. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/231 
23 November 2004 
 (04-5087) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
 
NOTIFICATION  
 
1. Member to Agreement notifying:   CANADA  
If applicable, name of local government involved: 
2. Agency responsible:   Department of the Environment and Department of Health 
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):  Organisms (ICS: 13.020, 07.100) 
4. Regions or countries likely to be affected, to the extent relevant or practicable:  not 
stated  
5. Title, language and number of pages of the notified document:   Proposed New 
Substances Notification Regulations (Organisms ) (available in English and French;  pages 
3083-3101) 
6. Description of content:   
The purpose of the proposed New Substances Notification Regulations (Organisms)  [the 
"proposed Regulations"] is to implement pa rt of a new regulatory structure for new 
substances notification under the Canadian Environmental Protection Act, 1999  ("the 
Act").  The proposed regulatory structure carves out the provisions related to organisms in the existing New Substances Notification Regulations  (NSNR).  
 Background 
 
The New Substances Program ("NS Program")  ensures that no new substance (chemical, 
polymer, or living organism) is imported into, or manufactured in, Canada before a formal 
assessment of its potential risks to the environment and human health has been completed and any appropriate risk manageme nt measures have been taken.  Parts I, II and III of the 
NSNR  for chemicals and polymers came into forc e in 1994, and were amended in 1997 to 
include both provisions for biochemicals and biopolymers (G/TBT/Notif.96/327) and Part 
II.1 for new substances that are organisms (G/SPS/N/CAN/13).   The proposed Regulations are part of a new regulatory structure that divides the NSNR into 
two distinct Regulations:  
 1. New Substances Notification Regulati ons (Chemicals and Polymers) , which apply to 
chemicals (including biochemicals) and polymer s (including biopolymers) that are for a 
use not covered under other federal legislati on listed in Schedule 2 of the Act;  and  
 
2. New Substances Notification Regulations (Organisms) , which apply to living organisms 
that are for a use not covered under other federa l legislation listed in Schedule 4 of the Act. G/SPS/N/CAN/231 
Page 2  
 
 Such living organisms may include micro-or ganisms used in bioremediation or micro-
organisms used for the production of biochemicals or  biopolymers (e.g. enzymes).  
 
New Substances Notification Re gulations (Organisms)  
 Despite the significant change in the overarchi ng regulatory structure for the notification of 
new substances, there are only minor amendmen ts to the provisions relating to organisms 
previously contained in Part II.1 of the NSNR and now contained within the proposed Regulations. Three additional changes in the proposed Regulations are more substantive, 
but nonetheless have no cost implications fo r notifiers or the Government of Canada. 
7. Objective and rationale:  [   ] food safety, [   ] animal health, [   ] plant protection, 
[ X ] protect humans from anima l/plant pest or disease,  [   ]  protect territory from 
other damage from pests 
8. International standard, guideline or recommendation:  
[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [ X ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:    
9. Relevant documents and language(s) in which these are available:  Canada Gazette, Part 
I, 30 October 2004 (available in English and French) 
10. Proposed date of adoption:   Normally within 5 to 8 mont hs of publication in the Canada 
Gazette, Part I. 
11. Proposed date of entry into force:   early 2005 
12. Final date for comments:  29 December 2004 
Agency or authority designated to handle comments:  [   ] National notification 
authority, [ X ] National enquiry point, or  address, fax number and E-mail address (if 
available) of other body:    
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body: 
The electronic version of the regulat ory text can be downloaded at:  
http://canadagazette.gc.ca/partI/2004/20041030/pdf/g1-13844.pdf