WORLD TRADE  
ORGANIZATION   
G/SPS/N/EU/20 
17 April 2012 
 (12-2047) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  EUROPEAN UNION 
If applicable, name of local government involved:    
2. Agency responsible:  European Commission, Health and Consumers Directorate-General  
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):  Cereals (HS Codes: 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008), 
foodstuffs of animal origin (HS Codes: 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210) and certain products of plan t origin, including fruit and vegetables 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Annexes to "Draft Commission Regulation amending 
Annexes II and III to Regulation (EC) No 396/20 05 of the European Parliament and of the 
Council as regards maximum residue levels for 2,4-DB, dimethomorph, indoxacarb and 
pyraclostrobin in or on certain products"   Language(s):  English   Number of pages:  12 
 http://members.wto.org/crnattach ments/2012/sps/EEC/12_1383_00_e.pdf  
6. Description of content:  These notified annexes to the draft Regulation set proposed 
maximum residue levels (MRLs) for 2,4-DB, dimethomorph, indoxacarb and pyraclostrobin are set in Annex II to Regulation (EC) No 396/2005.  MRLs for these substances in certain commodities are changed: either increased or lowered.  Higher MRLs 
are set to accommodate new uses in the Eur opean Union and in third countries which 
export those commodities to the European Union.  Lower MRLs are set after updating the limit of determination and/or deleting old uses which are not authorized any more in the European Union or for which there is not enough data for an MRL to be set. 
7. Objective and rationale:  [X] food safety, [ ] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from other damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text) Codex Maximum Residue Limits for dimethomorph, indoxacarb 
and pyraclostrobin for some commodities. G/SPS/N/EU/20 
Page 2  
 
  [ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [X] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:  The European Food Safety Authority published reasoned 
opinions on the existing MRLs for dimethomorph, indoxacarb and pyraclostrobin. Based on these opinions the Regulation (EC) No 396/2005 should therefore be amended following a 
risk analysis approach. 
9. Other relevant documents and language (s) in which these are available:  "Regulation 
(EC) No 396/2005 of the European Parliament  and of the Council of 23 February 2005 on 
maximum residue levels of pestic ides in or on food and feed of plant and animal origin and 
amending Council Directive 91/414/EEC". 
"http://eur-
lex.europa.eu/LexUriServ/LexUriServ. do?uri=CONSLEG:2005R0 396:20080410:EN:PDF " 
Reasoned opinions published by the European Food Safety Authority on the setting of new 
MRLs for 2,4-DB, dimethomorph,  indoxacarb and pyraclostrobin. 
http://www.efsa.europa.eu/en/efsajournal/pub/2420.htm :  MRLs for 2,4-DB  
http://www.efsa.europa.eu/en/efsajournal/pub/2348.htm :  MRLs for dimethomorph 
http://www.efsa.europa.eu/en/efsajournal/pub/2437.htm :  MRLs for dimethomorph in 
spinach and beet leaves  
http://www.efsa.europa.eu/en/efsajournal/pub/2343.htm :  MRLs for indoxacarb 
http://www.efsa.europa.eu/en/efsajournal/pub/2344.htm :  MRls for pyraclostrobin 
http://www.efsa.europa.eu/en/efsajournal/pub/2606.htm :  MRLs for pyraclostrobin in leafy 
brassica and various cereals. 
(available in English) 
10. Proposed date of adoption (dd/mm/yy) :  June 2012 
Proposed date of publication (dd/mm/yy) :  October 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  November 2012 
[ ] Trade facilitating measure    G/SPS/N/EU/20 
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  12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  16 June 2012.  Comments welc ome only to update MRLs 
(in bold in attached annexes). 
Agency or authority designated to handle comments:  [X] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:   
European Commission 
DG Health and Consumers, Unit G6 - Multilateral international relations 
Rue Froissart 101 B 1049 Brussels Tel:  +(32 2) 29 68185/59922 Fax:  +(32 2) 2998090 
E-mail:  sps@ec.europa.eu 
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:    
European Commission  
DG Health and Consumers, Unit G6 - Multilateral international relations 
Rue Froissart 101 B 1049 Brussels 
Tel:  +(32 2) 29 68185/59922 
Fax:  +(32 2) 2998090 E-mail:  sps@ec.europa.eu