CELEX: 51992PC0210(02)
Language: en
Date: 1992-05-25
Title: Amended draft COUNCIL RESOLUTION on the marketing practices for breast-milk substitutes in third countries by Community- based manufacturers

COMMISSION OF THE EUROPEAN COMMUNITIES
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                                                               COM(92) 210 final
                                                               Brussels, ZS May 1992
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                                       Amended proposal for a
                                          COUNCIL DIRECTIVE
                             on infant formulae and follow-on formulae
                               intended for export to third countries
                                            Amended draft
                                         COUNCIL RESOLUTION
                    on the marketing practices for breast-milk substitutes in
                         third countries by Community-based manufacturers
                     (presented by the Commission pursuant to Article 149(3)
                                         of the EEC Treaty)
Si
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                               Explanatory Note
 In November 91 the Commission submitted to the Council a proposal for a
Council Directive on infant formulae and follow-on formulae Intended for
export to third countries and a draft Council Resolution on the marketing
practices for breast-milk substitutes In developing countries by Community-
based manufacturers* 1 ).
These proposals were based on article 113 of the Treaty which did not
foresee consultation of the European Parliament. However the latter was
consulted and delivered its opinion on the subject* 2 *. It approved the
Commission proposals subject to a number of amendments.
Concerning the directive the Commission accepted the principle of
amendments 1 and 14 to ensure that no products other than infant formulae
exported to third countries should be represented as suitable for infants
of 4-6 months of age and parts of amendment 4 to ensure that the labelling
should be in an appropriate language and should be such as to avoid
confusion between Infant formulae and follow-on formulae. It could not
accept amendment 2 which was not in agreement with the advice of the
Scientific Committee for Food and amendment 3 and parts of amendment 4
which proposed additional labelling requirement already covered by
Community legislation. It also rejected amendment 15 because It could not
legislate on practices taking place In the territory of third countries and
amendment 16 which referred to products not regulated at Community level.
Concerning the proposal for a Resolution it accepted amendments 6, 7 and 9
with some drafting modifications to extend the application of the proposed
Resolution to all non-Community countries and to strengthen the Community
committment. The Commission did not accepted amendments 8 and 10 referring
to voluntary agreements between Member States and Industry over which It
would have no control, amendment 11 in order to preserve Its independence
and freedom of action, amendment 12 because it would not be appropriate
 institutionally and amendment 13 because It would Impose unnecessary burden
for the limited Commission resources.
 In response to this opinion the Commission has decided to amend both Its
abovementloned proposals.
For practical reasons consolidated texts are presented where the amendments
are under Iined.
(1)
(2)
 ---pagebreak---                                     - 3 -
                         Amended proposal for a
                            COUNCIL DIRECTIVE
                 on Infant formulae and follow-on formulae
                  intended for export to third countries.
THE COUNCIL OF THE EUROPEAN COMMUNITIES
Having regard to the Treaty establishing the European Economic Community
and in particular Article 113 thereof,
Having regard to the proposal from the Commission* 1 *,
Whereas Community rules concerning   infant formulae and follow-on formulae
are lald-down In Commission directive 91/321/EEC* 2 * ;
Whereas given the nature of the products In question It is desirable that
Community rules or International standards relating to their composition
are made applicable to such products intended for export to third
countries •,
Whereas In order to prevent  Inappropriate use of these products which could
prejudice the health of Infants it Is also desirable to extend the
application of the Community rules on labelling of infant formulae and
follow-on formulae to those products Intended for export to third
countrles,
HAS ADOPTED THIS DIRECTIVE :
                                  Article 1
This Directive concerns infant formulae and follow-on formulae, as defined
by article 1.2.c. and d of Directive 91/321/EEC, Intended for export to
third  countries.
(1)
(2) O.J. N° L 175 Of 4.7.1991, p. 35
 ---pagebreak---                                    - 4 -
                                 Article 2
1.   Member States shall ensure that the products referred to In article 1
     may be exported from the Community only If they are In conformity with
     this directIve.
2.   No product other than Infant formulae may be represented as suitable
     for satisfying by Itself the nutritional requirements of normal
     healthy Infants during the first four to six months of life.
3.   In addition the products referred to In article 1 must be In
     conformity :
     a) with the provisions of articles 3, 4, 5 and 6 of Directive
        91/321/EEC or with relevant applicable world standards established
        by Codex Alimentarius ;
     b) with the provisions of article 7 paragraphs 2 to 6 of Directive
        91/321/EEC
     unless otherwise requested or stipulated by provisions established by
     the importing country.
4.   They shall be labelled in an appropriate language and in such a way as
     to avoid any risk of confusion between Infant formulae and follow-on
     formulae.
                                 Article 3
Member States shall take the necessary measures to comply with this
Directive. They shall forthwith Inform the Commission thereof. Those
measures shall be applied in such a way as to :
     permit exports of products complying with this Directive, by 1
     December 1992 ;
     prohibit exports of products which do not comply with this Directive,
     with effect from 1 June 1994.
 ---pagebreak---                                    - 5 -
When Member States adopt these provisions, they shall contain a reference
to this Directive or shall be accompanied by such reference at the time of
their official publication. The procedure for such reference shall be
adopted by the Member States.
                                 Article 4
This Directive Is addressed to the Member States.
Done at                               For the Council
 ---pagebreak---                                       - 6 -
                                 Amended draft
                              rnitMf.ll RESOLUTION
          on the marketing practices for breast-milk substitutes in
              third countrles by Community-based manufacturers.
THE COUNCIL OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Economic Community,
Whereas Council Directive .../.../EEC on infant formulae and follow-on
formulae Intended for export to third countries renders applicable to such
products a number of Community provisions relating to the composition and
the labelling of infant formulae and follow-on formulae;
Whereas in May 1981 the 34th World Health Assembly adopted as a
recommendation the International Code of Marketing of Breast-milk
Subst itutes;
Whereas a considerable volume of these products are sold to thIrd countrles
by Community-based manufacturers;
Whereas It is considered very Important that marketing practices In third
countries should not discourage mothers from breastfeeding;
Whereas the application of the International Code provides without doubt an
excellent way to achieve this In these countries;
Whereas the Community cannot  legislate for these countries; whereas It is
nevertheless necessary to encourage compliance with the International Code
of Marketing of Breast-Milk substitutes when these products are placed on
sale In export markets, Insofar as this does not conflict with the
provisions In force In the countries concerned;
Whereas the Community can offer an effective support to the competent
authorities of these countries in their efforts to apply the International
Code in their territory,
 ---pagebreak---                                    - 7 -
HAS ADOPTED THE FOLLOWING RESOLUTION :
1.   The Community will contribute to the application of appropriate
     marketing practices for breast-milk substitutes in third countries.
2.   For the implementation of point 1, the Commission will instruct its
     delegations In third countrles to serve as contact points for the
     competent authorities.  Any complaints or critlsisms with respect to
     the marketing practices of a manufacturer based in the Community could
     be notified to them.
3.   The Commission will be ready to examine such cases and to assist in
     the search for a satisfactory solution for all parties concerned.
4.   This resolution shall be communicated by the Commission to the
     countries concerned through the official channels.
 ---pagebreak---  ---pagebreak---                                                                       ISSN 0254-1475
                                       -z-                     COM (92) 210 final
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