Amended draft COUNCIL RESOLUTION on the marketing practices for breast-milk substitutes in third countries by Community- based manufacturers
Date: 1992-05-25
Institutions: European Commission
Subjects: extra-EU trade, marketing, mother's milk

COMMISSION OF THE EUROPEAN  COMMUNITIES 

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) 

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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) 

-  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 

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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. 

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