Source: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52008PC0003:EN:NOT
Timestamp: 2014-03-09 15:27:48
Document Index: 12163581

Matched Legal Cases: ['Art. 1', 'Art. 1', 'Art. 5', 'Art. 6', 'Art. 7', 'Art. 8', 'Art. 9', 'Art. 1', 'Art. 10', 'Art. 11', 'Art. 12', 'Art. 3', 'Art. 16', 'Art. 1']

EUR-Lex - 52008PC0003 - EN
/* COM/2008/0003 final - COD 2008/0003 */
of document: 16/01/2008
of transmission: 16/01/2008; Forwarded to the Council
end of validity: 06/05/2009; Adopted by 32009L0039
Adopted by 32009L0039 Earlier related instruments:
31989L0398 Proposal to amend Repeal Subsequent related instruments:
ESC Opinion 52008AE0763 EP Opinion 52008AP0432 No amendment proposed Select all documents mentioning this document
Brussels, 16.01.2008
COM(2008) 3 final
2008/0003 (COD)
on foodstuffs intended for particular nutritional uses (Recast)
1. On 1 April 1987 the Commission decided[1] to instruct its staff that all legislative measures should be codified after no more than ten amendments, stressing that this was a minimum requirement and that departments should endeavour to codify at even shorter intervals the texts for which they are responsible, to ensure that the Community rules were clear and readily understandable.
2. The codification of 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[2] has been initiated by the Commission and a relevant proposal has been submitted to the legislative authority[3]. The new Directive was to have superseded the various acts incorporated in it[4].
3. In the meantime Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[5] has been amended by Decision 2006/512/EC, which introduced a regulatory procedure with scrutiny for measures of general scope designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, including by deleting some of those elements or by supplementing the instrument by the addition of new non-essential elements.
4. In accordance with the joint statement of the European Parliament, the Council and the Commission[6] on Decision 2006/512/EC, for this new procedure to be applicable to instruments adopted in accordance with the procedure laid down in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.
5. It is therefore appropriate to transform the codification of Directive 89/398/EEC into a recast in order to incorporate the amendments necessary for the adjustment to the regulatory procedure with scrutiny.
ê 89/398/EEC (adapted)
(1) 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[10] has been substantially amended several times[11]. Since further amendments are to be made, it should be recast in the interests of clarity.
ê 89/398/EEC Recital 2 (adapted)
(2) Ö Differences Õ between national laws relating to foodstuffs for particular nutritional uses impede their free movement, may create unequal conditions of competition, and thus Ö have Õ a direct impact on the functioning of the Ö internal Õ market.
ê 89/398/EEC Recital 3 (adapted)
(3) The approximation of national laws Ö presupposes Õ 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.
ê 89/398/EEC Recital 4
ê 89/398/EEC Recital 5
ê 89/398/EEC Recital 6
ê 89/398/EEC Recital 8 (adapted)
(7) Ö Specific provisions applicable to certain groups of foodstuffs should be laid down by means of specific Directives. Õ
ê 96/84/EC Recital 4 (adapted) and Recital 5 (adapted)
(8) A procedure Ö should Õ be laid down which allows the foodstuffs resulting from technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific Directive concerned. Ö However, on the grounds of consumer health protection, marketing authorisation may be granted only after consultation of the European Food Safety Authority. Õ
ê 1999/41/EC Recital 5 (adapted)
(9) Ö Since it Õ is not clear whether an adequate basis exists for specific provisions to be adopted for the group of foods intended for persons suffering from carbohydrate metabolism disorders (diabetes), Ö the Commission should be allowed to adopt or propose the relevant provisions at a later stage, after consultation of the European Food Safety Authority Õ.
ê 1999/41/EC Recital 7
ê 89/398/EEC Recital 8
(12) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission[12].
(13) Power should be conferred on the Commission in particular to adopt certain specific Directives, a list of substances with specific nutritional purposes 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, provisions allowing to indicate on foodstuffs for normal consumption that they are suitable for a particular nutritional use, special provisions for foods for persons suffering from carbohydrate metabolism disorders (diabetes), rules for the use of terms concerning the reduction or absence of sodium or salt content or the absence of gluten, which may be used to describe the products, as well as conditions under which reference may be made in labelling, presentation and advertising to a diet or to a category of persons. Since those measures are of general scope and are designed to amend non-essential elements of this Directive or to supplement this Directive by the addition of new non-essential elements, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(14) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to use the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption and amendment of a list of substances with specific nutritional purpose 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, as well as for adoption of amendments to this Directive or to specific Directives when it is established that a foodstuff intended for particular nutritional uses endangers human health although it complies with the relevant specific Directive.
(16) This Directive should be 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,
ê 89/398/EEC
Ö 3. Õ A particular nutritional use must fulfil the particular nutritional requirements:
Ö (a) Õ of certain categories of persons whose digestive processes or metabolism are disturbed; or
Ö (b) Õ 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
Ö (c) Õ of infants or young children in good health.
1. The products Ö covered by Õ Article Ö 1(3)(a) and (b) Õ may be characterised as ‘dietetic’ or ‘dietary’.
(a) the use of the adjectives ‘dietetic’ or ‘dietary’ either alone or in conjunction with other words, to designate these foodstuffs;
However, in accordance with provisions to be adopted ð by the Commission ï, it shall be possible for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability.
Ö Such Õ provisions may lay down the arrangements for indicating this suitability.
1. The specific provisions applicable to the groups of Ö foodstuffs Õ for particular nutritional uses appearing in Annex I shall be laid down by means of specific Directives.
- in the case of point (e), in accordance with the procedure laid down in Article Ö 95 of the Treaty Õ,
- in the case of the other points, ð by the Commission ï. ð 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) of this Directive. ï
Provisions likely to have an effect on public health shall be adopted after consultation of the Ö European Food Safety Authority. Õ
ê 96/84/EC Art. 1 (adapted)
Ö 2. Õ 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 Ö European Food Safety Authority Õ and in accordance with the procedure Ö referred to Õ in Article Ö 15(2) Õ, 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 Ö for groups of foodstuffs for particular nutritional uses Õ referred to in Annex I.
Ö 3. Õ ð The Commission shall adopt ï 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.
ðThose measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted ï in accordance with the ð regulatory ï procedure ð with scrutiny ï Ö referred to Õ in Article Ö 15 Õ ð (3) ï.
ð When necessary, those measures shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(4). ï
ê 1999/41/EC Art. 1 pt. 1 (adapted)
ð The Commission shall adoptï rules for the use of terms concerning the reduction or absence of sodium or salt (sodium chloride, table salt) content Ö or Õ the absence of gluten, which may be used to describe the products referred to in Article 1, shall be adopted.
Before 8 July 2002, the Commission shall, after consulting the Ö European Food Safety Authority Õ, 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 this report, the Commission shall either
Ö (a) Õ in accordance with the procedure laid down in Article 13 proceed with the preparation of the special provisions concerned, or
Ö (b) Õ 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) of this Directive.
ê 89/398/EEC Art. 5 (adapted)
ð The Commission may adopt ï 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 may be adopted.
ðThose measure, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted ï in accordance with the ð regulatory ï procedure ð with scrutiny ï Ö referred to Õ in Article Ö 15 Õ ð (3) ï.
ê 89/398/EEC Art. 6 (adapted)
1. The labelling and the labelling methods used, the presentation and the advertising of the products referred to in Article 1 Ö shall Õ 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 Ö referred to Õ in Article Ö 15(2) Õ in exceptional and clearly defined cases. Derogations may be continued until that procedure has been completed.
ê 89/398/EEC Art. 7 (adapted)
1. Ö Directive 2000/13/EC of the European Parliament and of the Council Õ[13], Ö shall Õ apply to the products referred to in Article 1 Ö of this Directive Õ, under the conditions set out Ö in paragraphs 2, 3 and 4 of this Article Õ.
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 Ö covered by Õ Article Ö 1(3)(c) Õ, this reference shall be replaced by a reference to the purpose for which they are intended.
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’.
ê 89/398/EEC Art. 8 (adapted)
2. Member States may permit derogations from Ö paragraph 1 Õ for purposes of the retail trade provided that the product is accompanied by the particulars provided for in Article Ö 9 Õ at the time when it is put on sale.
ê 89/398/EEC Art. 9 (adapted)
Ö 1. Õ 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:
Ö (a) when Õ 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 Ö ; Õ
Ö (b) where Õ 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 Ö ; Õ
Ö (c) where Õ 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 Ö 9 Õ(3)(a). If such work is contained in a readily available publication, a mere reference to this publication shall suffice.
Ö 2. Õ Member States shall communicate to the Commission the identity of the competent authorities within the meaning of Ö paragraph 1 Õ and any other useful information on them.
The Commission shall publish this information in the Official Journal of the European Ö Union Õ.
Ö 3. Õ Detailed rules for implementing paragraph Ö 2 Õ may be adopted in accordance with the procedure Ö referred to Õ in Article Ö 15(2) Õ.
ê 1999/41/EC Art. 1 pt. 2 (adapted)
Ö 4. Õ Ö Every three years, and for the first time before 8 July 2002 Õ, the Commission shall send the European Parliament and the Council a report on the implementation of this Article.
ê 89/398/EEC Art. 10
ê 89/398/EEC Art. 11 (adapted)
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) Ö and (3) Õ 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 Ö referred to in Article 15(1) Õ, 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 Ö adopt the appropriate measures in accordance with Õ the procedure Ö referred to Õ in Article Ö 15(2) Õ.
ê 89/398/EEC Art. 12 (adapted)
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 Ö referred to in Article 15(1) Õ, 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 Ö adopt those amendments Õ.
ð Those measures, designed to amend non-essential elements of this Directive, shall be adopted ï Ö in accordance with Õ the ð regulatory ï procedure ð with scrutiny ï Ö referred to Õ in Article Ö 15 Õ ð (4) ï.
ê 1882/2003 Art. 3 and Annex III, pt. 15 (adapted)
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 Ö of the European Parliament and of the Council Õ[14], hereinafter referred to as “the Committee”.
2. Where reference is made to this Ö paragraph Õ, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
ð 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. ï
ð 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. ï
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.
ê 89/398/EEC Art. 16
ê 1999/41/EC Art. 1 pt. 3 (adapted)
Ö A. Õ Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific Directives:
Ö B. Õ Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by a specific Directive, dependent on the outcome of the procedure described in Article Ö 6 Õ:
Council Directive 89/398/EEC (OJ L 186, 30.6.1989, p. 27) |
Directive 96/84/EC of the European Parliament and of the Council (OJ L 48, 19.2.1997, p. 20) |
Directive 1999/41/EC of the European Parliament and of the Council (OJ L 172, 8.7.1999, p. 38) |
List of time limits for transposition into national law and application (referred to in Article 16)
Directive | Time-limits for transposition | Permission of trade in products complying with this Directive | Prohibition of trade in products not complying with this Directive |
89/398/EEC | — | 16 May 1990 | 16 May 1991[15] |
1999/41/EC | 8 July 1999 | 8 July 2000 | 8 January 2001 |
Article 1(2)(a) | Article 1(2) |
Article 1(2)(b) | Article 1(3) |
Article 1(2)(b)(i), (ii) and (iii) | Article 1(3)(a), (b) and (c) |
Article 2(2) | Article 2(2) first subparagraph |
Article 2(3) | Article 2(2) second and third subparagraphs |
Article 4(1)(a) | Article 4(2) |
Article 9 introductory words | Article 11(1) introductory words |
Article 9 points 1, 2 and 3 | Article 11(1)(a), (b) and (c) |
Article 9 point 4, first and second sentence | Article 11(2) |
Article 13(3) | – |
– | Article 15(3) and (4) |
Articles 14 and 15 | – |
– | Articles 16 and 17 |
Annex II | – |
– | Annexes II and III |
[3] COM(2004) 290 final.
[10] OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
[11] See Annex II, Part A.
[13] Ö OJ L 109, 6.5.2000, p. 29 Õ.
[15] In accordance with Article 15 of Directive 89/398/EEC:
“1. Member states shall amend their laws, regulations and administrative provisions in such way as:
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.”