CELEX: 51995PC0588
Language: en
Date: 1995-11-29
Title: Amended proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending Directive 89/398/EEC on the approximation of the laws of Member States relating to foodstuffs intended for particular nutritional uses

COMMISSION OF THE EUROPEAN COMMUNITIES
                                                     Brussels, 29.11.1995
                                                      COM(95) 588 final
                                                      94/0076 (COD)
                               Amended proposal for a
          EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE
amending Directive 89/398/EEC on the approximation of the laws of Member States relating to
                       foodstuffs intended for particular nutritional uses
           (presented by the Commission pursuant to Article 189 a (2)
                                   of the EC-Treaty)
 ---pagebreak---  ---pagebreak---                                        Explanatory memorandum
 In response to the opinion of the European Parliament1 delivered on 11 October 1995 on the
 proposal for a European Parliament and Council Directive amending Directive 89/398/EEC on
the approximation of the laws of Member States relating to foodstuffs intended for particular
nutritional uses2 which aimed to modify the list of groups of foods for particular nutritional uses
 for which specific directives shall be adopted, and in accordance with article 189A of the EC
Treaty, the Commission has decided to amend the above mentioned proposal.
The Commission has accepted the amendments relating to :
- the introduction of a new recital referring to the agreement on a "modus vivendi" between the
    European Parliament, the Council and the Commission (amendment 1).
- the inclusion of foods for persons suffering from carbohydrate metabolism disorders
    (diabetes) in the groups of foods listed in Annex I for which specific provisions will be laid
    down by specific directives (amendment 18 in part, amendment 16 in part).
- defining the conditions for the use of the terms low-sodium, reduced-sodium and sodium-free
    and gluten-free for dietetic foods where the scientific basis for doing so is available (the
    principle of amendment 17).
- recalling in the recitals that it remains possible to harmonise other rules for other groups of
    foods for particular nutritional uses (amendment 4)
The Commission did not accept the amendments concerning :
- the inclusion of low-sodium foods and gluten-free foods in the groups of foods listed in
    Annex I for which specific directives shall be adopted (amendments 18 in part, amendment
    without number on a separate vote, amendment 16 in part). The Commission maintains that
    such specific directives are not necessary for the reasons it has explained in its original
    proposal and because in addition now it has accepted to define the conditions under which the
    terms relating to sodium and gluten content can be used.
- the pesticide levels and residues in infant formulae and baby foods because this is not the
    appropriate directive for such references to be made (amendments 9 and, 10 and 16).
- the addition of a new paragraph in article 4 stating that new groups of foods for particular
    nutritional uses may be added in Annex I (amendment 5). This is the case now and would be
    superfluous to have it in the articles. An amendment (n° 4) for a recital on this point has been
    accepted.
1
  O.J
2
  O.J. N° C108 16.04.1994, p. 17
                                               I
 ---pagebreak--- creation of a new Annex la comprising allowed claims for dietetic foods (amendment 6).
There are no suggestion for any specific claims to appear in that Annex, therefore the
Commission considers it unnecessary.
                                     3
 ---pagebreak--- In response to the opinion of the European Parliament3 delivered on 11 October 1995 on the
proposal for a European Parliament and Council Directive amending Directive 89/398/EEC on
the approximation of the laws of the Member States relating to foodstuffs intended for particular
nutritional uses4 and in accordance with Article 189A of the EC Treaty, the Commission has
decided to amend the above proposal as follows :
Original proposal                               Amended proposal
                                                1. The following new recital is added after the
                                                first recital :
                                                Whereas an agreement on a 'modus vivendi'
                                                between the European Parliament, the Council
                                                and the Commission concerning the
                                                implementing measures for acts adopted in
                                                accordance with the procedure laid down in
                                                Article 189b of the EC Treaty was reached on
                                                20 December 1994
                                                2. The second recital is amended as follows :
Whereas to date such a Directive relating to    Whereas to date such a Directive relating to
infant formulae and follow-on formulae has      infant formulae and follow-on formulae has
been adopted;                                   been adopted;
whereas there are reasons relating to public    whereas there are reasons relating to public
health for adopting specific provisions, in     health for adopting specific provisions, in
accordance with Article 4 of Directive          accordance with Article 4 of Directive
 89/398/EEC, for cereal based foods and baby    89/398/EEC, for cereal based foods and baby
 foods intended for infants and young children, foods intended for infants and young children,
 foods for weight control diets and foods for   foods for weight control diets, foods for
 special medical purposes foreseen in Annex I   special medical purposes and foods for
 to the said Directive;                         persons       suffering   from    carbohydrate
                                                 metabolism disorders (diabetes"! foreseen in
                                                 Annex I to the said Directive.
 3
    O.J
  4
    O.J. N°C108 16.04.1994, p. 17
 ---pagebreak---                                                3. The third recital is amended as follows :
Whereas the same imperative reasons for        Whereas the same imperative reasons for
adopting specific provisions for the other     adopting specific provisions for the other
groups listed in Annex I to Directive          groups listed in Annex I to Directive
89/398/EEC namely low-sodium foods,            89/398/EEC namely low-sodium foods,
including low-sodium or sodium-free dietary    including low-sodium or sodium-free dietary
salts, gluten-free foods, foods intended to    salts, gluten-free foods, and foods intended to
meet the expenditure of intense muscular       meet the expenditure of intense muscular
effort, especially for sportsmen and foods for effort, especially for sportsmen cannot be put
persons     suffering     from    carbohydrate forward; whereas such products can be
metabolism disorders (diabetes) cannot be put  adequately marketed and be efficiently
forward; whereas such products can be          monitored officially under the general
adequately marketed and be efficiently         provisions of Directive 89/398/EEC provided
monitored officially under the general         that the conditions for the use of certain terms
provisions of Directive 89/398/EEC.            used to indicate the particular nutritional
                                               property of products arc defined-
                                               4. The following new recital is added after
                                                   the last recital
                                               Whereas it remains possible tô harmonise at
                                               Community level rules for other groups of
                                               foods for particular nutritional uses, as
                                               necessary, in the interest of consumer
                                               protection and free movement of such
                                               foodstuffs,
                                               Article \
                                               Directive 89/398/EEC is amended as follows :
                                                1. The following article 4a is inserted in
                                                   directive S9/398/EEC
                                                   "Article 4a
                                                   The conditions under which the terms
                                                   concerning
                                                   - reduction or absence of sodium (salt)
                                                      content
 ---pagebreak---                                                           - absence of gluten (gluten free)
                                                          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"
Annex I to directive 89/398/EEC_ojUhe_ 2. Annex I to directive 89/398/EEC is hereby
approximation of the laws of the Member                   replaced by the following :
States relating to foodstuffs intended for
particular nutritional uses is hereby
replaced by the following :
"ANNEX 1                                                  "ANNEX 1
Groups of foods for particular nutritional                Groups of foods for particular nutritional
uses for which specific provisions will be                uses for which specific provisions will be
laid down by specific directives1                         laid down by specific directives1
1.   Infant formulae and follow-on formulae               1. Infant formulae and follow-on formulae
2.   Cereal based foods and baby foods                    2. Cereal based foods and baby foods
3.   Food intended for weight control diets               3. Food intended for weight control diets
4.   Dietary foods for special medical                    4. Dietary foods for special medical
     purposes                                                purposes
                                                          5. Foods for persons suffering from
                                                             carbohydrate metabolism disorders
                                                             (diabetes)
It is understood that products already on the market when 1   It is understood that products already on the market
the Directive is adopted will not be affected by it"         when the Directive is adopted will not be affected by
                                                 C
 ---pagebreak---                                                                     ISSN 0254-1475
                                                             COM(95) 588 final
                                              DOCUMENTS
EN                                                                         06 10
                                     Catalogue number : CB-CO-95-621-EN-C
                                                              ISBN 92-77-96412-X
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