. /.   WORLD TRADE  
ORGANIZATION  G/SPS/N/CAN/397 
19 August 2009  
 (09-3951) 
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 uns tandardized bakery products (ICS 
Codes 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 
xylanase enzyme, derived from a genetically modified Aspergillus niger , Aspergillus niger 
(XYL-2)(pXYL3), in the production 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 
xylanase enzyme, derived from a genetically modified Aspergillus niger , Aspergillus niger 
(XYL-2)(pXYL3), that carries a xylanase gene from Aspergillus niger LYX-68.  This xylanase will be used in the production of bread, flour, whole wheat flour and 
unstandardized bakery products such as cakes at levels consistent with good manufacturing 
practice.  Evaluation of available data supports  the safety and effectiveness of this xylanase 
derived from Aspergillus niger (XYL-2)(pXYL3) in these food products. 
Therefore, it is the intention of Health Canada to recommend that the Food and Drug 
Regulations be amended to permit the use of this xylanase derived from Aspergillus niger 
(XYL-2)(pXYL3) in the production of bread, flour, whole wheat flour and unstandardized 
bakery products at levels consiste nt 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 th e immediate use of this xylanase as indicated 
above, while the regulatory process is undertaken to amend the Regulations. 
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 xylanase from 
Asperigillus niger (XYL-2)(pXYL3).  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. G/SPS/N/CAN/397 
Page 2  
 
  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, 8 August 2009, Pages 2294-2 295 (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, 8 August 2009. 
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, 8 August 2009. 
[ ] Trade facilitating measure 
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  22 October 2009 
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:    
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/ p1/2009/2009-08-08/p df/g1-14332.pdf  (Canada Gazette) 
or  http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-08-08/html/notice-avis-eng.html#d109
 
(English) 
http://www.gazette.gc.ca/rp-pr/p1/2009/ 2009-08-08/html/notice-avis-fra.html#d109  
(French)