. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/59 
6 August 2012  
 (12-4311) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt involved (Article 3.2 and 7.2):     
2. Agency responsible:  European Commission 
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above :   
European Commission 
EU-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
Website:  http://ec.europa.eu/enterprise/tbt/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other:   
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may 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.  
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Implementing Regulation on applications for au thorisation of genetically modified food and 
feed in accordance with Regul ation (EC) No 1829/2003 of the European Parliament and of 
the Council and amending Regulations No (EC)  641/2004 and (EC) No 1981/2006 (74 pages, 
in English).      
6. Description of content:  The draft Regulation introduces implementing rules concerning 
applications for authorisation for the placing on  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 identi fication and reference material as defined by Regulation (EC) 
No 1829/2003 on GM food and feed.  
7. Objective and rationale, including the na ture of urgent problems where applicable:  
This draft Regulation aims at giving guidance to  applicants for author isation of genetically 
modified food and feed so as to ensure that the submitted application is complete in the sense that it fulfils the applicatio n criteria as defined by Re gulation (EC) No 1829/2003 on GM 
food and feed.  G/TBT/N/EU/59 
Page 2  
 
  8. Relevant documents:   Regulation (EC) No 1829/2003 of the European Parliament and of the 
Council of 22 September 2003 on genetically m odified food and feed, OJ L 268, 18.10.2003.  
http://eur-lex.europa.e u/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 1829/2003 of the European Parl iament and of the 
Council as regards the application for the author isation of new genetically modified food and 
feed, the notification of existing products and adventitious or technically unavoidable 
presence of genetically modi fied material which has bene fited from a favourable risk 
evaluation, OJ L 102, 7.4.2004. http://eur-lex.europa.e u/JOHtml.do?uri=OJ:L :2004:102:SOM:EN:HTML  
Commission Regulation (EC) No 1981/2006 on deta iled rules for the implementation of 
Article 32 of Regulation (EC) No 1829/2003 of th e European Parliament and of the Council 
as regards the Community reference laborato ry for genetically modified organisms. 
http://eur-lex.europa.e u/JOHtml.do?uri=OJ:L :2006:368:SOM:EN:HTML  
9. Proposed date of adoption:   
Proposed date of entry into force:    November 2012 
December 2012 (Transiti onal provision: for 
6 months following public ation applicants may 
choose to submit applications under Regulation (EC) No 64/2004). 
10. Final date for comments:  60 days from date of notification. 
11. Text available from:  National enquiry point [  ], or address, telephone and fax numbers, 
e-mail and web-site addresses, if available of the other body:    
European Commission 
EU-TBT Enquiry Point 
Fax:  +(32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu   
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/   
http://members.wto.org/crnatt achments/2012/tbt/EEC/12_3094_00_e.pdf