. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/290 
2 August 2006 
 (06-3717) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Member to Agreement notifying:  EUROPEAN COMMUNITIES
 
If applicable, name of local government involved:   
2. Agency responsible:  Commission of the European Co mmunities. Health & Consumer 
Protection General Directorate  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Food preparations for infant use (HS:1901.10);  ICS 67.230.  
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member States of the European Communiti es (EC) and third countries exporting the 
products concerned to the EC.  
5. Title, language and number of p ages of the notified document:  SANCO Document 
SANCO/2256/2006 Draft Commission Directive on infant formulae and follow-on formulae (50 pages).  This measure has also been notified under TBT.  
6. Description of content:  Background    Commission Directive 91/321/EEC of 14 May 1991 
on infant formulae and follow-on formulae was adopted fifteen years a go, therefore before the 
creation of the WTO Agreement on the Applic ation of SPS measures.  Since then this 
directive has been modified several times as for instan ce in proposals notified in 
G/SPS/N/EEC/66 (25 November 1998) and G/SP S/N/EEC/178 (15 October 2002).  Also, 
since 1991, the scientific knowledge  in this field has improved. 
This proposal :  With a view to clarify this legislation, incorporating new scientific knowledge 
and the ultimate aim of facilitating trade, the proposal notified hereby consolidates in a single 
text all the amendments and at the same time it also changes some existing rules in particular: 
- Nutritient composition (i.e. protein, fats, ca rbohydrates, vitamins, minerals and other 
nutrients); 
- Certain definitions a nd labelling provisions; 
- It introduces a new procedure to amend th e Maximum permitted levels of pesticide 
residues, without any change to the existing trade conditions.  
Timing :  This proposal will enter in application 1 year after its publication. On that date 
Commission Directive 91/321/ EEC of 14 May 1991 on infant formulae and follow-on 
formulae  (OJ L 175, 4.7.1991, p. 35) will be repeal ed and replaced by the text notified hereby.  
7. Objective and rationale: [ X ] food safety,  [   ] animal health,  [ X ] plant protection, 
[   ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests   G/SPS/N/EEC/290 
Page 2  
 
  8. International standard, guideline or recommendation: 
[ X ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [   ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:  Codex Standard for infant formula CODEX 
STAN 72-1981 – the revision of this standard is being discussed in Codex.  The draft 
Commission Directive takes account of latest draft revise d Codex Standard. 
Codex Standard for follow-up formula CO DEX STAN 156-1987 – the draft essential 
composition is revised to take account of the latest scientific advice to the European 
Community.  
9. Relevant documents and language(s) in which these are available:  SANCO document  
SANCO/2256/2006 Draft Commission Directive on infant formulae and follow-on 
formulae .  When adopted it will be published in  the Official Journal available at:  http://eur-
lex.europa.eu  . 
A consolidated version (Ref. date May 2004) of Commission Di rective 91/321/EEC on infant 
formulae and follow-on formulae (OJ L 175, 4.7.1991, p. 35) is available at:
http://eur-lex.europa.eu/LexUriServ /site/en/consleg/1991/L/01991L0321-20040501-en.pdf   
Codex standards are available at:  http://www.codexalimentarius.net/web/index_en.jsp  
10. Proposed date of adoption:  October 2006  
11. Proposed date of entry into force:  20 days after publication in the Official Journal of the 
European Union.  
12. Final date for comments:  45 days from date of notificati on (trade facilitation measure).  
Agency or authority designated to handle comments:  [ X ] National notification 
authority, [   ] National enquiry point, or address, fax number and E-mail address (if 
available) of other body:   
13. Texts available from:  [   ] National notification authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: