COMMISSION OF THE EUROPEAN COMMUNITIES 
COM(91) 441 final 
Brussels,14 November 1991 
Proposal for a 
COUNCIL DIRECTIVE 
on infant formulae and follow-on formulae 
intended for export to third countries 
,M, 
mM' &*&** m.4 
srllïij Proposal for a 
COUNCIL RESOLUTION 
on the marketing practices for breast-milk substitutes in 
developing countries by Community-based manufacturers 
«S (presented by the Commission) 
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EXPLANATORY MEMORANDUM 
In conformity with article 4 of Council Directive 89/398/EEC on the 
approximation of the laws of the Member States relating to foodstuffs 
Intended for particular nutritional uses(1), Commission Directive 
91/321/EEC(2) on Infant formulae and follow-on formulae was adopted 
on 14.5.1991. This Commission Directive lays down, amongst others, 
provisions relating to the composition and the labelling of these products. 
Given the section of the population for which these products are intended, 
It is felt that the abovementioned particular rules should also apply to 
products Intended for export to third countries. 
Taking into account the framework of Community legislation within which 
these rules have to be adopted and for the sake of coherence, all the 
abovementIoned rules applicable to products Intended for export to third 
countries are Included In one legal measure. 
Commission Directive 91/321/EEC lays down in addition provisions relating 
to advertising and other marketing practices. The Community cannot regulate 
such practices taking place In third countries nor indeed can effectively 
control them. In relation to this point however it should be noted that a 
proposal for a Council resolution relating to marketing practices for 
breast milk substitutes in developing countries by Community based 
manufacturers is also being put forward by the Commission. 
(1) O.J. N° L 186 Of 30.6.1989, p. 27 
(2) O.J. N° L 175 of 4.7.1991, p. 35 
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Proposal for a 
CounclI 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 la id-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 
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 
Allmentarlus ; 
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. 
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. 
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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Proposal for a 
COUNCIL RESOLUTION 
on the marketing practices for breast-milk substitutes In 
developing countries 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 render 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 
Substitutes; 
Whereas a considerable volume of these products are sold to developing 
countries by Community-based manufacturers; 
Whereas it is considered very Important that marketing practices In 
developing 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 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, In so far as It is able, to the 
application of appropriate marketing practices for breast-milk 
substitutes In developing countries. 
2. For the Implementation of point 1, the Commission will instruct Its 
delegations In the developing countries to serve as contact points for 
the competent authorities. Any complaints or crIt is Isms 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 
COM(91) 441 final 
DOCUMENTS 
EN 15 
Catalogue number : CB-ÇO-91-488-EN-C 
ISBN 92-77-77157-7 
OfQce for Official Publications of the European Communities 
L-2985 Luxembourg