. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/EEC/369 
26 January 2010 
 (10-0377) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  EUROPEAN UNION
 
If applicable, name of local government involved:    
2. Agency responsible:  European Commission, Health & Consumers Directorate-General 
Directorate Directorate E – Safety of the food chain 
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):  Genetically modified plants (GM plants) for food/feed uses, food/feed 
containing or consisting of GM plants and food/feed produced from GM plants 
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:  "Draft Commission Regulation on implementing rules 
concerning applications for authorisation of  genetically modified food and feed in 
accordance with Regulation (EC) No 1829/200 3 of the European Parliament and of the 
Council and amending Regulations No (EC) 641/2004 and (EC) No 1981/2006 " 
Language:  English  Number of pages:  66 
http://members.wto.org/crnattach ments/2010/sps/EEC/10_0372_00_e.pdf  
6. Description of content:  The draft Regulation introduces implementing rules concerning 
applications for authorisation for the placing onto the market of genetically modified food 
and feed.  It provides for rules on the preparation and presentation of the application as well as for the requirements for the risk assessment, post-market monitoring regarding food and 
feed, methods of detection and identificati on and reference material as defined by 
Regulation 1829/2003 on GM food and feed. 
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) Guideline for the Conduct of Food Safety Assessment of Foods 
Derived from Recombinant-DNA Plants (CAC/GL 45-2003);  Codex principles and guidelines on foods derived from biotechnology. G/SPS/N/EEC/369 
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?   
 [X] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language(s) in which these are available:  Regulation 
(EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and f eed, OJ L 268, 18 October 2003  
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2003:268:SOM:EN:HTML
 
Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the 
implementation of Regulation (EC) No 1829/20 03 of the European Parliament and of the 
Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products  and adventitious or technically unavoidable 
presence of genetically modified material which has benefited from a favourable risk 
evaluation, OJ L 102, 7 April 2004 http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2004:102:SOM:EN:HTML
 
Commission Regulation (EC) No 1981/2006 on de tailed rules for the implementation of 
Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council 
as regards the Community reference laborat ory for genetically modified organisms 
http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:368:SOM:EN:HTML    
Also information relevant to this proposal can be found on the website of DG Health and 
Consumers at:   
http://ec.europa.eu/food/food/biot echnology/gmo_authorisation_en.htm    
10. Proposed date of adoption (dd/mm/yy) :  May 2010 
Proposed date of publication (dd/mm/yy) :  May 2010 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  June 2010 
[ ] Trade facilitating measure   
12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  27 March 2010 
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:   
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:    
sps@ec.europa.eu