. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/307 
4 June 2007 
 (07-2281) 
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, Enterprise & Industry 
Directorate-General Directorate F – Consumer Goods 
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):   Foodstuffs of animal origin (0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 
0209, 0210)  
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:  Proposal for a regulation 
of the European Parliament and of the Council laying down procedures for the 
establishment of residue limits of pharmacologi cally active substances in foodstuffs of 
animal origin and repealing Regulation ( EEC) N°2377/90 (COM (2007)194, 27 pages - 
available in all European Community languages) 
6. Description of content:   The proposed Regulation replaces and simplifies the existing 
Council Regulation on Maximum Residue Levels (MRLs) for veterinary medicinal products 
in foodstuffs of animal origin namely Re gulation (EEC) N°2377/90.  It also introduces 
provisions at EC level for the establishment of  so-called "reference points for action" in 
order, where appropriate, to ensure harmonize d functioning of controls of food of animal 
origin imported or placed on the EC market a nd for which no MRL  is or was established. 
These new provisions are expected to stimulate innovation and improve availability of 
veterinary medicinal products and aim at: 
-  improving the availability of veterinary me dicinal products for food producing animals in 
order to ensure animal health and welf are and avoid illegal use of substances; 
-  providing clear references for the control of residues of pharmacologically active 
substances in foodstuffs to improve consumer health protection and the functioning of the 
Single Market; 
-  clarifying the EC procedures establis hing MRLs by ensuring consistency with 
international standards; 
 - simplifying the existing legislation by enhancing readability of the provisions on 
established MRLs for the end-users (i.e. anim al health professionals, control competent 
authorities in Member states and third countries). G/SPS/N/EEC/307 
Page 2  
 
  7. Objective and rationale: [ X ] food safety,  [ X ] animal health,  [   ] plant protection, 
[   ] 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:   
Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines 
priorities for the consideration of residues of  veterinary drugs in foods and recommends 
Maximum Residue Levels (MRLs) for veterinary drugs. http://www.codexalimentari us.net/web/index_en.jsp  
The current proposal aims in particular at clarifying the EC procedures establishing MRLs 
for veterinary drugs by ensuring consistency with international sta ndards. In opposition to 
the current practices in application to Regul ation N°2377/90, it is proposed to adopt Codex 
MRL standards for veterinary drugs, for wh ich the European Communities voted in favour 
of their adoption in Codex Alimentarius Commission, without
 an additional scientific 
assessment by the European Medicines Agency (EMEA). 
9. Relevant documents and language(s) in which these are available:  European Union 
Document: COM (2007) 194 (available in all community languages) 
10. Proposed date of adoption:  This proposal follows the procedure established by 
Article 251 of the Treaty (Co-decision) and although it is expected to be adopted by 
May 2009 , this date may be different according to its progress through the European 
Parliament. 
You can get information on the evolution of any Commission proposal through the 
European Parliament and the Counc il, by consulting "Eur-Lex" at: 
http://eur-lex.europa.eu/en/index.htm  
Select "Preparatory acts" and then CO M documents, and introduce the COM number 
(N°.194 ) you will arrive at: 
http://eur-lex.europa.eu/LexUriSe rv/site/en/com/2007/com2007_0194en01.pdf  
11. Proposed date of entry into force:  Twenty (20) days after its publication in the Official 
Journal of the European Union ( June 2009 ). 
12. Final date for comments:  Ninety  (90) days after the date of notification. 
Agency or authority designated to handle co mments:  [ X ] EC 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 ] EC enquiry point, or 
address, fax number and E-mail address (if available) of other body:   
English / French / Spanish text available from: 
http://eur-lex.europa.eu/LexUriSe rv/site/en/com/2007/com2007_0194en01.pdf  
http://eur-lex.europa.eu/LexUriServ /site/es/com/2007/com2007_0194es01.pdf  
http://eur-lex.europa.eu/LexUriServ /site/fr/com/2007/com2007_0194fr01.pdf