Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses
Modified by
  • Directive 96/84/EC of the European Parliament and of the Councilof 19 December 1996amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, 31996L0084, February 19, 1997
  • Directive 1999/41/EC of the European Parliament and of the Councilof 7 June 1999amending Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, 31999L0041, July 8, 1999
  • Regulation (EC) No 1882/2003 of the European Parliament and of the Councilof 29 September 2003adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty, 32003R1882, October 31, 2003
  • Directive 2009/39/EC of the European Parliament and of the Councilof 6 May 2009on foodstuffs intended for particular nutritional uses(recast)(Text with EEA relevance), 32009L0039, May 20, 2009
Council Directiveof 3 May 1989on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses(89/398/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,Having regard to the proposal from the CommissionOJ No C 124, 23. 5. 1986, p. 7, and OJ No C 161, 19. 6. 1987, p. 12.,In cooperation with the European ParliamentOJ No C 99, 13. 4. 1987, p. 54, and OJ No C 120, 16. 5. 1989.,Having regard to the opinion of the Economic and Social CommitteeOJ No C 328, 22. 12. 1986, p. 9.,Whereas Council Directive 77/94/EEC of 21 December 1976 on the approximation of the laws of the Member States relating to foodstuffs for particular nutritional usesOJ No L 26, 31. 1. 1977, p. 55., as last amended by Directive 85/7/EECOJ No L 2, 3. 1. 1985, p. 22., has been amended on a number of occasions; whereas, on the occasion of new amendments, the said Directive should, for reasons of clarity, be redrafted;Whereas the adoption of Directive 77/94/EEC was justified by the fact that the differences between national laws relating to foodstuffs for particular nutritional uses impeded their free movement, may have created unequal conditions of competion, and thus had a direct impact on the establishment and functioning of the common market;Whereas the approximation of national laws presupposed, in an initial stage, the drawing-up of a common definition, the determination of measures enabling the consumer to be protected against fraud concerning the nature of these products and the adoption of rules to be complied with in labelling the products in question;Whereas the products covered by this Directive are foodstuffs the composition and preparation of which must be specially designed to meet the particular nutritional requirements of the persons for whom they are mainly intended; whereas it may be necessary, therefore, to provide for derogations to the general or specific provisions applicable to foodstuffs in order to achieve the specific nutritional objective;Whereas, although foodstuffs intended for particular nutritional uses which are the subject of specific provisions can be efficiently monitored on the basis of the general rules for monitoring all types of foodstuffs, this is not always the case for those foodstuffs in respect of which no such specific provisions exist;Whereas for the latter the usual means available to the monitoring bodies might not in certain cases enable them to check whether a foodstuff actually has the particular nutritional properties attributed to it; whereas it is necessary therefore to provide that, where necessary, the person responsible for placing that foodstuff on the market should assist the monitoring body in carrying out its activities;Whereas the current state of development of Community rules on additives means that it is not possible, in the framework of this Directive, to adopt provisions on the use of additives in foodstuffs intended for particular nutritional uses if they do not belong to one of the groups mentioned in Annex I; whereas this question should therefore be re-examined in due course;Whereas the drawing-up of specific Directives implementing the basic principles of Community rules and amendments thereto are implementing measures of a technical nature; whereas their adoption should be entrusted to the Commission in order to simplify and expedite the procedure;Whereas in all cases where the Council empowers the Commission to implement rules relating to foodstuffs intended for human consumption, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Committee for Foodstuffs, set up by Decision 69/414/EECOJ No L 291, 19. 11. 1969, p. 9.;Whereas this Directive does not affect the time limits within which the Member States must comply with Directive 77/94/EEC,HAS ADOPTED THIS DIRECTIVE:
Article 11.This Directive concerns foodstuffs for particular nutritional uses.2.(a)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.(b)A particular nutritional use must fulfil the particular nutritional requirements:(i)of certain categories of persons whose digestive processes or metabolism are disturbed; or(ii)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(iii)of infants or young children in good health.
Article 21.The products referred to in Article 1 (2) (b) (i) and (ii) may be characterized 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 these 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.3.However, in accordance with provisions to be adopted according to the procedure provided for in Article 13, it shall be possible for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability.The aforesaid provisions may lay down the arrangements for indicating this suitability.
Article 31.The nature or composition of the products referred to in Article 1 must be such that the products are appropriate for the particular nutritional use intended.2.The products referred to in Article 1 must 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 41.The specific provisions applicable to the groups of foods 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), by the Council acting in accordance with the procedure laid down in Article 100a,in the case of the other points, in accordance with the procedure laid down in Article 13.Provisions likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food, set up by Decision 74/234/EECOJ No L 136, 20. 5. 1974, p. 1..1a.To enable foodstuff 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 Scientific Committee for Food and in accordance with the procedure laid down in Article 13, authorize 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 referred to in Annex I.If necessary, the Commission may add in the authorization decision labelling rules relating to the change in composition.2.A list of substances with specific nutritional purposes such as vitamins, mineral salts, amino acids and 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, shall be adopted in accordance with the procedure laid down in Article 13.
Article 4aRules for the use of terms concerningthe reduction or absence of sodium or salt (sodium chloride, table salt) content,the absence of gluten,which may be used to describe the products referred to in Article 1, shall be adopted in accordance with the procedure laid down in Article 13.
Article 4bBefore 8 July 2002, the Commission shall, after consulting the Scientific Committee for Food, 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 discorders (diabetes).In the light of the conclusions of this report, the Commission shall either, in accordance with the procedure laid down in Article 13, proceed with the preparation of the special provisions concerned or shall present, in accordance with the procedure laid down in Article 95 of the Treaty, any appropriate proposals for amendments to this Directive.
Article 5Conditions 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 may be adopted in accordance with the procedure laid down in Article 13.
Article 61.The labelling and the labelling methods used, the presentation and the advertising of the products referred to in Article 1 must not attribute properties for the prevention, treatment or cure of human disease to such products or imply such properties.Derogations from the first subparagraph may be provided for in accordance with the procedure laid down in Article 13 in exceptional and clearly defined cases. 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 71.Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffsOJ No L 33, 8. 2. 1979, p. 1., as last amended by Directive 89/395/EECOJ No L 186, 30. 6. 1989, p. 17., shall apply to the products referred to in Article 1, under the conditions set out below.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 referred to in Article 1 (2) (b) (iii), this 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 must 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, these 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 81.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, however, permit derogations from these provisions for purposes of the retail trade provided that the product is accompanied by the particulars provided for in Article 7 at the time when it is put on sale.
Article 9To 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:1.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.2.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.3.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) together with the information provided for in Article 7 (3) (a). If such work is contained in a readily available publication, a mere reference to this publication shall suffice.4.Member States shall communicate to the Commission the identity of the competent authorities within the meaning of this Article and any other useful information on them.The Commission shall publish this information in the Official Journal of the European Communities.Detailed rules for implementing this paragraph may be adopted in accordance with the procedure laid down in Article 13.5.Before 8 July 2002 and every three years thereafter, the Commission shall send the European Parliament and the Council a report on the implementation of this Article.
Article 101.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 111.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) 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, consult the Member States within the Standing Committee for Foodstuffs, 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 initiate the procedure laid down in Article 13 for the adoption of appropriate measures.
Article 121.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 particular nutritional uses 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 Standing Committee for Foodstuffs, 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 initiate the procedure laid down in Article 13 with a view to adopting those amendments. The Member State which has adopted safeguard measures may in that event retain them until the amendments have been adopted.
Article 131.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 178/2002OJ L 31, 1.2.2002, p. 1., hereinafter referred to as "the Committee".2.Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/ECCouncil Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23). 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.The Committee shall adopt its rules of procedure.
Article 14Directive 77/94/EEC is hereby repealed.References to the repealed Directive shall be construed as references to this Directive and are to be read in accordance with the correlation table set out in Annex II.
Article 151.Member States shall amend their laws, regulations and administrative provisions in such a way as:to permit trade in products complying with this Directive not later than 16 May 1990,to prohibit trade in products not complying with this Directive with effect from 16 May 1991.They shall forthwith inform the Commission thereof.2.Paragraph 1 shall not affect those national provisions which in the absence of the Directives referred to in Article 4 apply to certain groups of foodstuffs intended for particular nutritional uses.
Article 16This Directive is addressed to the Member States.
nullANNEX IGroups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific Directives:It is understod that products already on the market when Directive is adopted will not be affected by it.1.Infant formulae and follow-on formulae2.Processed cereal-based foods and baby foods for infants and young children3.Food intended for use in energy-restricted diets for weight reduction4.Dietary foods for special medical purposes5.Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen;Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by a specific DirectiveIt is understod that products already on the market when Directive is adopted will not be affected by it., dependant on the outcome of the procedure described in Article 4b:6.Foods for persons suffering from carbohydrate-metabolism disorders (diabetes).ANNEX IICORRELATION TABLE
Directive 77/94/EECThis Directive
Article 1 (1)Article 1 (1)
Article 1 (2)Article 2 (2)
Article 1 (3)
Article 2 (1)Article 3 (1)
Article 2 (2) first subparagraphArticle 2 (1)
Article 2 (2) second subparagraph
Article 2 (3)Article 2 (2)
Article 2 (4)Article 2 (3)
Article 3Article 3 (2)
Article 4
Article 4 (1)Article 6 (1)
Article 4 (2)Article 5
Article 4 (3)Article 6 (2)
Article 5 (1)Article 7 (1)
Article 5 (2) point (a)Article 7 (2)
Article 5 (2) points (b) and (c)Article 7 (3) points (a) and (b)
Article 5 (2) point (d)
Article 5 (2) point (e)Article 7 (4)
Article 5 (3)
Article 6Article 8
Article 9
Article 7 (1)Article 10 (1)
Article 10 (2)
Article 7 (2)
Article 8
Article 11
Article 12
Article 9Article 13
Article 10
Article 11
Article 14
Article 12Article 15
Article 13Article 16
Annex I