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Si COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(92) 210 final 
Brussels, ZS May 1992 
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) 
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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) 
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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 
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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. 
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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 
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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, 
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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. 

ISSN 0254-1475 -z-
COM (92) 210 final 
DOCUMENTS 
EN il 03 
Catalogue number : CB-CO-92-223-EN-C 
ISBN 92-77-44312-X 
Office for Officiai Publications of the European Communities 
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