No C 303/22 Official Journal of the European Communities 25. 11. 85 
Opinion on the proposal for a Council Directive on the approximation of the laws of the Member 
States relating to infant formulae and follow-up milks (') 
(85/C 303/09) 
On 18 January 1985 the Council decided to consult the Economic and Social Committee, under 
Article 100 of the Treaty establishing the European Economic Community, on the abovementioned 
proposal. 
The Section for Protection of the Environment, Public Health and Consumer Affairs, which was 
responsible for preparing the Committee's work on the subject, adopted its opinion on 9 July 1985, 
in the light of the report by Mr Hilkens. 
At its 229th plenary session (meeting of 25 September 1985) the Economic and Social Committee 
adopted the following opinion by 48 votes in favour, with 19 against and six abstentions. 
1. General comments 
1.1. The Committee approves the proposal of the 
Commission for a Directive to harmonize Member States' 
legislation with regard to infant formulae and follow-up 
milks, subject to the observations set out below. 
1.2. The Committee is pleased to note that in the 10th 
recital of the preamble to the proposal it is stated that in an 
effort to provide better protection for the health of infants, 
the rules of composition and labelling must take account of 
the principles and aims of the International Code of 
Marketing of Breast-Milk Substitutes (WHO code) 
adopted by the 34th World Health Assembly in May 1981. 
1.2.1. The fact that the Community and all its Member 
States have already accepted the WHO code in the form of a 
recommendation is an additional reason why the relevant 
legislation should be harmonized as far as possible with the 
WHO code. 
1.2.2. The Committee has taken note of the proposed 
alternative voluntary IDACE code put forward by the 
National Associations of Manufacturers of Dietetic Foods 
of the EEC, but expresses a preference for the WHO code. 
1.2.2.1. The Committee stresses that the preamble to the 
IDACE code states that 'this voluntary code is a minimum 
requirement, which does not exclude specific national 
measures existing or being adopted. This code does not 
take precedence over national or EEC legislation'. 
1.2.3. Furthermore, the Committee is aware that the 
FAO/WHO Codex Committee on Foods for Special 
Dietary Uses (on which the Community as a whole and 
most of the Member States as separate entities are 
represented), has already introduced standards for infant 
formulae and is in process of drawing up a proposal on 
standards for follow-up food for older infants and young 
children. 
1.2.3.1. These appear to cover a broader field than the 
proposal under examination, and the Committee requests 
the Commission to examine the Codex texts, and if 
necessary, revise its own proposal to ensure that a 
harmonized approach is adopted. 
(!) OJ No C 28, 30. 1. 1985, p. 3. 1.3. On the important subject of labelling of breast-milk 
substitutes, the label should include firstly, some form of 
identification of the product, in particular distinguishing it 
from powdered whole milk or other types of powdered 
milk, and secondly, only information and guidance for the 
proper use of the product, and not material of a 
promotional nature. 
1.3.1. The Committee is concerned that such inform­
ation be presented in a form most likely to be understood by 
the vast majority of mothers, bearing in mind the low 
literacy levels which still exist among certain categories of 
the population both within the Member States, and in the 
Third World. The risks involved in not following 
instructions properly can be particularly serious. 
1.3.2. Consequently while the Committee is sym­
pathetic to the concept included in the WHO code that 
pictures of infants should not be used to idealize breast-
milk substitutes, although 'graphics for easy identification' 
are permitted, nevertheless points out that in a low-literacy 
market graphical pictures of babies may well be the only 
means of clearly illustrating how the product should be 
used. 
1.3.3. Nevertheless, the Committee considers that 
certain of the more important provisions of the WHO code 
should be incorporated into the proposed Directive, and 
specifically that the following should appear on the labels: 
(a) the words 'Important Notice' or their equivalent; 
(b) a statement of the superiority of breast feeding, couched 
in terms which would not induce a sense of guilt in 
mothers who cannot breast feed; 
(c) a statement that the product should be used only on the 
advice of a health worker; 
(d) instructions for appropriate preparation and a warning 
against the risks of improper preparation. 
1.4. With regard to Article 5 of the WHO code which 
covers advertising and other forms of promotion to the 
general public and mothers, the Committee thinks that a 
general ban on activity of this nature — as recommended in 
25. 11. 85 Official Journal of the European Communities No C 303/23 
the code — is desirable. However, if it is true as indicated 
by the Commission, that there may be constitutional 
objections in some Member States to such a ban, the 
Committee considers that consultations must be held with 
baby-food manufacturers in order to obtain through 
producer-consumer 'dialogue' an agreement with them on 
a general ban on advertising in conformity with the 
provisions of the WHO code. 
1.5. The Committee agrees in general with the ma­
ximum and minimum essential composition requirements 
listed in the Annexes, but notes that the provisions of the 
Codex Alimentarious are different in some cases. There­
fore, the Committee asks the Commission to look into this 
problem paying particular attention to protein content. 
1.6. The Committee reminds the Commission that on­
going consultations in respect of this proposal should be 
maintained with WHO and UNICEF. 
2. Specific comments 
2.1. Article 1 (1) 
The Committee notes that there has been disagreement at 
international level on the precise meaning of the term 
'follow-up milk'. The report of the Scientific Committee 
for Food (14th series) , uses this term but the Codex 
Committee on Foods for Special Dietary Uses has proposed 
the term 'follow-up food' (as distinct from follow-up milk), 
with the proviso that individual countries may add any 
appropriate designation in accordance with national usage. 
2.1.2. The Committee therefore requests the Commis­
sion to use terminology which is more readily understood 
by the consumer than the terms proposed. 
2.2. Article 1 (2) 
2.2.1. The Committee likewise notes that there has been 
disagreement at international level on the precise age at 
Done at Brussels, 25 September 1985. which the switchover from breast feeding or a complete 
diet of infant food to other sorts of food should take place. 
2.2.2. The Committee notes, however, that the recom­
mendation of the Scientific Committee for Food (14th 
series), taken up in the Commission's proposal, has been to 
specify a range of four to six months. 
2.2.3. The Committee further understands that the 
Codex Committee now proposes to alter its draft proposal 
to adopt 'four to six months' as the switchover age rather 
than 'six months'. 
2.2.4. The Committee requests the Commission to 
ensure that the final text of its proposal is in conformity 
with that of the Codex. 
2.3. Article 9 (1) 
2.3.1. It should also be ensured that the official 
definitions are used at all times. Trade names, if used, 
should not appear in isolation but in conjunction with the 
description of the product. 
Article 9 (2) (a) and (c) 
2.3.2. The word 'particular' before the words 'nutri­
tional use' should be deleted in both these subparagraphs, 
as it is superfluous in the context. 
Article 9 (2) (f) 
2.3.3. This subparagraph should be amended to take 
cognizance of the observations in paragraphs 1.3 to 1.3.3 of 
the 'General comments'. 
Article 9 (4) and (5) 
2.3.4. These subparagraphs should be reworded to 
emphasize that the labelling should only contain factual 
information and should not make any claims idealizing or 
promoting the product (Article 9 (4) or about special 
composition (Article 9 (5)). 
The Chairman 
of the Economic and Social Committee 
Gerd MUHR 
No C 303/24 Official Journal of the European Communities 25. 11. 85 
APPENDIX 
to the opinion of the Economic and Social Committee 
A. Rejected amendments 
The following amendments to the Section opinion, tabled in accordance with the Rules of Procedure, were 
rejected by the Committee in the course of the discussions: 
Point 1.2.2 
Reword the end of the paragraph to read as follows: 
'. . ., dietetic-foods of the EEC, the aim of the IDACE being to implement the principles and objectives of the 
WHO code in a way which is consistent with the economic and social conditions within the EEC 
Reasons 
The draft opinion risks confusing two codes which share neither the same purpose nor the same scope. The 
WHO code is addressed to national authorities, in particular to health authorities; it is uniformly applicable by 
the fact that it has been incorporated into national legislations. 
The IDACE code is a convention which is voluntarily observed by the industries concerned and which takes up 
(as is explicitly stated in Annex HI to the draft proposal) the principles and objectives of the WHO code. 
Whereas the WHO code is universally applicable, the IDACE code has been adapted to the specific conditions of 
the EEC. 
This amendment seeks purely to clarify matters. 
Result of the vote 
For: 29. Against: 44. Abstentions: 7. 
Point 1.3 
Third and fourth lines, delete: 
'. . . and not material of a promotional nature'. 
Reason 
Superfluous. Promotional material on labels is already prohibited. 
Result of the vote 
For: 32. Against: 51. Abstentions: 4. 
Point 1.3.2 
Delete this point. 
Reasons 
A picture of a baby (or of a mother) on the label of a product is a particularly persuasive form of publicity, 
especially for people who are illiterate. To use such a picture would go against the concern expressed in point 
1.3 that the label should contain no promotional material, in line with Article 4 of the proposal. 
Result of the vote 
For: 9. Against: 47. Abstentions: 23. 
Point 1.3.3 
Replace paragraph (c) by: 
'a statement to the effect that your health advisor should be asked for his opinion on the feeding of your child'. 
Reasons 
Paragraph (c) of point 1.3.3 of the draft opinion is misleading. Preparations for infants are food not medicines. 
There is therefore no need for such a restrictive provision which might throw mothers into a panic. 
Result of the vote 
For: 26. Againts: 41. Abstentions: 12. 
25. 11. 85 Official Journal of the European Communities No C 303/25 
Point 1.4 
Delete. 
Reasons 
Baby-food manufacturers already support the proposed IDACE code. The industry already operates a 
voluntary ban on advertising, so there is no need for legislation. 
Moreover, in some countries there are constitutional objections to such a ban. However, if the IDACE code 
were incorporated in the proposed Directive, there would be no objection. 
Result of the vote 
For: 22. Againts: 48. Abstentions: 4. 
Point 1.4 
Delete the second sentence of the point: 
'However ... of the WHO code'. 
Reasons 
The reference to constitutional objections is unjustified, or at least somewhat belated; the Member States have 
accepted the WHO-UNICEF code without these objections. 
Result of the vote 
For: 31. Against: 34. Abstentions: 9. 
Article 9 (4) 
Replace by the following: 
'Article 9 (4) 
The word 'adapted' in the first paragraph of Article 9 (4) should be deleted'. 
Reasons 
There are objections about the word 'adapted' not being allowed on the label. 'Adapted' surely means that the 
food is adapted to the needs of infants, as opposed to 'unadapted' cows' milk. 
Result of the vote 
For: 28. Against: 37. Abstentions: 8. 
B. Change made to the text 
The following text of the Section's opinion has been deleted following the acceptance of an amendment 
proposed during the Committee's debate. 
Article 9 (6) 
'This paragraph should be revised to apply the requirements of paragraph 3, in addition to those of paragraphs 
4 and 5 to subparagraphs 6 (a) and 6 (b)'.