G/SPS/N/EU/172  
 
9 November 2016  
(16-6145) Page: 1/2 
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 Food Safety Directorate -
General  
3. Products covered (provide tariff it em number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in 
addition, where applicable): Genetically modified organisms intended for deliberate 
release into the environment, including genetically modified food and feed  
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 Directive amending Directive 
2001/18/EC of the European Parliament and of the Council as regards the environmental 
risk assessment of genetically modified organisms . Language(s): English . Number of 
pages: 4 + 15 of Annex  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_4657_00_e.pdf  
http://members.wto.org/crnattachments/2016/SPS/EEC/16_4657_01_e.pdf  
6. Description of content:  This draft Directive updat es certain annexes to 
Directive  2001/18/EC as regards the environmental risk assessment of GMOs, in order 
to adapt them to technical progress and in the light of the Guidance documents of the 
European Food safety Authority concer ning the environmental risk assessment of 
genetically modified plants. The list of information that notifyers must provide under 
Directive 2001/18/EC is also updated accordingly.  
7. Objective and rationale: [ ]  food safety, [X]  animal health, [ ]  plant pr otection, 
[X] protect humans from animal/plant pest or disease, [ ]  protect territory 
from other damage from pests.   
8. Is there a relevant international standard? If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial numb er of Codex 
standard or related text) :   
[ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :   
[ ] International Plant Protection Convention (e.g.  ISPM number) :   
[X] None  
Does this proposed regu lation conform to the relevant international standard?   
[ ] Yes   [ ] No  G/SPS/N/EU/172  
 
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  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:  
10. Propos ed date of adoption (dd/mm/yy) : To be determined.  
Proposed date of publication (dd/mm/yy) : To be determined.  
11. Proposed date of entry into force: [ ]  Six months from date of publication , 
and/or  (dd/mm/yy) : To be determined.  
[ ] Trade facilitating measur e   
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 8 January 2017  
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 Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu  
13. Text(s)  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 Food Safety, Unit D2 -Multilateral International Relations  
Rue Froissart 101  
B-1049 Brussels  
Tel: +(32 2) 29 54263  
Fax: +(32 2) 29 98090  
E-mail: sps@ec.europa.eu