WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/263 
19 July 2005 
 (05-3212) 
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 E – Food Safety: Plant Health, Animal Health and Welfare, International questions 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):   
Meat and edible meat offal [CN chapter 02], Fish and crustaceans, molluscs and other aquatic 
invertebrates except Live fish [CN chapter 03, except heading 0301], Dairy produce, birds' eggs; natural honey, edible pr oducts of animal origin [CN 04], Edible vegetables [CN 
chapter 07], Edible fruit and nuts [CN chapte r 08], Margarine [CN 1517], Preparations of 
meat, of fish or of crustaceans, molluscs or other aquatic invertebrates [CN chapter 16], 
Preparations of cereals, flour, starch or milk [CN chapter 19], Preparations of vegetables, fruit, nuts [CN chapter 20], Miscellaneous ed ible preparations [CN chapter 21].  
ICS numbers:
  Food products in general (67.040); Fruits. Vegetables (67.080); Milk and 
milk products (67.100); Meat, meat products a nd other animal produce [including fish and 
fishery products] (67.120); Prepacked and prepared foods (67.230). 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Member States of the European  Communities (EC) and third countries exporting  to the 
EC. 
5. Title, language and number of pages of the notified document:   Draft Commission 
Regulation on microbiological criteria for foodstuffs (SANCO/4198/2001/Rev.18) (available in English, 40 pages). 
6. Description of content:  This proposal aims among other things to harmonise the different 
microbiological criteria used by the Member States of the EU, thus facilitating trade within 
the European Union and importing third countries.  Examples can be food safety criteria for salmonella (minced meat, meat preparations), Listeria monocytogenes  (ready-to-eat 
foods) , staphylococcal enterotoxins (certain dair y products) and histamine (certain fishery 
products).  In addition, the proposal establishes process hygiene criteria, such as salmonella 
in slaughter carcases, staphylococci in certa in type of cheeses.  The food safety criteria 
would apply to the internal market and also  to the imported products, while sampling and 
verifying of process hygiene criteria shall be done by authorities only at the production establishments. G/SPS/N/EEC/263 
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  Background:  
Regulation (EC) No 852/2004 of the Europ ean Parliament and of the Council of 
29 April 2004 on the hygiene of fo odstuffs, notified in G/SPS/N/EEC/94 
(18 September 2000), sets that food business ope rators shall, as appropriate, adopt specific 
hygiene measures.  This draft text notifie d hereby sets implementing measures concerning 
microbiological criteria on foodstuffs.  Accordi ng to this proposal, food business operators 
have to implement a sampling and testi ng plan to ensure compliance with the 
microbiological requirements.  Competent Authorities shall verify compliance of the food business operators.  
7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from anima l/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 that it is possible, this propos al complies with the following international 
standard: 
1) Recommended International Code of  Hygienic  Practice for Dried Milk (CAC/RCP 31-
1983, amended in 1989) of C odex Alimentarius Commission . In the draft Regulation no 
criteria for aerobic mesophilic bacteria and coliform bacteria, but criteria for coagulase-
positive staphylococci and staphyloco ccal enterotoxins are included. 
2) Recommended  International Code of Hygienic Practice for Foods for Infants and 
Children (CAC/RCP 21-1979) of Codex Alimentarius Commission . The microbiological 
criteria for dried infant formulae are in accord ance with the proposed draft revision of the 
Codex Code. 
3) Codex Standards  for fishery products concerning histamine criteria (70-1981, Rev.1-
1995; 94-1981, Rev.1-1995; 119-1981, Rev.1. -1995; 36-1981, Rev.1-1995; 190-1995; 165-
1989 Rev.1-1995; 166-1989, Rev.1-1995). 
When no international standard is available, the proposal follows the advice of the European 
Food Safety Authority (EFSA). 
9. Relevant documents and language(s) in which these are available:  Document 
SANCO/4198/2001/Rev.18 "Draft Commission Re gulation on microbiological criteria for 
foodstuffs".  At present available in Englis h, but will be translated to all Community 
languages.  When a dopted it will be published at the Official Journal available at:  
http://europa.eu.int/eur-lex/en/oj/index.html . 
Other relevant documents:  
Regulation (EC) No. 852/2004 of the Eur opean 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. 
Regulation (EC) No 882/2004 of the Eur opean Parliament and of the Council of 
29 April 2004 on official controls performed to  ensure the verification 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.  G/SPS/N/EEC/263 
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 10. Proposed date of adoption:   The aim is to adopt the Draft Regulation by the end of 
September 2005. 
11. Proposed date of entry into force:   1 January 2006. 
12. Final date for comments:  Sixty (60) days after the date of notification. 
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:  [ X ] National notification authority, [   ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: