WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/465 
3 September 2010  
 (10-4565) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English/ 
 French 
 
 
  
NOTIFICATION 
 
1. Notifying Member:  CANADA
 
If applicable, name of local government involved:    
2. Agency responsible:  Health Canada 
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):  Bread, flour, whole wheat flour and unstandardized bakery products  (ICS 
Code: 67.060, 67.220) 
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:  Interim Marketing Authorization regarding the use of the 
cellulase and xylanase enzymes in the produc tion of bread, flour, whole wheat flour and 
unstandardized bakery products  Language:  English and French  Number of pages:  2   
6. Description of content:  Health Canada has received a submission to permit the use of the 
enzymes cellulase and xylanase derived from a genetically modified Trichoderma reesei  
RI-P37, Trichoderma reesei  A83, in the production of bread, flour, whole wheat flour and 
unstandardized bakery products at maximu m levels of use consistent with good 
manufacturing practice.  Evaluation of availabl e data supports the safety and effectiveness 
of cellulase and xylanase derived from Trichoderma reesei  A83 in the production of bread, 
flour, whole wheat flour and unstandardized ba kery products at maximum levels of use 
consistent with good manufacturing practice. 
Therefore, it is the intention of Health Ca nada to recommend that the Regulations be 
amended to permit the use of cellulase and xylanase derived from Trichoderma reesei  A83 
in the production of bread, flour, whole wheat flour and unstandardized  bakery products at 
maximum levels of use consistent  with good manufacturing practice. 
As a means to improve the responsiveness of th e regulatory system, an Interim Marketing 
Authorization is being issued to permit the immediate use of cellulase and xylanase derived 
from Trichoderma reesei  A83 in the production of bread, flour, whole wheat flour and 
unstandardized bakery products at maximu m levels of use consistent with good 
manufacturing practice while the regulator y process is undertaken to amend the 
Regulations. G/SPS/N/CAN/465 
Page 2  
 
  The proposed regulatory amendments would be  enabling measures to allow the sale of the 
foods mentioned above that ha ve been manufactured through the use of the cellulase and 
xylanase derived from Trichoderma reesei A83.  The amendments are supported by the 
safety assessment and would have low impact  on the economy and on the environment.  
Consequently, the regulatory amendments ma y proceed directly to final approval and 
publication in the Canada Gazette , Part II. 
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:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number 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 regulation conform to the relevant international standard?   
 [ ] 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:  Canada 
Gazette , Part I, 28 August 2010, Pages 2321-2322 (available in English and French) 
10. Proposed date of adoption (dd/mm/yy) :  Immediate for this IMA.  For the final regulation, 
normally within 12-18 months of publication of the Notice of Interim Marketing Authorization in the Canada Gazette , Part I, 28 August 2010. 
Proposed date of publication (dd/mm/yy) :    
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Immediate for this IMA.  For the fi nal regulation, normally within 12-18 
months of publication of the Notice of Interim Marketing Authorization in the Canada 
Gazette , Part I, 28 August 2010. 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  11 November 2010 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:     G/SPS/N/CAN/465 
 Page 3 
 
 
  13. Texts available from:  [ ] National Notification  Authority, [X] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:    
The electronic version of the regulatory text can be downloaded at:   
http://www.gazette.gc.ca/rp-pr/ p1/2010/2010-08-28/p df/g1-14435.pdf  (Canada Gazette ) 
or  
http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-08-28/html/notice-avis-eng.html#d110  
(English) http://www.gazette.gc.ca/rp-pr/p1/2010/ 2010-08-28/html/notice-avis-fra.html#d110
 
(French)