. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/312 
26 July 2007  
 (07-3206) 
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 Communities. Health & Consumer 
Protection Directorate-General  Directorate D – Animal Health and Welfare 
3. Products covered (provide tariff item numb er(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where applicable):  Food preparations for infant use (H S:1901.10) and other positions under HS 
chapter 19; 2104 (Soups and broths and preparat ions therefore; homo genized composite food 
preparations); ICS numbers:  Milk and milk products (67.100) 
4. Regions or countries likely to be affected, to the extent relevant or practicable :  
Member States of the European Communities (E C) and third countries exporting the products 
concerned to the EC. 
5. Title, language and number of pa ges of the notified document:  Draft Commission 
Regulation amending Regulation (EC) No 2073/2005 on microbiological criteria for 
foodstuffs  (SANCO/1797/2006/Rev.6) (30 pages) 
6. Description of content:  This proposal aims at amending cert ain microbiological criteria in 
Regulation (EC) No 2073/2005 in particular with regard to Salmonella , Enterobacte r 
sakazakii , Enterobacteriaceae and Bacillus cereus  in dried infant formulae and dried dietary 
foods for special medical purposes for infant s below six months old, and dried follow-on 
formulae. The food safety criteria would apply to the internal market and also to the imported 
products, while sampling and verifying of pr ocessing hygiene criteria shall be done by 
authorities only at the production establishments.  
7. Objective and rationale:  [ X ] food safety, [   ] animal health,  [   ] plant protection, 
[ X ] protect humans from animal/plant pest or disease,  [   ] protect territory from other 
damage from pests    
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:  To the extent possible, this proposal complies 
with the Recommended International Code of Hy gienic Practice for Foods for Infants and 
Children (CAC/RCP 21-1979) of Codex Alimentarius Commission .  
This proposal follows the advice of the Eu ropean Food Safety Authority (EFSA). See 
references in Item 9. G/SPS/N/EEC/312 
Page 2  
 
  9. Relevant documents and langu age(s) in which these are available:    
Regulation (EC) No 882/2004 of the European Parliament and of the Council of 
29 April 2004 on official controls performed to  ensure the verificati on of compliance with 
feed and food law, animal health and animal welfare rules , final act notified in 
G/SPS/N/EEC/191/Add.2, (1 June 2004). 
Regulation (EC) No. 852/2004 of the Europe an Parliament and of the Council of 
29 April 2004 on the hygiene of foodstuffs , final act notified in G/SPS/N/EEC/94/Add.2, 
(7 June 2004). 
Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological 
criteria in foodstuffs , final act notified in G/SPS/N/ EEC/263/Add.1 (22 February 2006). 
Scientific opinion of BIOHAZ P anel on the request from the Commission for review of the 
opinion on microbiological risks in infant form ulae and follow-on formulae with regard to 
Enterobacteriaceae as indicators , adopted on 24 January 2007, available at: 
http://www.efsa.europa.eu/en/s cience/biohaz/biohaz_opinions/e j444_infant_formulae.html
  
Opinion of the Scientific Panel on Biological  Hazards on Bacillus cereus and other Bacillus 
spp in foodstuff s, adopted on 26-27 January 2005 available at:  
http://www.efsa.europa.eu/en/scien ce/biohaz/biohaz_opinions/839.html   
Opinion of the Scientific Panel on Biological Hazards on the request from the Commission 
related to the microbiological risks in infant formulae and follow-on formulae , adopted on 
9 September 2004 available at:  
http://www.efsa.europa.eu/en/scien ce/biohaz/biohaz_opinions/691.html  
10. Proposed date of adoption:  October 2007 
11. Proposed date of entry into force:  20 days following its publication in the Official Journal. 
12. Final date for comments:  Sixty (60) days after th e date of notification 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] EC enquiry point, or address, fax number a nd E-mail address (if 
available) of other body: 
13. Texts available from:  [   ] National notifi cation authority, [ X ] EC enquiry point, or 
address, fax number and E-mail address (if available) of other body: 
E-mail: sps@ec.europa.eu