• in the case of point (e), in accordance with the procedure laid down in Article 95 of the Treaty,

• in the case of the other points, by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

Provisions likely to have an effect on public health shall be adopted after consultation of the European Food Safety Authority.

2. To enable foodstuffs intended for particular nutritional uses and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the European Food Safety Authority, authorise for a two-year period the placing on the market of foodstuffs which do not comply with the rules as to composition laid down by the specific Directives for groups of foodstuffs for particular nutritional uses referred to in Annex I. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

If necessary, the Commission may add in the authorisation decision labelling rules relating to the change in composition.

3. The Commission shall adopt a list of substances with specific nutritional purposes such as vitamins, mineral salts, amino acids and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them, and, where appropriate, the conditions under which they should be used.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(4).

Article 5

The Commission shall adopt rules for the use of terms concerning the reduction or absence of sodium or salt (sodium chloride, table salt) content or the absence of gluten, which may be used to describe the products referred to in Article 1.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

Article 6

Before 8 July 2002, the Commission shall, after consulting the European Food Safety Authority, present to the European Parliament and to the Council a report on the desirability of special provisions for foods for persons suffering from carbohydrate metabolism disorders (diabetes).

In the light of the conclusions of that report, the Commission shall either:

(a)

proceed with the preparation of the special provisions concerned; or

(b)

present, in accordance with the procedure laid down in Article 95 of the Treaty, any appropriate proposals for amendments to this Directive.

The measures referred to in point (a), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

Article 7

The Commission may adopt conditions under which reference may be made in labelling, presentation and advertising to a diet or to a category of persons for which a product referred to in Article 1 is intended.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

Article 8

1. The labelling and the labelling methods used, the presentation and the advertising of the products referred to in Article 1 shall not attribute properties to such products for the prevention, treatment or cure of human disease or imply such properties.

Derogations from the first subparagraph may be provided for in exceptional and clearly defined cases. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). Derogations may be continued until that procedure has been completed.

2. Paragraph 1 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition or pharmacy.

Article 9

1. Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1) shall apply to the products referred to in Article 1 of this Directive, under the conditions set out in paragraphs 2, 3 and 4 of this Article.

2. The designation under which a product is sold shall be accompanied by an indication of its particular nutritional characteristics. However, in the case of the products covered by point (c) of Article 1(3), that reference shall be replaced by a reference to the purpose for which they are intended.

3. The labelling of products for which no specific Directive has been adopted in accordance with Article 4 shall also include:

(a) the particular elements of the qualitative and quantitative composition or the special manufacturing process which gives the product its particular nutritional characteristics;

(b) the available energy value expressed in kilojoules and kilocalories and the carbohydrate, protein and fat content per 100 grams or 100 millilitres of the product as marketed and, where appropriate, per specified quantity of the product as proposed for consumption.

If, however, the energy value is less than 50 kilojoules (12 kilocalories) per 100 grams or 100 millilitres of the product as marketed, those particulars may be replaced either by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 grams’ or by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 millilitres’.

4. The particular labelling requirements for those products for which a specific Directive has been adopted shall be laid down in that Directive.

Article 10

1. The products referred to in Article 1 shall only be allowed on the retail market in pre-packaged form, and the packaging shall completely cover the products.

2. Member States may permit derogations from paragraph 1 for purposes of the retail trade provided that the product is accompanied by the particulars provided for in Article 9 at the time when it is put on sale.

Article 11

1. To permit efficient official monitoring of foodstuffs intended for a particular nutritional use which do not belong to one of the groups listed in Annex I, the following specific provisions shall apply:

(a) when a product as referred to above is placed on the market for the first time the manufacturer or, where a product is manufactured in a third State, the importer, shall notify the competent authority of the Member State where the product is being marketed by forwarding it a model of the label used for the product;

(b) where the same product is subsequently placed on the market in another Member State the manufacturer or, where appropriate, the importer, shall provide the competent authority of that Member State with the same information, together with an indication of the recipient of the first notification;

(c) where necessary, the competent authority shall be empowered to require the manufacturer or, where appropriate, the importer, to produce the scientific work and the data establishing the product's compliance with Article 1(2) and (3) together with the information provided for in point (a) of Article 9(3). If such work is contained in a readily available publication, a mere reference to this publication shall suffice.

2. Member States shall communicate to the Commission the identity of the competent authorities within the meaning of paragraph 1 and any other useful information on them.

The Commission shall publish this information in the Official Journal of the European Union.

3. Detailed rules for implementing paragraph 2 may be adopted in accordance with the regulatory procedure referred to in Article 15(2).

4. Every three years, and for the first time before 8 July 2002, the Commission shall send the European Parliament and the Council a report on the implementation of this Article.

Article 12

1. Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and, where appropriate, with Directives adopted in implementation of this Directive.

2. Paragraph 1 shall not affect national provisions which are applicable in the absence of Directives adopted in implementation of this Directive.

Article 13

1. Where a Member State has detailed grounds for establishing that a foodstuff intended for a particular nutritional use which does not belong to one of the groups listed in Annex I does not comply with Article 1(2) and (3) or endangers human health, albeit freely circulating in one or more Member States, that Member State may temporarily suspend or restrict trade in that product within its territory. It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision.

2. The Commission shall examine, as soon as possible, the grounds adduced by the Member State concerned, shall consult the Member States within the Committee referred to in Article 15(1), and shall then deliver its opinion without delay and take appropriate measures.

3. If the Commission considers that the national measure must be dispensed with or modified, it shall adopt the appropriate measures in accordance with the regulatory procedure referred to in Article 15(2).

Article 14

1. Where a Member State, as a result of new information or of a reassessment of existing information made since one of the specific Directives was adopted, has detailed grounds for establishing that a foodstuff intended for a particular nutritional use endangers human health although it complies with the relevant specific Directive, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.

2. The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Committee referred to in Article 15(1), and shall then deliver its opinion without delay and take appropriate measures.

3. If the Commission considers that amendments to this Directive or to the specific Directives are necessary in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall adopt those amendments.

Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(4).

The Member State which has adopted safeguard measures may in that event retain them until the amendments have been adopted.

Article 15

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council(2).

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Article 16

Directive 89/398/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex II, Part B.

References made to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 17

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 18

This Directive is addressed to the Member States.

Done at Strasbourg, 6 May 2009.

For the European Parliament

The President

H.-G. Pöttering

For the Council

The President

J. Kohout