WORLD TRADE  
ORGANIZATION   
G/SPS/N/EU/32 
3 August 2012 
 (12-4307) 
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 & 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):  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 Implementing Regulation on 
applications for authorisation of genetically  modified food and feed in accordance with 
Regulation (EC) No 1829/2003 of the Eur opean Parliament and of the Council and 
amending Regulations No (EC) 641/2004 and (EC) No 1981/2006"  
Language(s):  English  Number of pages:  74 
 http://members.wto.org/crnattach ments/2012/sps/EEC/12_3072_00_e.pdf  
6. Description of content:  The draft Regulation introduces implementing rules concerning 
applications for authorization 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. 
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    G/SPS/N/EU/32 
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  [ ] 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 authorization 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  
Legal documents available in all the EU official languages. 
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  
(available in English) 
10. Proposed date of adoption (dd/mm/yy) :  November 2012 
Proposed date of publication (dd/mm/yy) :  November 2012 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  December 2012 (Transitional provision: for six months following publication 
applicants may choose to submit applicati ons under Regulation (EC) No 64/2004)  
[ ] Trade facilitating measure    G/SPS/N/EU/32 
 Page 3 
 
 
  12. Final date for comments:  [X] Sixty days  from the date of circulation of the 
notification and/or (dd/mm/yy) :  2 October 2012 
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 29 98090 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 29 98090 
E-mail:  sps@ec.europa.eu